The Effects of Nutritional Supplementation and Drug Abuse on HIV
This study has been completed.
Sponsor:
Florida International University
Collaborator:
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
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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 Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana |
Resource links provided by NLM:
Further study details as provided by Florida International University:
Primary Outcome Measures:
- HIV Disease Progression [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Morbidity [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149656
Locations
| Botswana | |
| Princess Marina Hospital | |
| Gaborone, Botswana | |
Sponsors and Collaborators
Florida International University
Investigators
| Principal Investigator: | Marianna K. Baum, PhD | Florida International University |
More Information
No publications provided
| 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 |
| Health Authority: | United States: Federal Government |
Keywords provided by Florida International University:
|
Treatment Naive Multivitamins Selenium Supplementation HIV Disease Progression |
Additional relevant MeSH terms:
|
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Selenium Antioxidants Growth Substances |
Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Trace Elements |
ClinicalTrials.gov processed this record on February 27, 2015