CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Raltegravir +2 moredrug
Likely dose
Raltegravir 400 mgfrom 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/NCT00814879
NCT00814879N/ACompleted
CompareCT.gov

A Pilot Randomized, Open-Label Study Comparing the Safety and Efficacy of a Raltegravir Based NRTI Sparing Regimen

Yale University·interventional·Posted Dec 25, 2008·Updated Feb 4, 2016

In Brief

A clinical study evaluating Raltegravir, Atazanavir, and 1 other intervention for Acquired Immune Deficiency Syndrome and 3 related conditions. Completed, enrolled 60 participants across 5 sites.

Detailed Summary

This pilot study will provide data on the safety and efficacy of the combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects that have a suppressed HIV viral load on a Ritonavir (RTV) boosted Protease Inhibitor (PI) based regimen who are then switched to a regimen of RAL 400mg BID +ATV 300mg BID.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Immune Deficiency Syndrome, AIDS, Human Immunodeficiency Virus, HIV Infections
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Merck Sharp & Dohme LLC

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2008
Enrollment StartMay 1, 2009
Primary CompletionMay 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.5 years ago

Interventions

Raltegravirdrug

400 mg BID

Atazanavirdrug

300 mg BID

Standard treatment regimenother

N(t)RTI(s) based backbone plus ritonavir boosted PI