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Clinical Trials

MainTitle

The Effects of Nutritional Supplementation and Drug Abuse on HIV

This study has been completed
Sponsor
Florida International University

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

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
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana

Further study details as provided by Florida International University:

Primary Outcome Measures

  • HIV Disease Progression [ Time Frame: For at least 6 months ]
Secondary Outcome Measures:
  • Morbidity [ Time Frame: For at least 6 months ]

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

Eligibility

Ages Eligible for Study: 18 Years to 90 Years  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


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  

Keywords provided by Florida International University:

Treatment Naive
Multivitamins
Selenium
Supplementation
HIV Disease Progression

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Selenium

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.