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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

September 6, 2005
April 26, 2013
June 2003
July 2010   (final data collection date for primary outcome measure)
HIV Disease Progression [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
CD4 cell count
Complete list of historical versions of study NCT00149656 on ClinicalTrials.gov Archive Site
Morbidity [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
The Effects of Nutritional Supplementation and Drug Abuse on HIV
HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HIV Infections
  • Substance-Related Disorders
  • Dietary Supplement: Multivitamins
    dietary supplement of multivitamins
  • Dietary Supplement: Selenium
    dietary supplement of selenium only
  • Other: Placebo
    placebo pill
  • Placebo Comparator: 1
    Intervention: Other: Placebo
  • Experimental: 2
    Multivitamins
    Intervention: Dietary Supplement: Multivitamins
  • Experimental: 3
    Multivitamins with Selenium
    Interventions:
    • Dietary Supplement: Multivitamins
    • Dietary Supplement: Selenium
  • Experimental: 4
    Selenium
    Intervention: Dietary Supplement: Selenium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
878
April 2013
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT00149656
NIDA-16551-1, R01DA016551, R01-16551-1, DPMC
Yes
Florida International University
Florida International University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Marianna K. Baum, PhD Florida International University
Florida International University
April 2013

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