A Trial of Vitamins and HAART in HIV Disease Progression

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Dietary Supplement: Multivitamins B, C and E; Dietary Supplement: Multivitamins (including B, C and E)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00383669

HD32257-01

P12981-101

Details and patient eligibility

About

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).

Full 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".

Enrollment: 4,012 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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4,012 participants in 2 patient groups

Multiple RDA multivitamins

Active Comparator group

Description:

Multivitamins (including B, C, and E)

Treatment:

Dietary Supplement: Multivitamins (including B, C and E)

Single RDA Multivitamins

Active Comparator group

Description:

Multivitamins (including B, C, and E)

Treatment:

Dietary Supplement: Multivitamins B, C and E