At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 297 enrolled

Drug / intervention

Reyataz + Norvir + Truvada +1 moredrug

Likely dose

Reyataz + Norvir + Truvada 300mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01102972

NCT01102972Phase 4Completed

Compare CT.gov

A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, HIV-1 Infected, HLA-B*5701 Negative Subjects

ViiV Healthcare·interventional·Posted Apr 13, 2010·Updated Nov 19, 2013

In Brief

A Phase 4 clinical trial evaluating Reyataz + Norvir + Truvada and Reyataz + Epzicom for Infection, Human Immunodeficiency Virus. Completed, enrolled 297 participants across 46 sites in 2 countries.

Detailed Summary

This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects for 48 weeks.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfection, Human Immunodeficiency Virus

CountriesPuerto Rico, United States

CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartApr 2010

First PostedApr 2010

Primary CompletionJun 2012

Study CompletionDec 2012

TodayJul 2026

First PostedApr 13, 2010

Enrollment StartApr 1, 2010

Primary CompletionJun 1, 2012

Study CompletionDec 1, 2012

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 16.2 years ago

Interventions

Reyataz + Norvir + Truvadadrug

atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg

Reyataz + Epzicomdrug

atazanavir 400mg + abacavir 600mg/lamivudine 300mg