GS 0118 Open label cobicistat regimens in HIV
Research type
Research Study
Full title
A Phase 3, Open-label Safety study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients with Mild to Moderate Renal Impairment
IRAS ID
80039
Contact name
Martin Fisher
Contact email
Sponsor organisation
Gilead Sciences Inc
Eudract number
2011-000488-29
Duration of Study in the UK
1 years, 4 months, 29 days
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 open label trial will recruit participants with HIV who have mild to moderate renal impairment (kidney function problems).
In this trial, participants who are treatment naïve (received no prior anti-HIV medication) will receive an investigational single tablet regimen (EVG/COBI/FTC/TDF). This combination tablet contains 2 experimental drugs (EVG and COBI). EVG is an integrase inhibitor, which requires boosting; COBI is being developed as an alternative booster to ritonavir which is known to cause lipid abnormalities and interact with other drugs. FTC and TDF (NRTIs) are both licensed for the treatment of HIV.
Participants currently taking ritonavir along with either atazanavir or darunavir plus 2 NRTIs will switch to take one experimental medication (COBI) combined with either atazanavir or darunavir and two NRTIs.
The purpose of this study is to see if either the combination pill EVG/COBI/FTC/TDF or the combination of COBI with atazanavir or darunavir and 2 two NRTIs is safe and effective in reducing blood levels of HIV-1 in patients with renal impairment.
The safety and how well these drug combinations are tolerated will be measured by physical examinations, laboratory tests and adverse events.
The trial requires 13 clinic visits over approximately 20 months, including the screening and follow-up period. The treatment period is 48 weeks. The aim is to recruit 100 patients from approximately 100 sites worldwide. The sponsor is Gilead Sciences Inc.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
11/LO/0751
Date of REC Opinion
2 Aug 2011
REC opinion
Further Information Favourable Opinion