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

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

March 7, 2006

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

CD4 cell count (measured at Month 24)

Original Primary Outcome Measures ^ICMJE

CD4 cell count

Change History

Complete list of historical versions of study NCT00149656 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Effects of Nutritional Supplementation and Drug Abuse on HIV

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections
Substance-Related Disorders

Intervention ^ICMJE

Drug: Multivitamins
Drug: Selenium

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

869

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Adriana Campa, BS, MBA, PhD

305-348-2871

campaa@fiu.edu

Location Countries ^ICMJE

Botswana

Administrative Information

NCT ID ^ICMJE

NCT00149656

Responsible Party

Study ID Numbers ^ICMJE

NIDA-16551-1, R01-16551-1, DPMC

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Florida International University

Investigators ^ICMJE

Principal Investigator:

Marianna K. Baum, PhD

Florida International University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP