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The Effects of Nutritional Supplementation and Drug Abuse on HIV

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Florida International University
ClinicalTrials.gov Identifier:
NCT00149656
First received: September 6, 2005
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  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:

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
Study Completion Date: April 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: April 26, 2013
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 May 23, 2013