Multi-vitamins, HAART and HIV/AIDS in Uganda

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-11-30

Brief Summary

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The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progression, indicated by increased CD4 count, weight gain, and improved quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e. peripheral neuropathy, anemia, and diarrhea).

The investigators hypothesize that daily multivitamin supplementation will: (1) improve immune reconstitution; (2) improve weight gain, and (3) improve quality of life.

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Detailed Description

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Antiretroviral therapy, gradually becoming the standard of care in developing countries, confers enormous benefits and yet substantial morbidity remains in human immunodeficiency virus (HIV) positive populations. Multivitamin supplements have immune-enhancing effects, and supplements were found to improve immunologic status and reduce morbidity and mortality among HIV-positive Tanzanian women in pre-highly active anti-retroviral therapy (HAART) stages of disease. These supplements are thought to be required to restore adequate nutrient levels in the context of HIV infection.

This study will enroll 400 men and women in the Kampala district of Uganda, who are receiving or have recently initiated HAART. At baseline and monthly thereafter, research physicians and nurses at study clinics will assess each participant's clinical status and undertake study procedures. Each participant will be followed for 18 months, or until his/her death or loss to follow-up. Home visits will be conducted if participants miss their scheduled clinic appointments. We will perform nutritional assessments (anthropometry and dietary intake) at enrollment and several follow-up points, and laboratory measurements (CD4 cell counts and complete blood counts) every six months.

Importantly, all study participants will continue receiving the standard of care according to national guidelines for the entire study period. Multivitamins could be a low-cost, adjunct therapy for helping to alleviate disease burden and elevate quality of life in HIV-infected individuals on HAART. At the same time, their efficacy could help preserve limited drug regimens in developing settings by postponing the need for switches to second line regimens of HAART.

Our proposal represents a collaboration between the Harvard School of Public Health, Infectious Disease Institute and Makerere University School of Public Health in Kampala, Uganda.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multivitamins (B,C,E)

Group Type EXPERIMENTAL

Multivitamin supplements B,C and E

Intervention Type DIETARY_SUPPLEMENT

One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months

Placebo

Group Type PLACEBO_COMPARATOR

Multivitamin supplements B,C and E

Intervention Type DIETARY_SUPPLEMENT

One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months

Interventions

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Multivitamin supplements B,C and E

One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* men or women aged \>=18 years old
* HIV-positive
* initiating anti-retroviral therapy at the time of randomization or have been on highly active anti-retroviral therapy (HAART) for no more than 6 months
* have no intention of migrating, or re-locating \>= 20 km outside of the Infectious Disease Institute (IDI), or Kiswa Health Center within the next 18 months after enrollment
* agree to allow home visit(s) and subsequent follow-up contacts as part of the study
* provide written informed consent

Exclusion Criteria

* pregnant Women
* individuals from whom we are unable to obtain written informed consent will be excluded from the study. For example, patients that are extremely ill and unable to consent will be excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No