The purpose of this trial is to determine whether supplementation with multivitamins and selenium improves immune function in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression...
Date First Received: September 6, 2005
Last Updated: March 7, 2006
Verified by: National Institute on Drug Abuse (NIDA), March 2006
Clinical Trial Phase: N/A | Start Date: June 2003
Overall Status: Recruiting
Estimated Enrollment: 869
Brief Summary
Official Title: “HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana”
Condition Keyword(s):
Intervention(s):
The purpose of this trial is to determine whether supplementation with multivitamins and selenium improves immune function 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: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
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 supplementation significantly increases CD4 counts in pregnant women, and that selenium supplementation slows the progression of HIV. 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
- Drug: Multivitamins
- Drug: Selenium
Outcome Measures for this Clinical Trial
Primary Measures
- CD4 cell count (measured at Month 24)
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 Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
Marianna K. Baum, PhD Principal Investigator Florida International University
Overall Contact: Adriana Campa, BS, MBA, PhD 305-348-2871 campaa@fiu.edu
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
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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