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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Florida International University |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00149656 |
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 |
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HIV Infections Substance-Related Disorders |
Drug: Multivitamins Drug: Selenium |
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 |
Estimated Enrollment: | 869 |
Study Start Date: | June 2003 |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Adriana Campa, BS, MBA, PhD | 305-348-2871 | campaa@fiu.edu |
Botswana | |
Princess Marina Hospital | Recruiting |
Gaborone, Botswana | |
Contact: Adriana Campa, BS, MBA, PhD 305-348-2871 campaa@fiu.edu |
Principal Investigator: | Marianna K. Baum, PhD | Florida International University |
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 |
Treatment Naive Treatment Experienced |
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 |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |