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A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir (ATV/GS-9350) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Southwest Center for HIV/AIDS
Phoenix, Arizona, United States
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States
AIDS Healthcare Foundation-Research Center
Beverly Hills, California, United States
The Living Hope Foundation
Long Beach, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
David J. Shamblaw, MD Inc.
San Diego, California, United States
Metropolis Medical
San Francisco, California, United States
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Start Date
May 1, 2009
Primary Completion Date
December 1, 2009
Completion Date
January 1, 2015
Last Updated
February 15, 2016
85
ACTUAL participants
COBI
DRUG
RTV
DRUG
ATV
DRUG
FTC/TDF
DRUG
COBI placebo
DRUG
RTV placebo
DRUG
Lead Sponsor
Gilead Sciences
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06902038