A Trial of Vitamins and HAART in HIV Disease Progression

July 14, 2020 updated by: Wafaie Fawzi, Harvard School of Public Health (HSPH)

Trial of Vitamins in HIV Progression and Transmission (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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4012

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania
        • Muhimbili University College of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multiple RDA multivitamins
Multivitamins (including B, C, and E)
Dietary supplement: Multivitamins (including B, C and E)
One daily oral dose of 20 mg B1, 20 mg B2, 25 mg B6, 100 mg niacin, 50 μg B12, 0.8 mg folic acid, 500 mg C, and 30 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).
Active Comparator: Single RDA Multivitamins
Multivitamins (including B, C, and E)
Dietary supplement: Multivitamins B, C and E
One daily oral dose of 1.2 mg vitamin B1, 1.2 mg vitamin B2, 1.3 mg vitamin B6, 15 mg niacin, 2.4 μg vitamin B12, 0.4 mg folic acid, 80 mg vitamin C, and 15 mg vitamin E taken taken from randomization until the end of follow-up (24-28 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of a new or recurrent disease progression event, including all-cause death.
Time Frame: within 24 months after randomization
within 24 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: within 24 months of randomization
within 24 months of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Wafaie W Fawzi, MD,DrPh, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 29, 2006

First Submitted That Met QC Criteria

September 29, 2006

First Posted (Estimate)

October 3, 2006

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD32257-01
  • P12981-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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