The Effects of Nutritional Supplementation and Drug Abuse on HIV

Study Overview
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Brief Summary
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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
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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.

Official Title
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HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Conditions
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HIV Infections, Substance-Related Disorders

Intervention / Treatment
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* Dietary Supplement: Multivitamins
* Dietary Supplement: Selenium
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Other: Placebo<br>* placebo pill<br>|
| Experimental: 2<br>Multivitamins | Dietary Supplement: Multivitamins<br>* dietary supplement of multivitamins<br>|
| Experimental: 3<br>Multivitamins with Selenium | Dietary Supplement: Multivitamins<br>* dietary supplement of multivitamins<br>Dietary Supplement: Selenium<br>* dietary supplement of selenium only<br>|
| Experimental: 4<br>Selenium | Dietary Supplement: Selenium<br>* dietary supplement of selenium only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Disease Progression |  | For at least 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | For at least 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Naive, Multivitamins, Selenium, Supplementation, HIV Disease Progression