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A Trial of Vitamins and HAART in HIV Disease Progression

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00383669
First received: September 29, 2006
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
HIV Infections
 Dietary Supplement: Multivitamins (including B, C and E)
Dietary Supplement: Multivitamins B, C and E
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Vitamins in HIV Progression and Transmission (A Trial of Vitamins and HAART in HIV Disease Progression)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Development of a new or recurrent disease progression event, including all-cause death. [ Time Frame: within 24 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4012
Study Start Date: November 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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".

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383669

Locations
Tanzania
Muhimbili University College of Health Sciences
Dar es Salaam, Tanzania
Sponsors and Collaborators
Harvard School of Public Health
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
  More Information

No publications provided by Harvard School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00383669     History of Changes
Other Study ID Numbers: HD32257-01, P12981-101
Study First Received: September 29, 2006
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Harvard School of Public Health:
HIV
AIDS
Disease Progression
Multivitamins
 Anti-Retroviral Therapy
HAART
Tanzania
Africa

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Progression
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013