Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

HIV-1 Infection Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HIV-1 Infection

• NCT number: NCT01400412
• Study type: Interventional
• Source: AIDS Clinical Trials Group
• Status: Completed
• Phase: Phase 2
• Start date: January 17, 2012
• Completion date: June 2014