HIV Infections Clinical Trial
Official title:
HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana
Verified date | April 2013 |
Source | Florida International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 878 |
Est. completion date | April 2013 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Botswana | Princess Marina Hospital | Gaborone |
Lead Sponsor | Collaborator |
---|---|
Florida International University | National Institute on Drug Abuse (NIDA) |
Botswana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIV Disease Progression | For at least 6 months | No | |
Secondary | Morbidity | For at least 6 months | No |
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