Articles tagged with: Clinical Trial
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Panel members debated the pros and cons of starting early Highly Active Antiretroviral Therapy (HAART) in a discussion last week at the International AIDS Conference in Vienna, Austria.
Previous guidelines advised patients to begin HAART after the onset of AIDS symptoms or when their CD4 (white blood cell) count dropped below 200 cells per milliliter.
In 2009, however, the World Health Organization released new guidelines recommending that treatment start when CD4 counts drop to 350 cells per milliliter. Proponents argued that this number better protects patients from long-term immune system…
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Researchers presented results of five studies involving new HIV treatment regimens yesterday as part of the 2010 International AIDS Conference in Vienna, Austria. Three of the studies involved simplified treatments meant to reduce side effects, and the other two studies presented clinical trial results for potential new antiretrovirals.
The studies, which yielded mostly positive results, illustrate the growing variety of treatment and medication options for people with HIV.
The three studies involving new treatment regimens all use Isentress (raltegravir), an integrase inhibitor approved by the United States Food and Drug…
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A study published last week in AIDS Patient Care and STDs found that Trizivir (zidovudine/lamivudine/abacavir) may help people with HIV simplify their long-term maintenance antiretroviral therapy (ART) routine, decreasing harmful side effects and making the drug regimen easier to follow.
However, the study authors caution that their results, which include only 48 weeks of trial data, are still preliminary. Longer follow-up periods will be necessary to ensure the regimen will be safe and effective long-term.
Currently, the standard treatment regimen for HIV includes at least three antiretroviral medications from two…
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Clinical trials for several types of therapeutic HIV vaccines are currently ongoing or recruiting participants.
Therapeutic HIV vaccines work by enhancing the body’s natural immune response, helping to control HIV in people already infected with the virus.
This is in contrast to preventative vaccines, which are used in HIV-negative individuals to prevent infection.
Researchers hope therapeutic vaccines will decrease dependence on antiretroviral drugs, which must be taken for life and often have serious side effects.
“A vaccine that enhanced the body’s ability to control HIV and delayed or decreased the…
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A study published this week in Science Translational Medicine showed that genetically modified blood stem cells transplanted into HIV patients successfully produced antiviral material, which could theoretically suppress the virus long-term without antiretroviral drugs.
However, the amounts were too low to actually show anti-HIV activity.
Scientists believe that stem cell-based gene therapy is a promising prospect to eventually replace highly active antiretroviral therapy (HAART) (see related AIDS Beacon news).
“We hope to provide patients with long term protection from immunodeficiency and free them from a life long dependence on…
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An article published last week in PLoS Pathogens argues that combining antiretroviral therapy with a short course of immunotoxins, which are used in certain types of chemotherapy, could suppress HIV levels to the point that antiretrovirals are no longer needed long-term.
“Ultimately, immunotoxins will be of value in HIV treatment only if they can enable patients to stop HAART for prolonged periods, sufficient to provide a meaningful quality of life benefit,” wrote the authors.
Although still preliminary, the authors believe the idea is promising enough that it should be tested…
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Myriad Pharmaceuticals announced last week that it will suspend further development of its anti-HIV drug, MPC-4326, and will instead focus on developing anti-cancer drugs. The company attributed the change to strategic and business reasons.
Patrick Burke, Vice President of Corporate and Business Development at Myriad Pharmaceuticals, stated in an interview with The AIDS Beacon that Myriad is currently looking for a partner to advance MPC-4326 and an additional novel HIV drug. This partner would then acquire rights to advance the drugs further.
Myriad’s Phase 2 clinical trial into the efficacy…
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Gilead Sciences has officially announced the start of a new Phase 3 clinical trial program investigating the fixed dose, single tablet “Quad” regimen.
The “Quad” regimen includes elvitegravir, cobicistat (GS 9350), Emtriva (emtricitabine), and Viread (tenofovir). Quad therapy combines different drugs into a single pill, which makes adherence to a therapeutic regimen easier for HIV patients.
“Efficacy and safety results from the Phase 2 study suggest that the Quad may represent an important new option for patients with HIV,” said Dr. Norbert Bischofberger, Executive Vice President of Research and Development…
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Tesamorelin, a growth hormone-releasing compound, successfully reduced abdominal fat in HIV-positive subjects by approximately 18 percent, according to a new study published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).
Excess abdominal fat accumulation, also called lipohypertrophy, is one of the potential side effects of antiretroviral therapy (ART). Tesamorelin, a new drug candidate, may be able to counteract this common problem among HIV patients.
The clinical trial took place over 12 months among 404 HIV-positive individuals with excess abdominal fat as a result of ART. Some patients were given…
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Results from a large international clinical trial on an HIV preventative gel, PRO 2000, show no evidence that it decreases the risk of HIV infection in women.
This has been a disappointing finding for researchers and has likely brought an end to further research in this particular product.
PR0 2000 is a vaginal microbicide, which is a substance whose purpose is to reduce the infectivity of viruses. As of now, there are no microbicides that have been effective against HIV infection.
PRO 2000 is designed to be used by women…