High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Calcium Calcium Carbonate Calcium, Dietary Cholecalciferol Efavirenz Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Ergocalciferols Tenofovir Vitamin D Vitamins