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Sponsors and Collaborators: |
Harvard School of Public Health Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Harvard School of Public Health |
ClinicalTrials.gov Identifier: | NCT00383669 |
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 |
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HIV Infections |
Drug: Multivitamins (including B, C and E) Drug: Multivitamins including B,C and E Drug: Multivitamins B, C and E |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Trial of Vitamins in HIV Progression and Transmission (A Trial of Vitamins and HAART in HIV Disease Progression) |
Estimated Enrollment: | 4000 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Multiple RDA multivitamins
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Drug: Multivitamins (including B, C and E)
Multiple RDA Multivitamins (including B, C and E)
Drug: Multivitamins including B,C and E
Multiple RDA multivitamins
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2: Placebo Comparator
Single RDA Multivitamins
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Drug: Multivitamins B, C and E
Single RDA multivitamins
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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".
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wafaie W Fawzi, MD, DrPH | 617-432-2086 | mina@hsph.harvard.edu |
Tanzania | |
Muhimbili University College of Health Sciences | Recruiting |
Dar es Salaam, Tanzania | |
Contact: Ferdinand Mugusi, MD, MMed fmugusi@muchs-harvard.org |
Principal Investigator: | Wafaie W Fawzi, MD,DrPH | Harvard School of Public Health |
Responsible Party: | Harvard School of Public Health ( Wafaie Fawzi ) |
Study ID Numbers: | HD32257-01, P12981-101 |
Study First Received: | September 29, 2006 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00383669 History of Changes |
Health Authority: | United States: Institutional Review Board; Tanzania: Institutional Review Board |
HIV AIDS Disease Progression Multivitamins |
Anti-Retroviral Therapy HAART Tanzania Africa |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Vitamins Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Disease Progression Trace Elements Micronutrients Retroviridae Infections Immunologic Deficiency Syndromes |
Disease Attributes RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Growth Substances Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Disease Progression Infection |
Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pathologic Processes HIV Infections Vitamins Sexually Transmitted Diseases Lentivirus Infections Micronutrients Retroviridae Infections |