Conditions: HIV-1 Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 262
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD arm 2: Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD

Interventions: intervention 1: Darunavir intervention 2: Ritonavir intervention 3: Tenofovir disoproxil fumarate intervention 4: Emtricitabine intervention 5: Placebo for Tenofovir disoproxil fumarate intervention 6: Placebo for Maraviroc intervention 7: Maraviroc
Intervention descriptions: intervention 1: 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. intervention 2: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. intervention 3: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. intervention 4: Emtricitabine was administered orally once a day as one 200 mg capsule. intervention 5: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. intervention 6: Placebo for maraviroc was administered orally once a day as one tablet. intervention 7: Maraviroc was administered orally once a day as one 150 mg tablet.

Protocol document: