A Trial of Vitamins and HAART in HIV Disease Progression
A Trial of Vitamins and HAART in HIV Disease Progression
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).
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".
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