HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Florida International University
- Enrollment
- 878
- Locations
- 1
- Primary Endpoint
- HIV Disease Progression
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.
Detailed Description
Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana. This trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV infected
- •CD4 count greater than 350 cells/mm3
- •Identified from the Infectious Disease Care Clinic
- •Body mass index greater than 18 for women and greater than 18.5 for men
Exclusion Criteria
- •Current AIDS-defining condition
- •Currently participating in another clinical trial
- •Pregnant or intends to become pregnant during the study
Outcomes
Primary Outcomes
HIV Disease Progression
Time Frame: For at least 6 months
Secondary Outcomes
- Morbidity(For at least 6 months)