The Effects of Nutritional Supplementation and Drug Abuse on HIV

Not Applicable

Completed

• Conditions: HIV Infections; Substance-Related Disorders
• Interventions: Other: Placebo; Dietary Supplement: Multivitamins; Dietary Supplement: Selenium

• Registration Number: NCT00149656
• Lead Sponsor: Florida International University

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2010-07
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-26
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 878

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Multivitamins	Multivitamins
3	Multivitamins	Multivitamins with Selenium
3	Selenium	Multivitamins with Selenium
4	Selenium	Selenium

Primary Outcome Measures

Name	Time	Method
HIV Disease Progression	For at least 6 months

Secondary Outcome Measures

Name	Time	Method
Morbidity	For at least 6 months

Trial Locations

Locations (1)

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana