CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 191 enrolled
Drug / intervention
Placebo for maraviroc (MVC) +3 moredrug
Likely dose
Placebo for maraviroc (MVC) 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/NCT02519777
NCT02519777Phase 4Completed

A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification With Maraviroc and Dolutegravir With No Intensification or Intensification With Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 11, 2015·Updated Apr 22, 2022

In Brief

A Phase 4 clinical trial evaluating Placebo for maraviroc (MVC), Placebo for dolutegravir (DTG), and 2 other interventions for HIV Infections. Completed, enrolled 191 participants across 30 sites in 5 countries.

Detailed Summary

People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The study evaluated if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral \[ARV\] medications) to participants' existing ART regimens improved participants' neurocognitive performance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, Puerto Rico, South Africa, Thailand, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 11, 2015
Enrollment StartApr 21, 2016
Primary CompletionDec 2, 2019
Study CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.9 years ago

Interventions

Placebo for maraviroc (MVC)drug

Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen

Placebo for dolutegravir (DTG)drug

Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen

Dolutegravir (DTG)drug

Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen

Maraviroc (MVC)drug

Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen