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NCT Number: NCT00383669

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).

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Disease Attributes Disease Progression Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Muhimbili University College of Health Sciences

Dar es Salaam, Tanzania

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multivitamins (including B, C and E)

Dietary Supplement

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).

Multivitamins B, C and E

Dietary Supplement

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).

Primary outcomes

  1. Development of a new or recurrent disease progression event, including all-cause death.

    Time frame: within 24 months after randomization

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

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

Registry information

Official study title

Trial of Vitamins in HIV Progression and Transmission (A Trial of Vitamins and HAART in HIV Disease Progression)

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 3, 2006
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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