“I never dreamed I would be on the cover of magazines, interviewed on radio and television programs, testify to Congress, meet with elected officials, and speak to huge groups of people,” marveled Garner in an interview with The AIDS Beacon.

He probably never imagined his name would become such a symbol of hope, either. As a leading HIV and AIDS activist, Garner travels the country speaking to the public, advocating for people living with HIV, and participating in AIDS-related walks, health fairs, and conferences.

He does all this on behalf of his organization, the Dab the AIDS Bear Project.

Founded in 2003, the project helps Garner spread awareness about Americans on waiting lists for AIDS Drug Assistance Programs (ADAPs). These programs help qualifying, uninsured individuals obtain free HIV and AIDS medications.

Current government funding for these programs is not sufficient to meet the needs of everyone who applies; over 1,000 people have been placed on waiting lists for ADAPs (see related Beacon news).

Garner’s foundation raises awareness of the issue in an attempt to spur additional funding for ADAPs.

“Now that we have life-saving, anti-HIV medications, it is a disgrace to allow the needless deaths of American men and women,” said Garner.

Garner also expressed his anger and frustration in regard to Florida starting an ADAP waiting list beginning June 1.

“Too many of my friends and loved ones lost their battle before we had medication. I would be dishonoring their deaths and memories if I didn’t speak out.”

When HIV first started appearing in 1981, Garner sent teddy bears to friends who were dying in quarantine from the disease and unable to receive visitors.

In 1998, when funding for the Ryan White Act was being cut, Garner began mass-producing the bears and sold them in retail stores throughout the country. When he and his friends began an organization to advocate on behalf of those with HIV, they decided to use Dab the AIDS Bear as their mascot.

“It just seemed natural to name the organization, started to fight needless deaths of Americans from HIV, after the teddy bears I had given to friends and loved ones to give them hope and strength over the years.”

Through the organization, Garner speaks across the country about HIV, AIDS, and ADAP waiting lists. He also writes blogs for various websites.

Through all of his work in spreading awareness, Garner’s journey with HIV and AIDS has been a remarkable one. His involvement in a broad range of endeavors has impacted the lives of countless patients and their families.

For Garner, however, life did not always run so smoothly.

On Valentine’s Day of 1982, when very little was known about HIV or AIDS, Garner was diagnosed with HIV. He was only 19 years old.

“At the time, it wasn’t even called HIV yet. In 1981, they were calling it ‘gay cancer’…and when I found out in early 1982, it was called GRID (Gay-Related Immune Deficiency).”

“All I knew about it was that I had watched two friends and my partner die horrible, painful, and lonely deaths while in quarantine, which broke my heart.”

Garner was hospitalized and told that he would probably not live to celebrate his 20th birthday, only six weeks away. When Garner returned home after his hospital stay, he thought he was “living a death sentence.”

“It was like always waiting for the other shoe to drop. At that time, we did not know a rare few could live many years with HIV, since most died shortly after being diagnosed,” said Garner.

Fortunately, Garner’s family members were all very supportive, although he did lose some friends who could not accept the fact that he had the “new” disease.

“It showed me who my true friends were. I’d rather be hated for who I am than loved for someone I am not.”

It has now been 28 years since Garner was first diagnosed. He has had seven different infectious disease doctors, a general practice physician, and – due to related conditions over the years – various specialists, such as cardiologists, oncologists, and neurologists.

His advice? “The trait I look for in a doctor is someone who is willing to work with me on my treatment and really listen to what I have to say,” said Garner.

He also has kept up with the latest information on HIV and AIDS by participating in clinical trials, many of which have led to the current HIV/AIDS therapies available to patients. He keeps in contact with infectious disease doctors in several cities and has served on the board of HIV and AIDS organizations.

He also emphasizes maintaining good health by taking medications, keeping a healthy diet and exercise level, and using protection when engaging in sexual activities to avoid getting STDs or additional strains of HIV.

“HIV is not a death sentence. With today’s anti-HIV medications, you can live a normal life expectancy as long as you take your medications as needed and follow sound health practices,” said Garner.

Over the years he has managed to stay pretty healthy, which is a good thing – he has a lot of work to do.

Garner’s volunteer work started out local, helping various AIDS Service Organizations. Eventually he found himself leading committees, then initiating support groups in cities where he lived. Today, Garner advocates nationwide for people living with HIV.

His biggest accomplishment? Working with Senator Kennedy to pass the Ryan White Act in the 1980s, he said.

“Because of Ryan White Funding, 600,000 Americans with HIV have a chance of living with the virus.”

This year, he testified in front of Congress to support extending Ryan White Funding for four more years.

The Dab the AIDS Bear Project also has a program known as the Ambassadors of Hope Project. Currently, the program enlists 143 Ambassadors of Hope who travel the world, speaking about ADAP waiting lists and spreading awareness through Dab the AIDS Bears.

Finally, the Dab the AIDS Bear Project hosts holiday events for children across the country.

“In our country, children with HIV and AIDS have so much to deal with daily. It’s hard enough just being a kid,” said Garner.

To ease some of these challenges and make the holidays enjoyable, the organization’s holiday events, known as Teddy Bear Touchdowns, provide gifts for children whose families are dealing with the financial hardship of expensive medical care.

For Garner, the Teddy Bear Touchdowns program is one of his biggest activism-related accomplishments.

“Seeing their smiles and laughter as they open their presents is the best Christmas present I could ever receive…Some of them have brought me to tears, telling me it is the only present they get during the holidays.”

“It reminds me of how my little god-daughter used to love the holidays and the promise I made to her to bring happiness and joy to other children like her,” said Garner of his god-daughter who passed away from complications due to AIDS in 1989 at age five.

Garner advises people who are newly diagnosed with HIV to take advantage of opportunities and live life to the fullest.

“Life is not a dress rehearsal, so get out there and make the most of every day. None of us, regardless of HIV status, are guaranteed tomorrow.”

For more information on Dab Garner and his efforts, please see the Dab the AIDS Bear Project website.

“HIV would be a blessing,” Carr recalls being told at the clinic where he had been tested. Testing positive, they told him, meant eligibility for a whole range of social services. Finally, he was told, “My homelessness would be over. I would have access to medical care, and everything would be taken care of.”

“That couldn’t have been further from the truth,” he said.

At the appointment, Carr was told he would be found a place to recover his strength. Carr, instead, found himself in a cubicle in an abandoned warehouse battling a staph infection so severe he could barely walk.

What followed was a struggle back to health through the labyrinthine medical bureaucracy in Los Angeles. At one point, nine months passed before he could secure an appointment with a doctor.

The entire time, he struggled with what he feared he would become: “Another statistic on a CDC report,” he remembered. “I was going to be yet another black man who dies from AIDS – not because I wasn’t engaged in care. It’s because care wasn’t fully engaged in me, and it all goes back to me being homeless and being without. I was homeless, and homeless people don’t count, no matter what.”

