At a glance
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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
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
Timeline
Interventions
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
Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen
Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen
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