CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
maraviroc +2 moredrug
Likely dose
maraviroc 150 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/NCT00993148
NCT00993148Phase 2Completed
CompareCT.gov

Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile

Northwestern University·interventional·Posted Oct 12, 2009·Updated Sep 5, 2014

In Brief

A Phase 2 clinical trial evaluating maraviroc, darunavir, and 1 other intervention for HIV-1 Infection and HIV Infections. Completed, enrolled 25 participants across 5 sites.

Detailed Summary

The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection, HIV Infections
CountriesUnited States
CollaboratorsPfizer, Tibotec, Inc

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2009
Enrollment StartMay 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.7 years ago

Interventions

maravirocdrug

150 mg tab by mouth once daily for 96 weeks

darunavirdrug

800 mg tab by mouth once daily for 96 weeks

ritonavirdrug

100 mg capsule by mouth once daily for 96 weeks