Hopelessness followed Carr while he struggled to find housing. The barriers to getting a roof over his head came from unexpected places. In one instance, his doctor refused to sign a form that would secure him housing after months on the street. Depressed, Carr attempted suicide.

Eventually, he spoke to a representative at AIDS Project Los Angeles, an outreach organization in the city dedicated to advocacy and service, and they arranged for him to see another physician.

While Carr struggled to find medical care, he finally ended his 29 months of homelessness through assistance available to HIV-positive individuals on the street. With the help of Hollywood Community Housing’s Shelter Plus Care Program, offered through the Los Angeles Housing Authority, Carr finally made it to the top of the waiting list. The program secured for Carr the apartment he still calls home.

Through his experiences, he found sources of strength.

“I relied on me,” he said. “I relied on the very few friends I had. I always tried to believe in myself. I would get through it – it was going to be a whole lot of work.”

Today, that work continues as he maintains his health while giving back to people. Carr still has not begun therapy for his HIV, and he focuses more on reaching out to others, especially those worrying more about finding a place to live than tracking their viral loads.

His ultimate goal is “giving a face to people who are suffering in this country.”

A shameless lover of the Internet, Carr uses blogging and his talent for talking to connect with others as far away as Australia. On his blog, titled “Project KengiKat,” Carr writes about his daily experiences as a person living with HIV.

His use of the Web is not limited to blogging about what he has been up to lately, though. Carr started a social network, which began as a forum for raising awareness about homelessness and later blossomed into a site providing information and awareness about issues confronting those with HIV/AIDS. Today it also serves as a place where some of Carr’s favorites hang out.

Carr also maintains a YouTube channel to post videos that he hopes will inspire others. “Thank God for the Internet,” Carr said with a laugh. With his ability to find and connect with others, he can do more than simply worry about his health. “I can move forward,” he said.

Carr founded two outreach projects in Los Angeles, Do Something Saturday, which Carr began three years ago, and Unpluggin’ HIV, which is now a year old. Both are associated with The Leon and Mary Fields Organization.

Do Something Saturday provides services and support to low-income homeless people from every walk of life, while Unpluggin’ HIV targets low-income or homeless people with HIV or AIDS in Los Angeles’s Skid Row.

If someone who is HIV-positive and living on Skid Row needs hygiene products, Carr makes sure they have a tooth brush. If they need someone to talk to, they have his phone number.

To those who have lost hope in their lives, Carr dispenses the kind of advice that only someone who has lost hope before can offer.

“Remember a time when you felt you were worth it, and then try to get back to that place.” Regardless of one’s situation, Carr says, “Don’t lose faith in yourself. No matter what is in front of you.”

“I think I was kind of numb at first – suspicious that I might be positive, but hardly prepared to be given the news,” he said of his initial diagnosis.

Unfortunately, it was not his family’s first experience with HIV. Chaplin’s brother Craig was also diagnosed as HIV-positive prior to Chaplin.

“I was, and still am, part of some large support groups, so the night I got the news [of my diagnosis] I went to a meeting, told them about my day, cried as I did so, and was warmly hugged and supported by a room with many other HIV-positive people in it,” said Chaplin.

With what started as a personal year-end letter to his friends and family, Chaplin was drawn into the world of blogging and currently maintains a personal blog called “My Journey With AIDS,” in which he writes and updates about all aspects of his life.

“I include other issues in my blog because day-to-day interests, and even my life history, contribute to the big picture of ‘my journey.’”

Due to the strain and stress brought on from the disease, Chaplin left his job at an international reservations center for a Canadian hotel chain in 1990.

“I have never seriously considered going back to work, so I am trying to channel my limited energy into writing, which I have always liked to do,” explained Chaplin. “Interestingly enough, I was never one to keep a written diary. I simply lacked the discipline to do so, especially given my idea that it had to be an everyday thing. Blogging works better for me.”

When first diagnosed, Chaplin found himself constantly trying to learn more about HIV/AIDS and likened himself to a “student of medicine.” However, over the years, he has found it less necessary to know everything. Now, he tends to only update himself with essential information, such as treatment options.

Chaplin offered some advice to newly diagnosed patients: “Surround yourself with people you love and with whom you can trust to share the news of your HIV status. When times are difficult, they will offer you support that you would not necessarily seek from a professional. On the other hand, take advantage of any professional help you can. Many great people are trained to walk us through the early days of HIV diagnosis.”

Chaplin’s 21 years with HIV have not been easy. Immediately after diagnosis, he began treatment for depression, due to what he described as “survivor’s guilt.”

“There were waves of deaths among my peers, so I was involved with home-care teams and other community efforts to cope with what was unfolding, all the while believing I could be dead at any time,” Chaplin explained.

After a severe car accident in 2003, Chaplin battled post-traumatic stress disorder, which later led to a diagnosis of bipolar II disorder. In 2004, he was diagnosed with Type II diabetes, which initially came as a surprise to him. It is now speculated that this condition may be due to the long-term use of antiretrovirals, in particular protease inhibitors.

For Chaplin, support from his family and friends is what gives him the strength to survive.

“I have been inspired by the courage of those friends who were sick and died before better treatments came along, and I remain inspired by long-term survivors who continue to live into uncharted waters,” he said.

“Living with this disease can feel lonely sometimes, but remember there is not a large ‘plus’ sign on our foreheads. We can participate in life as fully as we wish and are able.”

For more information about Kenn Chaplin, please visit his blog, “My Journey With AIDS.”

About H1N1

Since its detection in the United States in April 2009, H1N1 “swine flu” has infected an estimated 50 million people, and has lead to approximately 10,000 deaths according to the Centers for Disease Control (CDC).

Over the following months, the CDC continued to update its recommendations regarding H1N1 flu as they were able to gather more information (for the most recent recommendations for HIV-positive individuals, see related Beacon News).

H1N1 is spread through person-to-person contact, often by sneezing or coughing, similar to transmission of the seasonal flu virus. Symptoms of the H1N1 flu and the seasonal flu both include a cough, sore throat, runny nose, body aches, headache, chills, tiredness, and sometimes fever, vomiting, and diarrhea.

Although the seasonal flu appears in different strains every year, H1N1 flu currently has only one strain. Compared to the seasonal flu, H1N1 is very contagious, and affects younger people more.

There are certain groups of people who are more at risk for complications from H1N1, including pregnant women, young children, and people with weakened immune systems, such as those with HIV and AIDS.

In an interview, Senior Policy and Medical Advisor at amfAR Dr. Susan Blumenthal said, “So far, [H1N1 influenza] does not appear highly lethal, but what’s worrisome is that it’s affecting young people and pregnant women and people who have underlying medical conditions, such as HIV/AIDS.”

