Articles tagged with: Clinical Trial
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Results released today from two new African clinical trials show that the anti-HIV drugs Viread and Truvada are effective at preventing transmission of HIV in heterosexual couples when combined with regular condom use and other traditional prevention measures.
When taken daily, the antiretrovirals reduced transmission risk by 60 percent to 70 percent. Due to the strength of the results one of the two trials was modified to discontinue the placebo group early, with all participants being placed on the drugs for prevention purposes.
“These are exciting results for global HIV…
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Texas AIDS Drug Assistance Program Faces Budget Shortfall – The Texas AIDS Drug Assistance Program has failed to secure additional funding and will face budget shortages starting in September 2012. State officials have said that they will likely implement cost-cutting measures, such as excluding more expensive HIV drugs and asking pharmaceutical companies for discounts, to mitigate the shortages. The Texas legislature had previously decided not to give the program an additional $19 million to prevent cutbacks (see related AIDS Beacon news), instead deciding that the program could receive additional funds from the state’s Medicaid budget if needed. However, Medicaid also faces a $4.8 billion shortfall, making such assistance unlikely. For more information, please see the Associated Press article.
GeoVax Adds Los Angeles Site To Phase 1 Trial Of Therapeutic HIV Vaccine – Biotechnology company GeoVax Labs has announced that it is adding a third location, in Los Angeles, to its Phase 1 trial of a therapeutic vaccine to treat HIV. The first two sites are in Atlanta and Birmingham, AL. The trial is testing the safety and efficacy of the vaccine in controlling HIV replication in people already infected with the virus; participants will stop taking antiretrovirals for 12 weeks as part of the trial. GeoVax expects to enroll 10 participants. For more information, please see the GeoVax press release or the U.S. Clinical Trials Registry.
Tibotec Therapeutics Changes Name To Janssen Therapeutics – Tibotec Therapeutics, the maker of the HIV drugs Prezista (darunavir), Intelence (etravirine), and Edurant (rilpivirine), has changed its name to Janssen Therapeutics. The name change is an attempt to create a common link between all of the Janssen companies, which are subsidiaries of Johnson & Johnson and include Janssen Pharmaceuticals and Janssen Biotech. The company’s new website includes links to information on its antiretrovirals and patient assistance programs to help low-income patients pay for the drugs. For more information, please see the Johnson & Johnson press release or the Janssen Therapeutics website.
Reminder: Free HIV Testing Today – As part of National HIV Testing day, many locations nationwide will offer free HIV testing today (see related AIDS Beacon news). To find a testing location, please see the Centers for Disease Control’s National HIV Testing Day website.
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Washington, D.C. Still Has The Highest Rate Of HIV And AIDS In The U.S. – A report released last week by the District of Columbia Department of Health states that D.C. still has the highest rate of HIV in the country, with more than 3 percent of the population over the age of 12 testing positive. The report does note that the number of new cases reported has dropped almost 50 percent in the last two years, but health officials stated that part of the drop may be due to a newer, more accurate method for counting new cases. The disease continues to affect primarily African Americans and adults aged 30 to 59. For more information, please see the District of Columbia Annual Report 2010 or the Washington Post article.
Theratechnologies Applies For Approval Of Egrifta In Canada – Theratechnologies has applied for approval of Egrifta (tesamorelin) from the Therapeutic Products Directorate of Health Canada. If approved, Egrifta will be the first drug in Canada to treat lipodystrophy, a condition of abnormal fat distribution that is a side effect of certain anti-HIV medications. Based on average approval times for Health Canada, a decision would be expected late next year. Theratechnologies applied for approval of Egrifta in Europe earlier this month via its partner Ferrer Internacional S.A., and the drug was approved in the U.S. in November of last year. For more information, please see the Theratechnologies press release.
June 27 Marks National HIV Testing Day – This year, June 27 will mark the 17th annual National HIV Testing Day. The day is organized by the National Association of People With AIDS (NAPWA), and its purpose is to publicize and promote regular HIV testing, particularly in at-risk populations such as African Americans and men who have sex with men. Communities and health centers will be offering HIV testing nationwide, in many cases free of charge. For more information or to find a local testing center, please see NAPWA’s National HIV Testing Day website.
