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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Substance-Related Disorders | Dietary Supplement: Multivitamins Dietary Supplement: Selenium Other: Placebo | Not Applicable |
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 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 |
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
|
- HIV Disease Progression [ Time Frame: For at least 6 months ]
- Morbidity [ Time Frame: For at least 6 months ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Botswana | |
Princess Marina Hospital | |
Gaborone, Botswana |
Principal Investigator: | Marianna K. Baum, PhD | Florida International University |
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 |