Trial of Vitamins in HIV Progression and Transmission (A Trial of Vitamins and HAART in HIV Disease Progression)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Harvard School of Public Health (HSPH)
- Enrollment
- 4012
- Locations
- 1
- Primary Endpoint
- Development of a new or recurrent disease progression event, including all-cause death.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is a double-blind randomized clinical trial, conducted to examine the effects of multivitamins (including B, C, and E) on HIV disease progression among HIV-positive Tanzanian adult men and women taking highly active anti-retroviral therapy (HAART).
Detailed Description
Access to Highly Active Anti-Retroviral Therapy (HAART) for the treatment of HIV in developing regions is limited, but gradually becoming standard of care in some countries. Multivitamin supplements have demonstrated immune-enhancing effects among individuals in pre-HAART HIV disease stages. However, the efficacy and safety of micronutrient supplements need to be documented in the context of HAART. This study is a double-blind randomized clinical trial, conducted to examine the effect of multivitamins (including B, C, and E) on HIV disease progression among individuals taking HAART. Participants are HIV-positive Tanzanian men and women aged 18 years and older, who are initiating HAART at the time of randomization. Eligible individuals are randomized to receive daily oral supplements in one of two intervention groups: a) multivitamins at the single Recommended Dietary Allowance (RDA) level; and b) multivitamins at multiples of the RDA at the same doses used in our previous study "A Trial of Vitamins in HIV Progression and Transmission".
Investigators
Wafaie Fawzi
Chair, Department of Global Health and Population
Harvard School of Public Health (HSPH)
Eligibility Criteria
Inclusion Criteria
- •HIV-positive
- •Men or Women
- •18 Years of Age or older
- •Initiating HAART at time of randomization
Exclusion Criteria
- •Pregnant or Lactating Women
- •Individuals at pre-HAART disease stages
- •BMI less than 16
Outcomes
Primary Outcomes
Development of a new or recurrent disease progression event, including all-cause death.
Time Frame: within 24 months after randomization
Secondary Outcomes
- Changes in: (a) CD4 cell count, (b) plasma HIV-1 RNA concentration, (c) weight, and (d) alteration to second-line anti-retroviral treatment; and occurrence of (a) adverse events, specifically peripheral neuropathy(within 24 months of randomization)