Salix Pharmaceuticals Recruiting HIV-Positive Participants For Phase 3 Trial Of Diarrhea Drug – Salix Pharmaceuticals, a small pharmaceutical company based in North Carolina, is currently recruiting HIV-positive participants for a Phase 3 clinical trial of its investigational anti-diarrhea drug crofelemer. Participants must be on antiretroviral therapy and have had HIV-associated diarrhea for at least four weeks. Crofelemer successfully completed a Phase 3 clinical trial in people with HIV in November of last year in which three dosages (125 mg, 250 mg, and 500 mg daily) were tested; this new trial will test the safety and tolerability of a 125 mg dose twice daily. Salix is currently recruiting participants at locations in Arizona, Arkansas, California, Florida, and Georgia and expects to add additional locations at a later date. For more information, please see the U.S. Clinical Trials Registry.
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This article is the fourth in a four-part series that investigates current research toward finding a cure for HIV, including advances, promising treatment strategies, and barriers to reaching a cure. Part 1 discusses general types of HIV cures. Part 2 discusses specific strategies for targeting latent HIV. Part 3 discusses gene therapy and therapeutic vaccines. Part 4 discusses barriers to obtaining a cure.
Although researchers are getting closer to finding a cure for HIV and have a number of promising avenues to pursue, there are still a…
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Roche Updates Fuzeon Prescribing Information To Warn Of Increased Pneumonia Risk – Roche updated the prescribing information for Fuzeon (enfuvirtide) last week to include information on a possible increased risk of bacterial pneumonia. Results from a recent study showed that patients taking Fuzeon were at about a 30 percent higher risk of contracting pneumonia. Although Roche is not certain that the higher rate is due to Fuzeon treatment, the company recommends that patients taking the drug be carefully monitored for signs of pneumonia. For more information, please see the FDA website.
Abbott Agrees To Cut Kaletra Drug Price For ADAPs – Abbott Laboratories announced last week that it has agreed to cut the price of its protease inhibitor Kaletra (lopinavir/ritonavir) for government-funded AIDS Drug Assistance Programs (ADAPs). Abbott will reduce the price of Kaletra by 8 percent to $5,037 per patient per year. ADAPs provide antiretroviral drugs to low-income people with HIV who cannot afford their medications. Due to the recession, many state ADAPs have been faced with budget cutbacks and increasing enrollment. According to the National Alliance of State and Territorial AIDS Directors, as of April 22, there were 7,674 people on ADAP waiting lists nationwide. For more information, please see the article in the Chicago Tribune.
Federal Judge Orders New York City To Restore AIDS Funding – A federal judge has ruled against a plan by New York City to cut funding for the city’s HIV/AIDS Service Administration (HASA). The proposed cuts would have eliminated 254 case managers from HASA’s staff. The judge ruled that the cuts violated New York City Local Law 49 and a federal court order that require HASA to maintain a case manager to client ratio of 1 to 34. The judge informed lawyers representing the city that they have 30 days to show that the budget cuts to HASA will not occur. For more information, please see the Housing Works press release.
Tobira Therapeutics Recruits Participants For Phase 2 Clinical Trial For CCR5 Inhibitor Cenicriviroc – Pharmaceutical company Tobira Therapeutics is currently recruiting participants to study the effectiveness, safety, and tolerability of its investigational CCR5 inhibitor cenicriviroc (TBR-652). Currently the only CCR5 inhibitor approved by the U.S. Food and Drug Administration is Selzentry (maraviroc). Participants will receive cenicriviroc plus Truvada (tenofovir/emtricitabine) or Sustiva (efavirenz) plus Truvada. The study is recruiting approximately 150 previously untreated HIV-positive adults. Trial locations include sites in Arizona, Florida, New York, and New Jersey. For more information, please see the U.S. Clinical Trials Registry.