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-Na?ve Adults - ND

• Conditions: HIV-1 infection; MedDRA version: 12.1Level: LLTClassification code 10020192Term: HIV-1

• Registration Number: EUCTR2009-016759-22-IT
• Lead Sponsor: Gilead Sciences Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-10
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

HIV-1 Subjects who meet the following critria:
• Plasma HIV-1 RNA levels = 5,000 copies/mL at screening
• No prior use of any approved or investigational antiretroviral drug for any length of time
• Screening genotype report provided by Gilead Sciences must show sensitivity to FTC, TDF and ATV.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A new AIDS-defining condition diagnosed within the 30 days prior to screening • Subjects receiving drug treatment for Hepatitis C • Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified