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

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

Purpose

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.

Condition	Intervention
HIV Infections Substance-Related Disorders	Dietary Supplement: Multivitamins Dietary Supplement: Selenium Other: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Dietary Supplements Drug Abuse HIV/AIDS

Drug Information available for: Selenomethionine Selenium

U.S. FDA Resources

Further study details as provided by Florida International University:

Primary Outcome Measures:

HIV Disease Progression [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]

Enrollment:	878
Study Start Date:	June 2003
Estimated Study Completion Date:	December 2013
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	Other: Placebo placebo pill
Experimental: 2 Multivitamins	Dietary Supplement: Multivitamins dietary supplement of multivitamins
Experimental: 3 Multivitamins with Selenium	Dietary Supplement: Multivitamins dietary supplement of multivitamins Dietary Supplement: Selenium dietary supplement of selenium only
Experimental: 4 Selenium	Dietary Supplement: Selenium dietary supplement of selenium only

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 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.

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

Locations

Botswana
Princess Marina Hospital
Gaborone, Botswana

Sponsors and Collaborators

Florida International University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Marianna K. Baum, PhD

Florida International University

More Information

No publications provided

Responsible Party:	Florida International University
ClinicalTrials.gov Identifier:	NCT00149656 History of Changes
Other Study ID Numbers:	NIDA-16551-1, R01DA016551, R01-16551-1, DPMC
Study First Received:	September 6, 2005
Last Updated:	October 22, 2011
Health Authority:	United States: Federal Government

Keywords provided by Florida International University:

Treatment Naive
Multivitamins
Selenium
Supplementation
HIV Disease Progression

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Slow Virus Diseases
Mental Disorders
Selenium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012