The Effects of Nutritional Supplementation and Drug Abuse on HIV

HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149656

Enrollment

878

Registered

2005-09-08

Start date

2003-06-30

Completion date

2013-04-30

Last updated

2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Substance-Related Disorders

Keywords

Treatment Naive, Multivitamins, Selenium, Supplementation, HIV Disease Progression

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.

Interventions

DIETARY_SUPPLEMENTMultivitamins

dietary supplement of multivitamins

DIETARY_SUPPLEMENTSelenium

dietary supplement of selenium only

OTHERPlacebo

placebo pill

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HIV Disease Progression	For at least 6 months

Secondary

Measure	Time frame
Morbidity	For at least 6 months

Countries

Botswana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026