The Effects of Nutritional Supplementation and Drug Abuse on HIV
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...
Brief Summary
Official Title: “HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: July 2010
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Dietary Supplement: Multivitamins
- dietary supplement of multivitamins
- Dietary Supplement: Selenium
- dietary supplement of selenium only
- Other: Placebo
- placebo pill
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 1
- Experimental: 2
- Multivitamins
- Experimental: 3
- Multivitamins with Selenium
- Experimental: 4
- Selenium
Outcome Measures for this Clinical Trial
Primary Measures
- HIV Disease Progression
- Time Frame: For at least 6 months
Safety Issue?: No
- Time Frame: For at least 6 months
Secondary Measures
- Morbidity
- Time Frame: For at least 6 months
Safety Issue?: No
- Time Frame: For at least 6 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 90 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Florida International University Other
Overall Clinical Trial Officials and Contacts
Marianna K. Baum, PhD Principal Investigator Florida International University
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00149656
Study ID Number: NIDA-16551-1
ClinicalTrials.gov Identifier: NCT00149656
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00149656
