The Effects of Nutritional Supplementation and Drug Abuse on HIV - Tabular View

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The Effects of Nutritional Supplementation and Drug Abuse on HIV

This study is currently recruiting participants.

Study NCT00149656. Last updated on March 7, 2006. Information provided by National Institute on Drug Abuse (NIDA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

The Effects of Nutritional Supplementation and Drug Abuse on HIV

Official Title ^†

HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Brief Summary

The purpose of this trial is to determine whether supplementation with multivitamins and selenium improves immune function 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 supplementation significantly increases CD4 counts in pregnant women, and that selenium supplementation slows the progression of HIV. 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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary Outcome Measure ^†

CD4 cell count (measured at Month 24)

Secondary Outcome Measure ^†

Condition ^†

HIV Infections
Substance-Related Disorders

Intervention ^†

Drug: Multivitamins
Drug: Selenium

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

869

Start Date ^†

June 2003

Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Adriana Campa, BS, MBA, PhD

305-348-2871

campaa@fiu.edu

Location Countries ^†

Botswana

Administrative Information Fields

NCT ID ^†

NCT00149656

Organization ID

NIDA-16551-1

Secondary IDs ^††

R01-16551-1, DPMC

Study Sponsor ^†

National Institute on Drug Abuse (NIDA)

Collaborators ^††

Florida International University

Investigators ^†

Principal Investigator:

Marianna K. Baum, PhD

Florida International University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

March 2006

First Received Date ^†

September 6, 2005

Last Updated Date

March 7, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.