CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 515 enrolled
Drug / intervention
Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) +1 moredrug
Likely dose
Not stated in 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/NCT00440947
NCT00440947Phase 3Completed
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See Detailed Description

ViiV Healthcare·interventional·Posted Feb 27, 2007·Updated Mar 22, 2012

In Brief

A Phase 3 clinical trial evaluating Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) and Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) for Infection, Human Immunodeficiency Virus I and HIV Infection. Completed, enrolled 515 participants across 72 sites in 3 countries.

Detailed Summary

This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B\*5701 negative subjects. All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus I, HIV Infection
CountriesCanada, Puerto Rico, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 27, 2007
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.3 years ago

Interventions

Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)drug

Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV)+ ritoanvir (/r) for 36weeks followed by ABC/3TC + ATV + /r for 48wks followed by optional treatment extension for 60 weeks on the same regimen

Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)drug

Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV) + ritonavir (/r) for 36 weeks followed by ABC/3TC + ATV for 48wks followed by optional treatment extension for 60 weeks on the same regimen