A Trial of Vitamins and HAART in HIV Disease Progression

This study has been completed.
Sponsor:
Collaborator:
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

September 29, 2006
September 2, 2011
November 2006
October 2009   (final data collection date for primary outcome measure)
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 ]
Development of a new or recurrent disease progression event, including all-cause death.
Complete list of historical versions of study NCT00383669 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
A Trial of Vitamins and HAART in HIV Disease Progression
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).

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".

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • 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).
  • 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).
  • Active Comparator: Multiple RDA multivitamins
    Multivitamins (including B, C, and E)
    Intervention: Dietary Supplement: Multivitamins (including B, C and E)
  • Active Comparator: Single RDA Multivitamins
    Multivitamins (including B, C, and E)
    Intervention: Dietary Supplement: Multivitamins B, C and E

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4012
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00383669
HD32257-01, P12981-101
Yes
Harvard School of Public Health
Harvard School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Wafaie W Fawzi, MD,DrPH Harvard School of Public Health
Harvard School of Public Health
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP