GS 0103 Quad study in treatment-naïve HIV patients

• Research type

  Research Study

• Full title

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

• IRAS ID

  43213

• Contact name

  Brian Gazzard

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2009-016758-42

• Clinicaltrials.gov Identifier

  tba

• Research summary

  HIV is a major, global medical problem. Guidelines recommend three drugs from two classes for initial HIV treatment: two nucleosides (NRTI) with non-nucleoside (NNRTI) or boosted protease inhibitor (PI). Recent guidelines include a new class, integrase inhibitors (INSTI); raltegravir, the only currently licensed INSTI, is a preferred or alternative option in Europe and the US. Side effects are the main reason for changing or failing therapy and new, simple, safe and effective treatments are required. This trial compares an investigational single tablet regimen with a recommended and approved first-line option of Truvada (a fixed dose two NRTI pill containing tenofovir and emtricitabine) plus the PI atazanavir plus the boosting agent ritonavir (3 pills) for the treatment of HIV-1. The new product contains the same two NRTI plus an investigational INSTI (elvitegravir) with investigational booster (GS9350). Elvitegravir, like PI, requires boosting; GS9350 has been developed as an alternative to the booster ritonavir which causes lipid abnormalities and interacts with other drugs. This study aims to investigate the safety and effectiveness of EVG/FTC/TDF/GS9350 in untreated HIV-1 infected patients by comparing treatment responses (suppression of HIV in blood and improvements in the immune system) and side effects/laboratory abnormalities with Truvada©/atazanavir/ritonavir. The study is double-blind and patients will have a 50:50 chance of being allocated either treatment. Visits are at screening, baseline, weeks 2, 4, 8, 12, 16 then 8-weekly till week 48 and then 12-weekly till week 96; after this all patients wil have the option to enter an unblinded extension. The aim is to recruit 700 patients from 210 Worldwide sites and the sponsor is Gilead Sciences Inc who make Truvada and the new combined pill. To date 122 healthy participants and 48 HIV-infected, treatment-naive participants have taken the EVG/FTC/TDF/GS9350 fixed dose combination tablet in clinical trials.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/33

• Date of REC Opinion

  11 May 2010

• REC opinion

  Further Information Favourable Opinion