Status:
COMPLETED
Multi-vitamins, HAART and HIV/AIDS in Uganda
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Makerere University
Infectious Disease Institute, Kampala, Uganda
Conditions:
HIV/AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progres...
Detailed Description
Antiretroviral therapy, gradually becoming the standard of care in developing countries, confers enormous benefits and yet substantial morbidity remains in human immunodeficiency virus (HIV) positive ...
Eligibility Criteria
Inclusion
- men or women aged \>=18 years old
- HIV-positive
- initiating anti-retroviral therapy at the time of randomization or have been on highly active anti-retroviral therapy (HAART) for no more than 6 months
- have no intention of migrating, or re-locating \>= 20 km outside of the Infectious Disease Institute (IDI), or Kiswa Health Center within the next 18 months after enrollment
- agree to allow home visit(s) and subsequent follow-up contacts as part of the study
- provide written informed consent
Exclusion
- pregnant Women
- individuals from whom we are unable to obtain written informed consent will be excluded from the study. For example, patients that are extremely ill and unable to consent will be excluded.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01228578
Start Date
April 1 2010
End Date
November 1 2013
Last Update
May 22 2014
Active Locations (1)
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1
Makerere University School of Public Health / Infectious Disease Institute
Kampala, Uganda