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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
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
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

MedlinePlus related topics: AIDS Dietary Supplements
Drug Information available for: Selenium
U.S. FDA Resources
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

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
Florida International University
Investigators
Principal Investigator: Marianna K. Baum, PhD Florida International University
  More Information

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  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Virus Diseases
Selenium
Sexually Transmitted Diseases, Viral
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009