Prevention

In order to prevent contracting H1N1 influenza, HIV patients should continue to maintain a healthy lifestyle, which includes taking all antiretroviral medications. In addition, they should make sure to get vaccinated for both the seasonal and H1N1 influenzas.

Frequent hand washing with soap and water can help prevent the transmission of the virus. When coughing or sneezing, individuals should always do so in the crook of their arms, or into a tissue that should later be disposed. People at risk for H1N1 flu should avoid places with large crowds. If this is not possible, they should make certain to wear a face mask when in contact with others.

Vaccines

In September of this year, the FDA approved two forms of the H1N1 flu vaccine: the injectable intramuscular vaccine and the nasal spray vaccine. Both forms contain H1N1 virus; however, the injectable form contains the killed virus, while the nasal spray form contains weakened live virus.

Individuals with HIV and AIDS should only take the injectable form, as recommended by the CDC.

Note that only HIV-infected people within the ages of 24-65 are currently on the priority list for receiving an H1N1 vaccine. This group is considered most at risk; individuals 65 and older, including those with HIV, are considered to be at lower risk for contracting the virus.

The CDC also recommends that people with HIV make sure that all their vaccinations are up to date, and that they have been vaccinated against Streptococcus pneumoniae, which causes bacterial pneumonia and can be a complication of flu infection.

Treatment

H1N1 “swine flu” can be treated with the antiviral drugs Relenza (zanamivir) or Tamiflu (oseltamivir). These drugs reduce the severity of the symptoms associated with the illness and can also improve survival rates.

If symptoms of H1N1 flu are present, it is important to start antiviral treatment within 48 hours of the onset of symptoms. It is not necessary to wait for laboratory confirmation of influenza in order to begin antiviral treatment. Individuals with a suspected H1N1 flu infection should contact their doctor to discuss whether treatment with antivirals is appropriate.

No adverse interactions have been reported between antiretrovirals and Relenza or Tamiflu.

In some cases, HIV-positive patients might be given antivirals as a preventive measure (called “chemoprophylaxis”), if they have been in close contact with someone who has likely been exposed to H1N1 flu.

Research Regarding H1N1 Flu And HIV/AIDS

So far, there is no evidence that people with HIV are more likely to get H1N1 flu; however, the risk for complications may be greater in HIV-positive individuals.

According to Dr. Blumenthal, research is currently underway to determine how H1N1 will impact individuals included in the CDC’s risk groups.

Additionally, The National Institute of Allergy and Infectious Diseases is currently looking for HIV-positive volunteers to participate in research to determine the most effective dosage of the H1N1 vaccine in HIV-infected patients (see related Beacon News) and HIV-infected pregnant women and children (see related Beacon News).

For more information, please see the amfAR Web site and the CDC’s H1N1 Information Page for people who are HIV-positive.

HIV-positive individuals face two options regarding dating: date another individual who is infected with the virus, or date an individual who is HIV-negative.

A greater understanding of the infection, and the use of condoms, has reduced the likelihood of an HIV-negative individual acquiring the virus, if they are in a romantic relationship with someone who is HIV-positive.

These couples are known as serodiscordant partners.

However, dating while infected with the virus poses many questions.

Should infected individuals date only others who are also infected? If they begin dating someone who is HIV-negative, when should they disclose their status – before the first date? Or once a mutual interest in each other has been established?

Internet users are split on these issues.

“Ask Mona Lisa,” an advice column on About.com, has offered guidance to people writing in on this topic.

“Give [the person] a chance to get to know you as a person and not you as your status. Go out on a few dates and see how things develop,” Mona Lisa replied.

In an article published in Survival news, author David Salyer said it is most important to disclose one’s status before engaging in any sexual activity.

However, others feel that it is best to be upfront about being HIV-positive before the first date. This way there are no surprises and the individual is being honest with a potential romantic interest.

By practicing safe-sex, the risk of transmitting HIV to a non-infected partner can be greatly reduced.

A study conducted by the New England Journal of Medicine followed 415 mixed-status couples in Uganda for 30 months.

By the end of the study, 22 percent of HIV-negative individuals acquired HIV. Of those who acquired HIV, 56 percent were female.

Male to female transmission of the virus is more frequent during vaginal sex for several reasons.

First, the volume of semen secretions is greater than cervical secretions, according to Dr. Maria Patterson, who treats HIV positive children at Sparrow Hospital in Lansing, Michigan.

Also, abrasions to the vaginal wall during traumatic intercourse make it easier for the virus to enter a female.

Patterson stated that is it hard to measure the transmission rate for HIV, versus other infections such as gonorrhea. It is believed that female to male transmission in serodiscordant couples is less than 1 in 1000, according to Patterson.

The authors in the study on serodiscordant couples noted that there was a low instance of condom use in the study, due to the region of the world in which it was conducted.

The study also analyzed the role of viral loads, or amount of virus in the blood, in acquiring HIV.

It was concluded that viral load is the main indicator of whether a HIV-negative partner will acquire the virus. The study said that transmission is rare in individuals with viral loads of less than 1,500 copies per milliliter of blood.

Sexual Activity With Other HIV-Positive Individuals

Two people already infected with HIV may believe no harm can occur from having unprotected sex.

However, this is not the case.

A superinfection can occur. This is when a person already infected with HIV is later infected with a different strain of the virus.

Research has indicated that there is a time period when an infected individual is most likely to be re-infected with a second strain. This is most likely to occur within the first three years of infection.

A study published in PLoS One states that being infected with more than one strain of the virus could potentially lead to resistance against certain types of antiretroviral medications.

While much remains unknown about a superinfection, researchers believe that its occurrence is more prevalent than previously thought.

The study indicated that prior research has shown that superinfections existed in four to eight percent of HIV infected women studied in Kenya. This rate may be as high as 19 percent in the high-risk areas of Tanzania.

A superinfection can also result in increased viral loads, according to AIDSMap, a non-profit organization in the United Kingdom.

Higher viral loads can weaken the immune system, meaning the virus is reproducing more copies in the body.

The best way to prevent a superinfection from occurring is to always use a condom with any type of sexual activity. Minimizing the number of sexual partners with HIV also decreases the likelihood.

Online Dating Web Sites

Several online-dating Web sites exist for HIV positive individuals.

Positive Dating is an online service that aims to help HIV positive individuals “make new friends, form romantic relationships, meet life partners, or even receive helpful guidance and advice from others in the HIV-positive community.”

HIV Passions is another online Web site that helps connect people looking for romance, friendship, or emotional support.

Membership is free and members also have access to HIV discussion boards.

She received her Ph.D. in virology from Northwestern University in 1970 and attained her medical degree from Michigan State University in 1984. She currently works at Sparrow Hospital in Lansing, Michigan and is also a faculty member of the Department of Pediatrics and Human Development at Michigan State University.

In 2008, Patterson was recognized at Michigan’s 14th Annual STD & HIV Conference and was given the lifetime achievement award for her work with the disease.

Like many physicians, Dr. Patterson has an immense amount of knowledge in her area of expertise. However, what makes her unique is her sense of care and compassion.

She has seen stories of success and sorrow, and each patient that has died has a special place in her heart. She has always made it a point to attend the funerals of her patients who died.

“It is always very rewarding, even though it is sad,” she said. “You always get something from the kids themselves and their parents. For years after, I will call parents on a particular day that I think is important to them.”

Thankfully, treatment of AIDS is progressing, and HIV-positive children are living longer. More of Dr. Patterson’s patients are becoming success stories.

When she began practicing medicine in the mid 1980s, Patterson said that physicians were aware of adult AIDS. However, the presence of AIDS in pediatrics was not understood. The ability to diagnose and treat pediatric AIDS has progressed tremendously.

Early in her career, she saw many HIV-positive children and teenagers die from the disease or a secondary complication.

“Ninety percent of HIV-positive children did not live to five years old. Nearly 50 percent would not even live to be a year old,” Patterson said.

However, her last patient who died passed away in 1999. This is a good indicator of the advancements that have occurred in the last 10 years.

With advancements in antiretroviral therapy, Patterson said it is rare for an HIV-positive child not to live past their first birthday. If children are adherent to their medication throughout the rest of their lives, it is quite likely they will have a normal lifespan.

Patterson’s patients range from pregnant mothers, to toddlers, to teenagers. She discussed the different needs that each of her patients face as they progress into young adults.

Before a child is born, many actions need to be taken to ensure the virus is not transmitted from mother to child.

“Without any medical intervention, there is about a 25 percent chance of transmitting the virus during childbirth,” Patterson said.

“To prevent transmission to the infant, the mother is given zidovudine (Retrovir) during pregnancy, intravenous zidovudine during delivery, and the baby is given zidovudine by mouth for several months after birth.”

This technique became widespread after positive results were obtained from a clinical trial conducted in 1994. With further advancements, the transmission rate is only one to two percent today. Depending on the health and viral loads of the mother, additional treatments may be used. Delivering the baby by cesarean section is also used to reduce the risk of transmission.

The last child that Patterson saw born HIV-positive was in 2005 to a mother who was a drug user. Before this, the last child she saw born with HIV was in 1997. However, Patterson said that in her community, 4 out of 1,000 live births are to moms who are HIV-positive.

In most cases, by four months of age, it can be determined if a child born to a mother with HIV has contracted the virus.

“If this test is negative at four months, I suggest the infant obtain one final test at 18 months to be certain,” Patterson said.

If it is determined that the child does not have HIV, Patterson advises mothers that breastfeeding must be avoided to ensure the virus is not transmitted by this medium.

For some of her patients, the importance of adhering to this is not fully conveyed. One patient of hers, who lived in Africa, said there was no way she could not breastfeed her child because of the stigma that AIDS carries in this region; not breastfeeding is an indicator that the mother is HIV-positive.

Patterson realizes that there is much progress to be made in developing countries to prevent the spread of AIDS and increase the longevity of those infected.

“I think we are definitely winning the battle in the western world. To win it in the developing world, it is so much harder,” she said.

Every year in the United States, less than 200 children are born HIV-positive.

If a child is found to be HIV-positive, they should begin treatment immediately and expect to see a doctor every three months for check-ups.

Medication is taken twice daily and is usually a combination of three or more antiretroviral drugs. Patterson said children often do not experience as many bad side-effects as adults do on these medications.

“Children tend to handle [medications] much easier [than adults]. Early on, moms would not want to start their children on these medications and would say ‘I don’t want my child to have these problems from it that I have experienced,’” Patterson said.

At the beginning of the epidemic, often times children born with HIV/AIDS would face severe developmental problems, including difficulties with speech, movement, coordination, and balance. This can occur because the virus may affect the brain.

“Since 1997, we don’t see [developmental delays] anymore. Even before this, we knew that with pediatrics we wanted the medication to reach the central nervous system. If you began treating you always began with two drugs, one of these would go through the blood-brain barrier,” she said.

While Patterson acknowledges that it can be challenging living with HIV, she believes a relativity normal life can be led.

Although Patterson must report a child’s HIV status to the health department, she said it is not required to disclose this information to day cares or schools.

“You don’t have to worry about their feces, saliva, and tears transmitting the virus [only contact with blood]. However, I usually like to say, ‘When you begin elementary school, choose one person, whether it is a principal, a school nurse, or a favorite teacher. Inform them of the child’s medical status. Someone at school should know just for safety reasons,’” she said.

However, the most important point that Patterson stressed in order to live a relatively normal life is to be adherent to medications.

A challenge that Patterson has faced is treating many teenagers who are going through a phase of “invincibility.” When patients are children, they usually will strictly adhere to their medication regimen. However, once the teenage years begin, patients often forget how important it is to adhere 100 percent to treatment.

However, with strict adherence to medications, many of her teenage patients have thrived with controlling their disease and achieving academic and social success. One of her patients was a member of his varsity football team.

“I don’t know if we can say that HIV is like any other chronic illness. It is not exactly. You really have to be careful to adhere to your medications,” she said.

Currently, Dr. Patterson is involved in treating eight patients with AIDS, as well as other HIV-positive children who have been adopted from other countries. Patterson no longer practices full time in her clinic, but currently splits her time treating patients and teaching residents. She is also working to teach obstetricians the importance of testing for HIV in pregnant women.

Patterson is hopeful for the future. She believes new classes of drugs will be developed as researchers reexamine parts of the life cycle of the virus. These drugs may have less toxicity, may be administered once daily as a pill, or someday even once weekly.

She believes that eventually a vaccine, and maybe even a cure, will be found.

In 1990,the Americans with Disabilities Act (ADA) was passed to insure that individuals with disabilities were not discriminated against. HIV and AIDS are both considered disabilities under this law. However, the ADA only applies to public and private employers who have 15 or more employees.

Individuals are protected by this act only if they are employed in a setting with 15 or more workers and can perform their job duties. If special accommodations for individuals are necessary, they should be made as long as they do not posses a significant burden or financial cost to the employer.

Employers are also prohibited from asking if an individual is HIV-positive during the hiring process. However, they may inquire about a prospective employee’s overall health. If an individual wishes to disclose his or her HIV status to an employer, this information must remain confidential.

While those who are HIV-positive may face discrimination in the workplace, discrimination is most blatant when it pertains to health insurance.

Under the ADA, individuals employed by a company with 15 or more employees are entitled to the same health insurance that is provided to other employees. Individuals who are part of a group insurance under this condition cannot be denied coverage or required to take a test for HIV antibodies.

However, for people with HIV/AIDS who obtain individual policies, the same federal laws do not apply. Individual policies tend to be very costly. With these policies, insurers may ask about an individual’s HIV status. In many states, insurers may also require an individual to be tested for HIV before approving coverage.

The existence of AIDS and other preexisting conditions can result in the denial of or significantly higher rates for coverage. A preexisting condition is usually defined as a medical condition that existed before a patient has obtained health insurance. Conditions that a person has received treatment for, or should have received treatment for, are included in this definition.

Cindy*, a customer service representative from Blue Cross Blue Shield, said they will not deny coverage to an individual based on a preexisting condition.

“We are the insurers of last resort,” she said.

She added that many competing companies do not follow these same policies and will deny coverage based on preexisting conditions.

She also added that many times, people contemplate not disclosing their HIV status to insurance companies.

“This is never a good option because insurers will eventually discover the diagnosis from doctor’s visits receipts submitted for payment and medical records,” she said.

Intentionally hiding this information is also considered fraud and an individual will be dropped from coverage once fraud is discovered.

Insurance companies specifically for individuals with HIV/AIDS do exist. AIDS Health Insurance Program (AHIP) is available to those who are not eligible for Medicaid and cannot afford their own health insurance. However, an individual must be currently insured to participate and also have a monthly income no higher than $1,559 for single households or $2,096 for a household of two. AHIP pays health insurance premiums, excluding co-payments and deductibles.

The AIDS Drug Assistance Program (ADAP) and the Ryan White Program are both federally funded programs that assist low-income individuals with HIV/ AIDS that have a yearly income less than $55,000. The ADAP provides HIV medication approved by the Food and Drug Administration to those with limited or no health insurance. This program runs in all 50 states. According to the ADAP Monitoring Project Annual Report, 3 out of 10 HIV-positive individuals have received assistance from this program.

The Ryan White Program provides funding to low-income cities to help provide services for people with HIV. Specifically, this program pays for emergency room visits, dental visits, laboratory costs, transportation, and housing assistance for uninsured or under-insured individuals with HIV.

For more information on finding assistance programs in your area, visit the Health Resources and Services Administration.

*It is Blue Cross Blue Shield’s policy to not disclose employees’ last names

At the time,“No one else was doing this and people didn’t think it was possible with insurance, immigration and other factors,” Fleming said.

However, in 2003 Chances by Choice was formed and has since placed about 60 HIV-positive children with families. The ages of these children range from infants and toddlers to older children about 10 years old.

Chances by Choice, a program of Adoption-Link since 2006, provides services for families looking to adopt children in third world countries, such as Haiti and Ethiopia. They are hoping to develop programs soon in Russia and Kazakhstan.

Fleming said that many people who want to adopt children with HIV are not first time adopters, since adoption in general is a big step. However, she has worked with individuals who planned on adopting a healthy baby, but ultimately adopted one with HIV.

“We often see larger families with a number of adoptive kids wanting to adopt those with HIV,” she said. Unlike many parental requirements at traditional adoption agencies, Chances by Choice’s only minimum requirement is that potential adopters are at least 21 years old. If adopters are married, it must be for at least one year. Chances by Choice does not discriminate and also welcomes unmarried and same sex couples. These same requirements apply for individuals looking to adopt a healthy child through their main program, Adoption-Link.

Adoption requirements are usually more lenient for special needs children, such as those with HIV. However, different countries do have their own rules for adoption regarding marriage length and parent age.

Adoption Advocates International, an adoption agency focusing on children from Ethiopia, China, Thailand, Ghana, and Washington State, said requirements differ in each of these countries.

In Ethiopia, with traditional adoptions of healthy children, couples must be married for a minimum of two years and there can be no more than a forty-three years age difference between the youngest adopting parent and the child. However, if parents are looking for special needs children or older children, these requirements can be altered. Single women are also allowed to adopt HIV-positive children.

In China, some agency requirements state that couples must be 30 to 55 years old to be eligible to adopt. If a parent is over 50 years old, they must be willing to consider a special needs child. Also, if one parent was previously divorced and remarried at the time of adoption, the current marriage must have existed at least five years.

Drawbacks in the Adoption Process

Since relatively few children with HIV are born in the U.S. today, most parents seeking HIV-positive children must look internationally. The process usually takes about a year and requires traveling to that country for a period of time, ranging from a few days to several weeks. For this reason, parents looking to adopt newborn infants find more success domestically.

Parents adopting a child with HIV must also have an extra document signed, an I-601 waiver of inadmissibility from the U.S. Citizenship and Immigration Services (USCIS). People with a “communicable disease,” such as tuberculosis and HIV, as defined by the Centers for Disease Control and Prevention (CDC) are required to have this waiver, since they are currently ineligible to receive a visa under the Immigration and Nationality Act.

The I-601 waiver must be processed by the CDC, the state department, and the USCIS, and previously took from three to nine months to process. The waiver currently should take no more than 10 days to process, according to J. McLane Layton, founder and President of Equality for Adopted Children (EACH).

Layton is currently advocating for the waiver to be completely eliminated, which hopefully will take place in the next few years. However, earlier this year, an amendment was proposed that would lift the ban of HIV-positive individuals entering the country, at which time people with HIV could be eligible for a visa and therefore would not require the I-601 waiver (related Beacon news).

EACH is a non-profit organization that works to promote adoption polices and legislative changes to ensure that adopted children have the same legal rights as biological children in the U.S.

“When families adopt internationally, the government treats that child as an immigrant, not an American,” Layton said. “We [at EACH] are a voice for adoptive children and families on Capitol Hill.”

Another delay that adoptive parents may face relates to new tuberculosis (TB) protocol issued by the CDC in 2007.

New testing and treatment rules have been established for immigrants older than 2 years of age, including those adopted by U.S. citizens. The protocol went into effect in April in Ethiopia and in July in China, two countries that have been frequently utilized by U.S citizens seeking to adopt.

This protocol, which includes a positive TB skin test, has affected non-HIV and HIV children being adopted from these countries. Upon receiving a positive result, the child is required to have mucus from the lungs cultured, the results of which typically take eight weeks to return.

According to Layton, in most instances, the TB positive skin test is determined after the child has already been adopted and is waiting to travel to the U.S. However, the adopted child cannot enter the U.S until the results of the test have been returned.

About two weeks ago, after much media attention on this issue, the CDC issued an addendum to this protocol. If a child 10 years of age or under has a positive TB skin test, a mucus culture from the lungs is still required. However, while waiting for these results to return, if the mucus specimen is examined under a microscope and found to have no mycobacterium tuberculosis (the bacteria that causes TB), the child may travel to the U.S. The results of this rapid test take about three days. If it is negative, the child can immigrate into the U.S.

Success Stories

Both Fleming and Layton have also found success in their own lives with adopting international children. Fleming recalls the scene when she adopted her daughter with HIV from an orphanage in Vietnam.

