Shionogi-ViiV Healthcare Starts Phase 3 Trial for ’572-Trii Fixed-Dose Combination HIV Therapy – Shionogi-ViiV Healthcare has announced the start of a Phase 3 clinical study to test the efficacy and safety of ’572-Trii, a new fixed-dose combination therapy for the treatment of HIV. The proposed treatment combines the investigational integrase inhibitor S/GSK1349572 and ViiV Healthcare’s combination nucleoside reverse transcriptase inhibitor Epzicom (abacavir/lamivudine). The trial will compare ’572-Trii to Atripla (efavirenz/emtricitabine/tenofovir) in treatment-naïve adults over a 48 week period. For more information, please see the ViiV Healthcare press release. For information on the clinical trial, please see the U.S. Clinical Trials Registry.

FDA Suspends Phase 2 Clinical Trial For Investigational Anti-HIV Drug GSK2248761 – The FDA has suspended a Phase 2 clinical trial for the investigational non-nucleoside reverse transcriptase inhibitor GSK2248761. No reason for the suspension has been given, but Aidsmeds.com has reported that the suspension was due to four reports of seizures. The purpose of the trial was to find the optimal dose of GSK2248761 in treatment-experienced patients. GSK2248761 was developed by Idenix Pharmaceuticals and is currently licensed by ViiV Healthcare. For more information, please see the Idenix press release. For more information on the clinical trial, please see the U.S. Clinical Trials Registry.

Adoption Agency Develops HIV/AIDS Toolkit to Educate Prospective Parents – Bethany Christian Services, a Michigan-based adoption agency, has announced the creation of an HIV Adoption Toolkit for couples considering adopting children living with HIV/AIDS. The toolkit is designed to educate prospective adoptive parents on the medical, social, and psychological aspects of adopting a child with HIV. The toolkit is free to prospective parents looking to adopt with Bethany Christian Services and available online to anyone for a fee. For more information, please see the press release or the toolkit at Bethany Christian Services.

By the end of this year, an estimated 25 million children around the world will have lost one or both parents to AIDS, including thousands of children in the U.S. At the end of 2008, nearly 2.1 million children were living with HIV worldwide. With the current economic recession, children affected by HIV now need more help than ever.

International Adoption Rates Are Dropping

Although there is little data available on adoption of HIV-positive children, comparisons of overall international adoption numbers suggest rates are dropping.

According to the U.S. Department of State, the number of international adoptions into the U.S. has been decreasing steadily since 2004, with a total of 12,753 adoptions occurring in 2009 compared to a high of 22,990 in 2004.

From 2005 to 2009, the top four countries from which children were adopted were China, Russia, Guatemala, and Ethiopia, three of which have relatively low adult prevalence rates for HIV/AIDS. Ethiopia’s prevalence rate, the highest of the four at 2 percent, is still fairly low compared to many African nations.

In India, recent reports have claimed that adoption centers were unable to find families willing to adopt HIV-positive children, and as a result, no HIV-positive children were adopted in India from 2008 to 2009.

In 2009, a Moscow orphanage specializing in children of HIV-positive parents reported that it adopted out 31 children, many of them HIV-positive. However, this was down from a high of 49 children in 2007.

In many African countries, the number of AIDS orphans comprises at least half of the total number of orphans in the country. Such a large number of orphans has taken a heavy toll on communities, where traditional family structures to take care of orphans have broken down.

A study in Zambia in 2002 found that 63 percent of households surveyed were caring for orphans or children who were considered high-risk due to a parent’s illness or poverty. More than half of orphans had been separated from their siblings.

Without parents and a stable home, studies have shown that these children are more likely to suffer long term emotional consequences, such as depression, anxiety, and anger.

In addition, lack of parents to provide an income may drive young children to skip out on education and search for work instead, making them more vulnerable to exploitation and abuse.

International Adoption Of HIV-Positive Children

When Margaret Fleming formed Chances By Choice in 2003 to help place children with HIV with adoptive parents, many were skeptical of the idea.

To date, however, the organization has placed over 60 HIV-positive children with families. Fleming herself has adopted three HIV-positive children, both domestically and internationally, and has no regrets about the process (see related Beacon news).

Children with HIV, she said, are often easier to care for than children with diabetes.

With the lifting of the HIV travel ban (see related Beacon news), bringing HIV-positive children into the U.S. has become easier. Additionally, HIV-positive children are often considered special needs, so countries may ease regulations to facilitate their adoption.

Nonetheless, international adoptions can be long, expensive, and difficult.

International adoptions must comply with three different sets of laws: U.S. federal laws, the state laws of the adopting family, and the laws of the child’s country of birth.

Many countries have regulations about an adoptive parent’s age, marital status, and marriage length.

In Ethiopia, for example, couples usually must be married for at least 5 years prior to adopting, and there can usually be no more than a 40-year age difference between the adopting parents and the child. Gay or lesbian parents are not allowed to adopt in Ethiopia.

Certain requirements may be relaxed, however, for couples wanting to adopt children with HIV/AIDS. In Ethiopia, for example, single women may be allowed to adopt HIV-positive children.

Children with two HIV-positive parents, or only one living HIV-positive parent, are routinely considered orphans by the government of Ethiopia, which then becomes their legal guardian. Orphans are eligible for adoption after living at an orphanage for three months.

According to the Department of State, as of January of this year, “HIV infection is no longer an inadmissible condition [for entry into the U.S.], and HIV testing is no longer required for medical examinations for visa purposes.”

Since a special waiver is no longer necessary to bring an HIV-positive child into the U.S., a family wishing to adopt an HIV-positive child can complete the adoption in the same manner as any other international adoption.

The entire process usually takes one to four years, though it can take longer. Those wishing to adopt internationally must travel to the country for a period of time, ranging from a few days to several weeks.

The cost of an international adoption varies greatly; adoption services can cost as much as $30,000 per case.

For HIV-positive children, however, financial assistance may be available. For example, Promise Child Grants are currently available to parents adopting HIV-positive children age 2 years or older from Ethiopia. The grants provide $6,000 of financial assistance to eligible families.

The U.S. government also offers a tax credit for adoption of children, internationally or domestically. The credit, up to $13,170 per child for tax years 2010 and 2011, covers eligible out-of-pocket expenses for the adoption. Families who adopt a special needs child can claim the entire credit, even if their out-of-pocket expenses were less than the full credit amount.

Adoption Of HIV-Positive Children In The U.S.

For some people, making a difference in the lives of children with HIV starts closer to home. An estimated 200 children are born with HIV in the U.S. each year, and many more children enter the foster care system after losing parents to the virus.

When foster mother Lisa Bushman first met Olivia, she was three years old and HIV positive. At first, Bushman was not bothered by the fact that Olivia had HIV.

“I did think about it later,” she said. “I had a 13 month old little boy living with me at the time as well, and admittedly the first night she was in my home I had doubts.”

After researching the disease, however, Bushman recalls feeling relieved and excited at the prospect of having Olivia in her home.

She adopted Olivia by the time she was six years old.

Now an eight year old, Olivia takes a “cocktail” of three HIV medications every 12 hours. She also takes additional pills every 12 hours to control a seizure disorder she developed in 2008.

Other than that, “Olivia is by far my healthiest child of my three,” said her mother. “She is rarely sick, with an occasional cold or sore throat. We rarely have to go to her local pediatrician at all. It is quite ironic!”

Initially, as Bushman went through the process of adopting her three children, she used her blog, Little Did I Know, as a way to keep friends and family up to date on her experiences. Over time, she developed a community of supporters who were going through the same things she was.

As a summer project, she allowed Olivia to begin writing her own blog as well.

“I really didn’t guide her at all with what she wanted to name her blog (HIV – Heroes Inspiring Vision) or what she wanted to talk about on her blog, but I did know that she has some wonderful views of people and the world and hoped that maybe some of that would come through her writing. I thought this could be a great way for others to see that people with HIV are living and working and playing and creating and thriving among ‘us,’” said Bushman.

“I think she has been pleasantly surprised that so many people are interested in reading her words and watching her journey,” she added.

When Olivia was still her foster child, Bushman was not able to disclose Olivia’s HIV status to others. After becoming her mother, however, Bushman was faced with the tough decision of whether to tell others.

According to Bushman, “It wasn’t much of a decision. I never want Olivia to question who she is because of three little letters. As she says on her blog, ‘I’m just like everyone else, just with different blood.’ On the day of her adoption, I sent many letters to friends and family, feeling that was the best way to let everyone ‘in on it’ at once. We have been extremely blessed to have thus far received no negative responses from my letter.”

Through her blog and experiences with adopting an HIV-positive child, Bushman feels that more people are becoming open to adopting children with HIV. Although many still remember HIV for what it was in the 80s, Bushman hopes “millions more open their eyes to the very real picture of HIV, that of a thriving, beautiful, non-threatening eight-year-old girl.”

Resources On Adopting HIV-Positive Children

Many organizations exist throughout the U.S. that help parents adopt HIV-positive children.

Adoption-Link, an adoption agency located in Chicago, hosts a program entitled Chances by Choice that facilitates the domestic and international adoption of HIV-positive children.

Positively Orphaned, an online blog, features children waiting to be adopted. In addition, the website provides stories from families who have adopted children with HIV as well as links to information regarding HIV and adoption.

The Children’s Place, another organization located in Chicago, aids families and children affected by HIV by helping them find shelter, providing education and daycare services to young children, and providing counseling services to families. In addition, the Children’s Place has a foster care program and also facilitates the domestic adoption of HIV-positive children.

Positively Blessed is a blog written by a mother of two girls, one of whom is HIV positive and was adopted internationally. The blog details her experiences with adoption, as well as everyday life raising a child with HIV.

For more information on adoptions, please see the U.S. Department of State website or the Adoptions.com website. For information on the adoption tax credit, please see the IRS website.

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.