NCT01403051

High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART

A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	EFV/FTC/TDF	FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.
DRUG	Calcium Carbonate	Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
DRUG	Vitamin D3	One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
DRUG	Placebo for calcium carbonate	A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
DRUG	Placebo for vitamin D3	A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-07-27
• Last updated: 2018-10-12
• Results posted: 2014-03-19

Locations

39 sites across 2 countries: United States, Puerto Rico