WAVES: Women’s AntiretroViral Efficacy and Safety Study
Research type
Research Study
Full title
A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Infected, Antiretroviral Treatment-Naïve Women
IRAS ID
116975
Contact name
Margaret Johnson
Sponsor organisation
Gilead Sciences Incorporated
Eudract number
2012-003708-11
Clinicaltrials.gov Identifier
Research summary
Approximately 34 million people are HIV-infected worldwide. Women are the fastest growing group of infected people but remain under-represented in clinical studies. Gilead Sciences Inc. is conducting this women-only study to help understand more about the gender specific safety and effectiveness of a new combination pill containing a combination of four drugs (EVG/COBI/FTC/TDF). Two of these drugs, Elvitegravir (EVG) and Cobicistat (COBI), are not yet approved in the UK. The other two drugs, Emtriva (FTC) and Viread (TDF) are approved. The EVG/COBI/FTC/TDF combination pill has been approved for use in the US, and has been submitted but is not yet approved for use in Europe. The EVG/COBI/FTC/TDF combination pill may be an alternative fixed-dose treatment for female patients of childbearing potential because of concerns about possible birth defects with a component of the existing fixed dose treatment (Atripla). This study will compare the EVG/COBI/FTC/TDF combination pill to Ritonavir (RTV) and Atazanavir (ATV) when taken with Truvada (FTC/TDF), which are all approved HIV treatments in the UK. 510 patients from about 50 sites worldwide will take part. Patients will be assigned to one of 2 treatment arms; they will not know which treatment they are receiving: Arm 1: EVG/COBI/FTC/TDF combination ritonavir placebo Atazanavir placebo Truvada placebo Arm 2: EVG/COBI/FTC/TDF combination placebo Ritonavir Atazanavir Truvada Study procedures will include physical examinations, laboratory tests, questionnaires about HIV symptoms, treatment, and side effects experienced. A 35 day screening period is followed by a 48 week treatment period. There are 10 study visits during this time. After Week 48, there will be visits every 12 weeks until the last patient in the study reaches week 48, after this time there will be a 30 day follow-up visit.
REC name
London - Central Research Ethics Committee
REC reference
12/LO/1823
Date of REC Opinion
24 Jan 2013
REC opinion
Further Information Favourable Opinion