CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7 enrolled
Drug / intervention
Switch to Maraviroc + Raltegravir or Dolutegravirdrug
Likely dose
Not stated in 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/NCT01896921
NCT01896921Phase 3Completed

Switch to Maraviroc and Integrase Strand Transfer Inhibitor Combination Therapy (a Triple Class-Sparing Regimen) for the Treatment of HIV-1-Infected Patients on Suppressive Antiretroviral Regimens

University of Maryland, Baltimore·interventional·Posted Jul 11, 2013·Updated Oct 20, 2021

In Brief

A Phase 3 clinical trial evaluating Switch to Maraviroc + Raltegravir or Dolutegravir for HIV. Completed, enrolled 7 participants across 1 site.

Detailed Summary

This clinical study proposes to evaluate the combination of maraviroc with an integrase strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced patients to document the efficacy, safety, and tolerability of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART regimen which lessens the risk of metabolic complications could improve long-term adherence and reduce the risk of certain co-morbidities associated with long-term ART use. If this new combination is found to be as efficacious as the standard regimen with enhanced tolerability and improved metabolic effects, there is great potential for altering the current practice of HIV medicine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartSep 1, 2013
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 13.0 years ago

Interventions

Switch to Maraviroc + Raltegravir or Dolutegravirdrug

Change HIV-infected patients on stable, suppressed ART regimens for at least 1 year to experimental regimen of Maraviroc + Raltegravir or Dolutegravir for 48 weeks