A Trial of Vitamins and HAART in HIV Disease Progression

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Dietary Supplement: Multivitamins (including B, C and E); Dietary Supplement: Multivitamins B, C and E

• Registration Number: NCT00383669
• Lead Sponsor: Harvard School of Public Health (HSPH)

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".

Study Timeline

• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study First Posted: 2006-10-03
• Study Start: 2006-11
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4012

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Multiple RDA multivitamins	Multivitamins (including B, C and E)	Multivitamins (including B, C, and E)
Single RDA Multivitamins	Multivitamins B, C and E	Multivitamins (including B, C, and E)

Primary Outcome Measures

Name	Time	Method
Development of a new or recurrent disease progression event, including all-cause death.	within 24 months after randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Muhimbili University College of Health Sciences; 🇹🇿 Dar es Salaam, Tanzania