Contact: Max Menna (202) 444-0371
GSK “ARIA” ING117172: This is a 48 week Phase IIIb, randomized, open-label study of the safety and efficacy of the single tablet regimen of dolutegravir/abacavir/lamuvidine once daily compared to atazanavir and ritonavir administered with the fixed dose combination tablet of tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve adult women.
ACTG 5308: This 60-108 week study is being done with people who are infected with HIV, but do not show any signs of having HIV, and are doing well without taking HIV medication. The purpose of this study is to see if taking HIV medication (antiretroviral therapy [ART]) will reduce immune activation (the body’s way of fighting disease) in people who have HIV, but do not show symptoms. This constant immune activation may be harmful and lead to premature aging or conditions such as heart disease. Also this study will help determine how safe the drug is and how well the body reacts to the drug. Volunteers must be 18 years of age or older and have an HIV-1 viral load of less than 500 copies for a period of at least 24 months. Volunteers cannot have taken antiretroviral (anti-HIV) medications in the past. Participants will be provided Complera during the study.
START: This study is being done to see when is the best time to START taking anti-HIV medications; either when the CD4 cell count is high or wait until it decreases. All participants are randomly assigned into one of two groups:
1). START anti-HIV medications immediately or 2). Wait to START until the CD4 cell count is <350. To be eligible for START, participants must have a CD4 T-cell count of more than 500, and have not yet taken HIV medications. All study-related costs and medications are provided throughout the study. All START participants stay in their assigned groups for the duration of the study, which is expected to be about 5 years.
GS-US-337-0123: Is a 40-52 week, Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant.
Merck 5172: Is a Phase II Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination with Ribavirin in Subjects with Chronic Hepatitis C Virus Infection.
HIV and Hepatitis C
ACTG 5294: This study is being done to see if adding the new drug, boceprevir to the standard combination of pegylated-interferon alfa 2b plus ribaviran is safe and whether it will help people with both HIV and HCV better fight their HCV. The third drug, Boceprivir, has already been approved by the Food and Drug Administration (FDA) recently for the treatment of people who are infected with HCV alone. Study drugs will be pegylated-interferon alfa 2b given as a weekly injection (under the skin), ribavirin based on weight (taken twice daily by mouth), and boceprevir (taken three times daily by mouth). All participants (both HCV treatment naïve [individuals who have never taken HCV medications] and treatment experienced [individuals who have previously taken HCV medications]) will be evaluated for a sustained virologic response (SVR) (undetectable HCV RNA levels found in the blood) 24 weeks after the end of treatment. You will be in this study for about 72-weeks.