NCT01400412

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There are now several HIV treatment options for a person with HIV infection who has not yet been treated. Most people who receive treatment and take their medications as directed have a good result. This is usually determined by measuring the amount of HIV in the blood (viral load). The best response is when HIV cannot be found (less than 50 copies/mL) in the blood. However, it has recently become clear that some people with HIV who are receiving effective HIV drugs continue to have more health problems than people without HIV infection. Sometimes, there is damage to organs in the body, including bone, kidneys, and the brain.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Darunavir	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.
DRUG	Ritonavir	Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
DRUG	Tenofovir disoproxil fumarate	Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
DRUG	Emtricitabine	Emtricitabine was administered orally once a day as one 200 mg capsule.
DRUG	Placebo for Tenofovir disoproxil fumarate	Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.
DRUG	Placebo for Maraviroc	Placebo for maraviroc was administered orally once a day as one tablet.
DRUG	Maraviroc	Maraviroc was administered orally once a day as one 150 mg tablet.

Timeline

• Start date: 2012-01-17
• Primary completion: 2014-06-30
• Completion: 2014-06-30
• First posted: 2011-07-22
• Last updated: 2024-10-15
• Results posted: 2015-07-15

Locations

38 sites across 2 countries: United States, Puerto Rico