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The Effects of Nutritional Supplementation and Drug Abuse on HIV

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ClinicalTrials.gov Identifier: NCT00149656
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : April 29, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Florida International University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Substance-Related Disorders Dietary Supplement: Multivitamins Dietary Supplement: Selenium Other: Placebo Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 878 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana
Study Start Date : June 2003
Actual Primary Completion Date : July 2010
Actual Study Completion Date : April 2013

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. HIV Disease Progression [ Time Frame: For at least 6 months ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: For at least 6 months ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT00149656     History of Changes
Other Study ID Numbers: NIDA-16551-1
R01DA016551 ( U.S. NIH Grant/Contract )
R01-16551-1
DPMC
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Florida International University:
Treatment Naive
Multivitamins
Selenium
Supplementation
HIV Disease Progression

Additional relevant MeSH terms:
HIV Infections
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
 Chemically-Induced Disorders
Mental Disorders
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances