The Effects of Nutritional Supplementation and Drug Abuse on HIV

HIV Infections Clinical Trial

Official title:

HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149656
• Other study ID #: NIDA-16551-1
• Secondary ID: R01DA016551R01-1
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: April 26, 2013
• Start date: June 2003
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 878
• Est. completion date: April 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Substance-Related Disorders

Intervention

Dietary Supplement:
• Multivitamins
dietary supplement of multivitamins
• Selenium
dietary supplement of selenium only

Other:
• Placebo
placebo pill

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital	Gaborone

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Disease Progression		For at least 6 months	No
Secondary	Morbidity		For at least 6 months	No