“The women [at the orphanage] said to me, ‘Why do you want this baby? You don’t want her; you want a baby that is big and healthy.’ I told them, ‘No I want her,’” she said.

Fleming has adopted several other children, including three that have HIV. Her one son was one of four children born with HIV in Chicago that year. She says all of her children are nothing but delightful. Fleming has been open with her church, her children, and neighbors about her three children’s HIV status. However, she has not felt the least bit of discrimination from anyone in her community.

All of her children play, share drinks, and interact with each other just as any other siblings would do. The only restriction they have is to not touch any blood from their siblings with HIV. Fleming said that, besides giving her children with HIV their medicine daily, they are able to live fully normal lives.

“Raising a child with HIV is often less work than caring for a child with juvenile diabetes,” Fleming said.

Layton has also adopted three siblings from an orphanage overseas, which inspired her to advocate for child adoption laws.

“If you want to make a big impact in the world, this is something to do,” Layton said.

Chances by Choice encourages families to look into adopting children with HIV. For more information about adopting HIV-positive children, visit the Chances by Choice Web site.

For individuals needing advice or having problems with the I-601 waiver form, visit Equality for Adopted Children.

Please see Part 1 of this series, “AIDS and Adoption – Part 1: Can I Adopt If I Am HIV-Positive?” which discusses adoption if you are HIV-positive.

An alternative solution for many facing this dilemma is adoption. However, even if couples are certain this is the right choice for them, some adoption agencies see HIV as a red flag to disqualify prospective couples from adopting.

In 1990 the Americans with Disabilities Act was passed to insure that those with disabilities were not discriminated against in employment, public service, public accommodations, and telecommunications. This law protects individuals with HIV who are both asymptomatic (showing no symptoms) and symptomatic. While it is unconstitutional for adoption agencies to disqualify prospective adopters solely on an HIV diagnosis, they are allowed to reject the applicant if other factors exist that determine the prospective parents are unqualified.

Ann Wrixon, executive director of the Independent Adoption Center of Los Angeles, said that her agency has successfully worked with HIV-positive individuals who have been rejected by other agencies.

Wrixon believes that other adoption agencies may reject potential adopters upon hearing of their disease because they “are not educated about HIV and make the assumption that birthparents would be upset [if their child were adopted by an HIV-positive couple].”

At the Independent Adoption Center, all prospective adopters are required to get a medical evaluation from their physician(s) indicating the status of their health. If either one of the prospective parents has HIV, they will need a letter from their physician stating their prognosis and also indicating they are healthy enough to adopt.

Wrixon said that her agency conducts open adoptions. This allows the birthparents and adopting parents to have contact with one another during the adoption process. They can also mutually select each other.

While at first birthparents may be hesitant to chose an HIV-positive individual for their child, the Independent Adoption Center explains how the present medical treatments for HIV have greatly improved their quality of life and prognosis. In most cases birthparents will not object.

Catholic Charities USA, another adoption agency that provides pregnancy counseling and adoption services, said a couple will not be disqualified to adopt if one or both people have HIV. Instead, the agency takes into consideration the person’s age, progression of the disease, and other factors to determine parenting abilities.

The National Center for Adoption Law and Policy, according to its Web site, is an organization that seeks to improve the law, policies, and practices associated with child protection and adoption.

Executive director Denise St. Clair is not aware of any state laws that require HIV testing be conducted before adoption, although some agencies may require medical examinations before adopting.

“There is not a blanket law that prohibits someone with HIV from adopting,” she said. “Adoption is a very individualized process and factors may be different in every situation. [Adoption agencies] want to make sure that everything is done in the best interest of the child.”

St. Clair added that an adoption agency may unlawfully discriminate, which can often be hard to substantiate because of all the factors involved in making the decision.

Adopters choosing to participate in open versus closed adoption may also face different outcomes. A closed adoption is one where no contact or exchange of information occurs between birthparents and those adopting.

While the Independent Adoption Center has found success with open adoptions, others considering open adoptions may not experience the same successes. Birthparents may unfairly reject a potential adopter because he/she is HIV-positive. It is uncertain whether the rejection is based on discrimination or their ability to be an effective parent due to their medical condition.

Those considering international adoptions may face an outright rejection based on their medical diagnosis. International agencies do not have to comply with U.S. laws and some countries will not adopt children to those with HIV. For same-sex couples with HIV looking to adopt, the issue may become even more complicated as same-sex marriage and adoption is not lawful in every state.

For HIV-positive individuals who decide adoption is the right choice for them, the process can be challenging but rewarding. Available resources include The Independent Adoption Center, which is licensed in California and can help prospective adopters in all 50 states. The National Center for Adoption Law and Policy can also advise people on legal issues regarding adoption.

For more information on adopting children or legal guidance relating to adoption, visit The Independent Adoption Center or The National Center for Adoption Law and Policy, respectively. Additionally, part 2 of this series, “AIDS and Adoption – Part 2: Adopting an HIV-Positive Child” discusses adoption of HIV-positive babies.

Description

Sustiva is a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) approved by the U.S. Food and Drug Administration for HIV-1-positive adults and children older than 3 years of age.  For patients beginning antiretroviral therapy for the first time, the U.S. Department of Health and Human Services lists Sustiva as the preferred NNRTI option for use with at least two other HIV medications.  Sustiva must be taken in combination with other antiretroviral drugs, usually two or three, in drug regimens known as Highly Active Anti-Retroviral Treatment (HAART).

In addition, Sustiva is combined with Viread (tenofovir) and Emtriva (emtricitabine) in one pill under the brand name Atripla.  This combination is appealing to many patients because an entire HAART regimen can be administered once a day in the form of one pill.

Sustiva has not been adequately tested in patients older than 65 years of age, and dosage recommendations and side effects are not established for these patients.

Mechanism of Action

Sustiva prevents HIV from replicating in infected cells by blocking the reverse transcriptase enzyme.  This enzyme is responsible for transcribing the virus’s RNA into DNA to insert into the genetic material of an infected cell.  By blocking the enzyme, the HIV copy cannot inject its genetic material into the cell, preventing CD4 cells from creating more copies of the virus.

History

Sustiva was originally produced by DuPont Pharmaceuticals, but is currently manufactured by Bristol-Myers Squibb.  The drug is marketed in the U.S., Canada, and a few European countries.  Stocrin (efavirenz), the brand name of the drug in Europe, is manufactured by Merck Sharp & Dohme.

Use in HIV

Sustiva is most effective when taken early in a patient’s treatment plan.  The drug is recommended both for patients beginning therapy for the first time as well as for treatment-experienced patients who have not developed resistance to other NNRTIs.

Patients who have developed resistance to other NNRTIs such as Viramune (nevirapine) or Rescriptor (delavirdine) are more likely to have resistance to Sustiva as well.  Similarly, patients with developed resistance to Sustiva are more likely to show resistance toward other NNRTIs.

