CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
atazanavir/raltegravir +2 moredrug
Likely dose
atazanavir/raltegravir 100mgfrom 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/NCT00931801
NCT00931801Phase 4Completed
CompareCT.gov

A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine

Community Research Initiative of New England·interventional·Posted Jul 2, 2009·Updated Jul 21, 2017

In Brief

A Phase 4 clinical trial evaluating atazanavir/raltegravir and atazanavir/tenofovir/emtricitabine for HIV. Completed, enrolled 43 participants across 9 sites.

Detailed Summary

The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Merck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2009
Enrollment StartDec 1, 2009
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17 years ago

Interventions

atazanavir/raltegravirdrug

Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily

atazanavir/raltegravirdrug

Atazanavir 300mg twice daily plus raltegravir 400mg twice daily

atazanavir/tenofovir/emtricitabinedrug

Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine