The Effects of Nutritional Supplementation and Drug Abuse on HIV

Florida International University (FIU) logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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