The Effects of Nutritional Supplementation and Drug Abuse on HIV

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), March 2006

First Received: September 6, 2005 Last Updated: March 7, 2006 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	Florida International University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00149656

Purpose

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.

Condition	Intervention
HIV Infections Substance-Related Disorders	Drug: Multivitamins Drug: Selenium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Resource links provided by NLM:

MedlinePlus related topics: AIDS Dietary Supplements

Drug Information available for: Selenium

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

CD4 cell count (measured at Month 24)

Estimated Enrollment:	869
Study Start Date:	June 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149656

Contacts

Contact: Adriana Campa, BS, MBA, PhD

305-348-2871

campaa@fiu.edu

Locations

Botswana
Princess Marina Hospital	Recruiting
Gaborone, Botswana
Contact: Adriana Campa, BS, MBA, PhD 305-348-2871 campaa@fiu.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Florida International University

Investigators

Principal Investigator:

Marianna K. Baum, PhD

Florida International University

More Information

No publications provided

Study ID Numbers:	NIDA-16551-1, R01-16551-1, DPMC
Study First Received:	September 6, 2005
Last Updated:	March 7, 2006
ClinicalTrials.gov Identifier:	NCT00149656 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Treatment Naive
Treatment Experienced

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 22, 2009