The Effects of Nutritional Supplementation and Drug Abuse on HIV

Florida International University (FIU)

Status: Completed

Conditions: Substance-Related Disorders; HIV Infections

Treatments: Dietary Supplement: Selenium; Dietary Supplement: Multivitamins; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00149656

NIDA-16551-1

R01-16551-1

R01DA016551 (U.S. NIH Grant/Contract)

DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 878 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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878 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Other: Placebo

2

Experimental group

Description:

Multivitamins

Treatment:

Dietary Supplement: Multivitamins

3

Experimental group

Description:

Multivitamins with Selenium

Treatment:

Dietary Supplement: Multivitamins

Dietary Supplement: Selenium

4

Experimental group

Description:

Selenium

Treatment:

Dietary Supplement: Selenium