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A Trial of Vitamins and HAART in HIV Disease Progression

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ClinicalTrials.gov Identifier: NCT00383669
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : July 16, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Dietary Supplement: Multivitamins (including B, C and E) Dietary Supplement: Multivitamins B, C and E Phase 3

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4012 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : November 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).




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

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383669


Locations
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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
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Principal Investigator: Wafaie W Fawzi, MD,DrPH Harvard School of Public Health
  Study Documents (Full-Text)

Documents provided by Wafaie Fawzi, Harvard School of Public Health:
Informed Consent Form  [PDF] July 19, 2006

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wafaie Fawzi, Chair, Department of Global Health and Population, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00383669    
Other Study ID Numbers: HD32257-01
P12981-101
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Keywords provided by Wafaie Fawzi, Harvard School of Public Health:
HIV
AIDS
Disease Progression
Multivitamins
Anti-Retroviral Therapy
HAART
Tanzania
Africa
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes