Conditions: HIV-1 Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 167
Healthy volunteers: no

Brief summary:
This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).

Detailed description:

Arms:
arm 1: Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), calcium carbonate and vitamin D3 4000 IU. arm 2: Participants were administered FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla), a placebo for calcium carbonate, and a placebo for vitamin D3.

Interventions: intervention 1: EFV/FTC/TDF intervention 2: Calcium Carbonate intervention 3: Vitamin D3 intervention 4: Placebo for calcium carbonate intervention 5: Placebo for vitamin D3
Intervention descriptions: intervention 1: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach. intervention 2: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks. intervention 3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks. intervention 4: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks intervention 5: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Protocol document: