CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 558 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/NCT00931463
NCT00931463Phase 4Completed
CompareCT.gov

A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy

Kirby Institute·interventional·Posted Jul 2, 2009·Updated Mar 27, 2026

In Brief

A Phase 4 clinical trial evaluating raltegravir, 2N(t)RTI, and 1 other intervention for HIV Infections. Completed, enrolled 558 participants across 44 sites in 17 countries.

Detailed Summary

The investigators hypothesize that following virological failure of a standard NNRTI+2N(T)RTI regimen second-line antiretroviral therapy consisting of ritonavir-boosted lopinavir and 2N(T)RTIs will offer comparable efficacy to that provided by ritonavir-boosted lopinavir and raltegravir. The study will be conducted for 96-weeks with the primary endpoint analyzed after 48-weeks. The primary endpoint is virological: a comparison of virological suppression in plasma \< 200 copies/mL between the randomized arms after 48 weeks. Secondary and exploratory endpoints include virological, immunological, safety, clinical, metabolic, drug adherence, drug resistance and quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Australia, Chile, France, Germany, Hong Kong, India, Ireland, Malaysia, Mexico, New Zealand, Nigeria, Peru, Singapore, South Africa, Taiwan, United Kingdom
CollaboratorsMerck Sharp & Dohme LLC, Abbott, amfAR, The Foundation for AIDS Research

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2009
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17 years ago

Interventions

raltegravirdrug

400 mg raltegravir tablet taken every 12 hours

2N(t)RTIdrug

2N(t)RTIs as prescribed

Ritonavir-boosted lopinavirdrug

2 heat-stable tablets of ritonavir-boosted lopinavir taken every 12 hours