MedTrace Logo

Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)

NCT02519777 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2022-04-22

Study results available
· View outcomes & findings →

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.

Conditions

  • HIV Infections

Interventions

DRUG

Placebo for maraviroc (MVC)

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

DRUG

Placebo for dolutegravir (DTG)

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

DRUG

Dolutegravir (DTG)

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

DRUG

Maraviroc (MVC)

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kevin Robertson, PhD · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-21
Primary Completion
2019-12-02
Completion
2021-01-05
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Puerto Rico
  • South Africa
  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02519777 on ClinicalTrials.gov