Dosage and Administration

For adults and children weighing more than 40 kilograms, the recommended dosage of Sustiva is one 600 milligram (mg) tablet taken once a day on an empty stomach before sleeping.  Eating food before taking Sustiva may increase the intensity of side effects.  HIV-positive children who are three years of age or older can take the drug, but must take the appropriate amount based on the child’s age and weight.

Sustiva is administered through 600 mg tablets or capsules with 50 mg and 200 mg doses.  Researchers are currently developing an oral solution of the drug for patients (especially children) who have problems swallowing pills.  Bristol-Myers Squibb offers the oral solution through an expanded access program designed for patients who are unable to receive treatment because of problems of administering or swallowing pills.

Like other medications, Sustiva should be stored at room temperature away from moisture and heat to ensure the drug’s effectiveness.

If a patient forgets to take a dose of Sustiva, he or she should take the missed dose as soon as possible.  The next dose should still be taken at the regularly scheduled time.  On the other hand, if a patient misses a dose but realizes it within a few hours of the next scheduled dose, he or she should not take the missed dose, but should instead take Sustiva at the next scheduled time.

A physician should be notified immediately if a patient is suspected to have overdosed on Sustiva.  Symptoms of over-dosage include severe confusion, lack of balance or coordination, severe behavioral changes, or thoughts of suicide.

Side Effects

Common side effects associated with Sustiva occur more frequently during the first two weeks of use.  Because of reported psychotic side effects including hallucinations, delusions, and confused speech or behavior, researchers highly recommend Sustiva be taken before bed.  In most patients, the majority of side effects clear up within a few weeks of starting the drug.  Patients should notify their physicians if any side effects persist past a few weeks or if any side effects worsen.  Additionally, using alcohol or the use of recreational drugs can significantly worsen side effects associated with Sustiva.

Dizziness, trouble sleeping, drowsiness, trouble concentrating, unusual dreams, cough, blurred vision, muscle or joint pain, fat redistribution, rash, upset stomach, vomiting, constipation, and diarrhea are common side effects of Sustiva.  These side effects usually disappear after a few weeks of treatment.

Patients with the following side effects should notify their physician:

• Severe depression
• Strange or hallucinogenic thoughts
• Suicidal thoughts
• Physical aggressiveness
• The combination of a headache, fever, or sore throat with a severe skin rash
• The combination of nausea, stomach pain, yellowing of the skin or eyes (jaundice), dark urine, and clay-colored stools
• The combination of fever, flu-like symptoms, and body chills
• Any signs of new infection
• Immune reconstitution syndrome, or an inflammation response to opportunistic infections (infections that do not occur in individuals with healthy immune systems) not previously felt or visible.

After Sustiva became available for public use, some patients committed suicide while taking Sustiva.  The FDA reported these cases, but cannot establish a causal relationship between suicide and taking the drug.  Patients should be aware of the psychotic effects of the drug and discuss any strange or suicidal thoughts with a health care professional.

Rashes can pose greater health threats to children than adults, so any rash developments in children taking Sustiva should be reported to a physician immediately.

Drug Interactions

Patients considering taking Sustiva should discuss all medications with their physician before starting the drug.  This includes all prescribed, over-the-counter, and herbal medications.  Sustiva can cause some medications to be less effective or can increase the severity of some side effects.  Likewise, certain medications can increase or decrease the amount of Sustiva in the bloodstream, altering the effectiveness of the drug.

Sustiva should not be taken with other NNRTIs or Atripla, which already contains Sustiva.  Administering these combinations will increase the risk of resistance or overdosing.

The following medications should not be taken with Sustiva:

• Hismanal (astemizole) or terfenadone (Seldane), two antihistamines
• Intelence (etravirine), another NNRTI
• midazolam or triazolam (Halcion), two sedatives
• Orap (pimozide), an antipsychotic
• Priftin (rifapentine), an antibiotic
• Propulsid (cisapride), an acid reflux medication
• Vascor (bepridil), a heart medication
• Vfend (voriconazole), an antifungal
• Wigraine (ergotamine and caffeine) or Cafergot (ergotamine tartrate and caffeine), two ergot (fungus) medications

The following medications interact with Sustiva, altering the effectiveness of both drugs:

• Biaxin (clarithromycin), an antibiotic
• Channel blockers including diltiazem, felodipine (Plendil), nicardipine hydrochloride (Cardene), nifedipine, verapamil
• ketoconazole (Perkhotal and Nizoral), an antifungal
• Mycobutin (rifabutin), an antibacterial used to prevent prevent Mycobacterium avium complex (MAC) disease
• Rifadin (rifampin), an antibiotic used to treat tuberculosis
• Sporanox (itraconazole), an antifungal used for yeast infections and other fungal infections
• Viagra (sildenafil citrate) and Levitra (Vardenafil hydrochloric acid), two erectile dysfunction medications

All Nucleoside Reverse Transcriptase Inhibitors (NRTIs), which also block the reverse transcriptase enzyme, can be taken safely with Sustiva.

Sustiva can reduce the amount of Protease Inhibitors (antiretroviral drugs that target the enzyme protease) in the bloodstream.  Sustiva can reduce amounts of Agenerase (amprenavir), Crixivan (indinavir sulfate), Invirase (saquinavir mesylate), Kaletra (liponavir and ritonavir), Lexiva (fosamprenavir) or Reyataz (atazanavir) in the blood stream.

Sustiva can also increase the amount of Kaletra, Viracept (nelfinavir), and Norvir (ritonavir) in the bloodstream.  In addition, taking Sustiva with Norvir can increase the amount of Sustiva in a patient’s bloodstream.

Patients should discuss these interactions with their physician to adjust dosages of other antiretrovirals (if needed).

Sustiva can also limit the effectiveness of birth control contraceptives.  Women taking Sustiva should use reliable forms of barrier contraception such as condoms or a diaphragm in addition to taking birth control to prevent transferring HIV to another individual.

Precautions

Because Sustiva causes mild to severe drowsiness and some psychotic side effects, patients taking the drug should not drive a car or operate heavy machinery immediately after taking a dose.  Patients taking Sustiva should also avoid medicines used for anxiety, the common cold or allergy, narcotic pain, muscles relaxation, severe depression, sedation, or seizures to avoid increased drowsiness.

Sustiva can take weeks to be entirely eliminated from a patient’s body, so patients considering switching from Sustiva to other medications should consult their physician about how to safely transition between two regimens without encountering drug interactions or increasing the possibility of developing resistance.  Patients taking Atripla should be cautious of these interactions as well.

Women who are pregnant or breastfeeding should talk to a doctor before taking Sustiva.  The FDA lists Sustiva as a “Category D” threat, which means there is evidence of human fetal risk based on reported experiences or studies in humans.  On the other hand, the potential benefits of Sustiva may warrant its use in some pregnant women despite the potential risks.  Pregnant women who are taking Sustiva can register for the Antiretroviral Pregnancy Registry through their physicians.  The registry is a voluntary study that allows researchers to collect data on the effects of antiretroviral treatments on pregnancies.  Participating in the registry can potentially help other pregnant, HIV-positive patients weigh their options.

Although it is not clear whether Sustiva can be transferred through breast milk, HIV-positive women should not breastfeed because of the possibility of the virus being transferred to the child.

Patients with HIV who also have a history of liver conditions like hepatitis B or C should discuss possible dosage adjustments or side effects of Sustiva.  Patients with serious skin hypersensitivity in the past have increased risks when taking Sustiva.

Also, patients taking Sustiva who undergo drug screening for employment should notify the hospital or nurse conducting the test about taking the drug.  In some cases, Sustiva causes a “false positive” drug test for marijuana.

Ongoing Clinical Trials

Open:

Phase Undefined

• University Hospital, Geneva: Patient preference, sleep quality, and anxiety/depression: a randomized comparison of Intelence and Sustiva (SWITCH-EE) (NCT00792584)
• National Institute of Allergy and Infectious Diseases (NIAID): Pharmacokinetic study of anti-HIV drugs during pregnancy (NCT00042289)

Phase 2/3:

• French National Agency for Research on AIDS and Viral Hepatitis: Comparison of Viramune and Sustiva for the treatment of HIV-TB co-infected patients (ANRS 12146 CARINEMO) (NCT00495326)

Phase 4:

• Oswaldo Cruz Foundation: Randomized clinical trial to assess the efficacy and safety of concomitant use of rifampicin and Sustiva 600 X 800mg (IPEC-EFV) (NCT00533390)
• 407 Doctors: Once daily Epivir (lamivudine), Sustiva and didanosine (Videx) for HIV infection (NCT00214435)

Closed:

Phase 1/2:

• National Institute of Allergy and Infectious Diseases (NIAID): Safety and effectiveness of Emtriva (emtricitabine), Sustiva, and didanosine  in HIV infected children who have taken few or no anti-HIV drugs (NCT00016718)

Phase 2:

• Gilead Sciences: Study of the safety and efficacy of elvitegravir/Emtriva /Viread (tenofovir disoproxil fumarate)/GS-9350 (QUAD) versus Atripla(R) in HIV infected, antiretroviral treatment-naive adults (NCT00869557)

Phase 3:

• National Institute of Allergy and Infectious Diseases (NIAID): Anti-HIV drugs for treating infants who acquired HIV infection at birth (NCT00102960)
• Merck: A study to evaluate the safety and antiretroviral activity of MK0518 versus Sustiva in treatment naive HIV-infected patients, each in combination with TRUVADA(TM) (emtricitabine/tenofovir) (NCT00369941)
• International Medical Center of Japan: Comparing the effectiveness between ritonavir boosted Reyataz and Sustiva for the first HIV treatment (NCT00280969)

Phase 4:

• The National Centre in HIV Epidemiology and Clinical Research: ALTAIR – alternative antiretroviral strategies : a comparison of three initial regimens (NCT00335322)
• GlaxoSmithKline: KIVEXA (abacavir/lamivudine) vs TRUVADA, both administered with Sustiva, in ART-naive subjects (ASSERT) (NCT00549198)

More a more detailed listing of clinical trials involving Sustiva, please see the U.S. government’s clinical trials Web site.

Clinical Trial Results

A Phase 3, multicenter, randomized, open-label study to compare antiretroviral activity and tolerability of three different combination regimens (Sustiva + Crixivan, Sustiva + zidovudine (Retrovir) + Epivir, Crixivan + zidovudine + Epivir) in HIV-infected patients (2002): In this study, researchers analyzed the safety and effectiveness of Sustiva in various antiretroviral regimens.  One thousand two hundred and sixty-six patients were randomly assigned one of the three drug regimens.  The study concluded that Sustiva in combination with zidovudine and Epivir was the most effective in reducing viral load and sustaining it over a 168-week period.  Although patients in all three groups experienced steady increases in CD4 cell levels, individuals in the Sustiva, zidovudine, and Epivir group tolerated the treatment better than the other two treatments containing Crixivan.  Results from this trial can be found at the Bristol-Myers Squibb Web site (pdf).

A Phase 4, open-label, randomized, multicenter study to determine the safety and duration of viral suppression of continued therapy with one or two protease inhibitors + two nucleoside analogue reverse transcriptase inhibitor regimen versus substitution therapy with Sustiva + the same two nucleoside analogue reverse transcriptase inhibitors in HIV-infected patients (2000):  This study compared the effectiveness of Sustiva combined with two NRTIs to a regimen containing two PIs and two NRTIs over a 48-week period in 346 patients.  In one group, researchers administered two PIs and NRTIs.  Patients already taking PIs were allowed to continue treatment with those drugs.  The second group received Sustiva in combination with two NRTIs.  Researchers concluded that patients taking Sustiva had a longer viral progression, or time to viral failure, than the other group taking protease inhibitors and NRTIs.  In addition, the group taking Sustiva tolerated the new regimen as well as the other group.  Overall, this study established Sustiva as an effective alternative to the use of protease inhibitors for HIV therapy.  Results from this trial can be found at the Bristol-Myers Squibb Web site (pdf).

ACTG 364: virologic efficacy of Viracept (NFV) and/or Sustiva (EFV) in combination with new nucleoside analogs in nucleoside experienced subjects (1998): Researchers looked at the effectiveness of Viracept and Sustiva in suppressing viral loads to undetectable levels (less the 500 copies per milliliter of blood) during and directly after a 16-week period.  One hundred and ninety six patients were assigned to one of three treatment groups.  In one group, Viracept, a Sustiva placebo, and RTIs were administered, whereas the second group received a Viracept placebo, Sustiva, and RTIs.  The third group received Viracept, Sustiva, and RTIs with no placebos.  The study concluded that the introduction of Viracept or Sustiva (issued separately and together) were effective in viral suppression when combined with RTIs.  The combination provided viral suppression at and beyond week 16 of the study.  An abstract of the study can be found at the National Library of Medicine’s Web site.

Patient Assistance Programs

Bristol-Myers Squibb Patient Assistance Programs
http://www.bms.com/products/Pages/programs.aspx

Bristol-Myers Squibb Access Virology Patient Assistance Program
Application PDF

Partnership For Prescription Assistance
http://www.pparx.org/

Links of Interest

Hightlights of Sustiva’s Prescribing Information
http://packageinserts.bms.com/pi/pi_sustiva.pdf

Managing Sustiva’s Side Effects
http://www.aidsmeds.com/articles/SustivaTips_7550.shtml