At a glance
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A Phase 2b, Double-Blind, Placebo-Controlled, Exploratory Randomized Trial to Determine the Bone, Immunologic, Virologic, and Neurocognitive Effects of a Novel Maraviroc-Containing Antiretroviral Regimen in Treatment-Naïve Patients Infected With R5-Tropic HIV-1
In Brief
A Phase 2 clinical trial evaluating Darunavir, Ritonavir, and 5 other interventions for HIV-1 Infection. Completed, enrolled 262 participants across 38 sites in 2 countries.
Detailed Summary
The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the following: * To see how the drug combinations affect the brain and kidneys. * To see how well the drug combinations lower the HIV viral load. * To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs.
Study Details
Timeline
Interventions
Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
Emtricitabine was administered orally once a day as one 200 mg capsule.
Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.
Placebo for maraviroc was administered orally once a day as one tablet.
Maraviroc was administered orally once a day as one 150 mg tablet.