CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 132 enrolled
Drug / intervention
Atazanavir +3 moredrug
Likely dose
Atazanavir 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/NCT01332227
NCT01332227Phase 4Completed

An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

Bristol-Myers Squibb·interventional·Posted Apr 11, 2011·Updated Feb 19, 2015

In Brief

A Phase 4 clinical trial evaluating Atazanavir, Ritonavir (heat-stable), and 2 other interventions for HIV, Combination Therapy. Completed, enrolled 132 participants across 38 sites in 7 countries.

Detailed Summary

The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Italy, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2011
Enrollment StartOct 1, 2011
Primary CompletionSep 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.2 years ago

Interventions

Atazanavirdrug

Capsules, Oral, 300mg, Once daily, 48 weeks

Ritonavir (heat-stable)drug

Tablets, Oral, 100 mg, Once daily, 48 weeks

Raltegravirdrug

Tablets, Oral, 400 mg, Twice daily, 48 weeks

Tenofovir/Emtricitabinedrug

Tablets, Oral, 300/200 mg, Once daily, 48 weeks