GS 0114 GS-9350 study in treatment-naive HIV patients

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS 9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Adults.

• IRAS ID

  49761

• Contact name

  Graeme Moyle

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2009-016759-22

• Clinicaltrials.gov Identifier

  tba

• Research summary

  With an estimated 33.2 million people infected worldwide, HIV is a major medical problem. This clinical research study involves an experimental medicine called GS-9350 (cobicistat) for the treatment of HIV1. GS-9350 is being developed as a ??booster? for the antiviral drug called atazanavir. A ??booster? helps the drug stay in the body longer. The purpose of this study is to see if GS-9350 when given in combination with atazanavir and Truvada© is safe and effective in reducing levels of HIV-1 in the blood of patients who are treatment-naive. To date 335 healthy participants and 50 HIV-infected, treatment naive participants have taken GS-9350 in clinical trials. The safety and effectiveness of GS-9350 will be compared to a similar ??booster? drug called ritonavir. Ritonavir and atazanavir are known as protease inhibitors, and when given together, ritonavir boosts atazanavir. Ritonavir, atazanavir and Truvada are approved drugs. The safety and effectiveness of GS-9350 will be measured by physical examinations, laboratory tests and adverse events. Blood HIV-1 as well as drug levels will be measured at various times during the study. This is a double-blind study; participants have a 50% chance of receiving either GS-9350 or ritonavir, plus atazanavir and Truvada. Study duration is 96 weeks in the randomized, double-blind phase. After which, participants will continue to take their blinded study drug until treatment has been unblended, when all participants will have the option to enter an open-label, rollover study. After screening, study visits will be at Weeks 2, 4, 8, 12, 16, then every 8 weeks until Week 48, then every 12 weeks until Week 96. 700 participants will recruited from about 210 study sites Worldwide. The Sponsor is Gilead Sciences, Inc.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/34

• Date of REC Opinion

  11 May 2010

• REC opinion

  Further Information Favourable Opinion