Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
- Conditions
- HIV InfectionsSubstance-Related Disorders
- Interventions
- Dietary Supplement: zinc
- Registration Number
- NCT00149552
- Lead Sponsor
- Florida International University
- Brief Summary
Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.
- Detailed Description
Low levels of zinc are associated with an increased risk of HIV-related death and opportunistic infections in HIV infected individuals. Drug users are especially susceptible to zinc deficiency. The purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in HIV infected individuals who abuse drugs.
This trial will last 30 months. Participants will be randomly assigned to receive either zinc supplements or placebo. Male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. Clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- HIV infected
- Drug User
- Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml
- Currently participating in an another clinical trial
- Blood selenium level less than 85 mcg/L
- Pregnant or intends to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zinc gluconate zinc Zinc supplementation Placebo zinc Placebo
- Primary Outcome Measures
Name Time Method Immune failure For at least 6 months CD4 cell count \<200 cells/uL
- Secondary Outcome Measures
Name Time Method Morbidity For at least 6 months AIDS related morbidity
Trial Locations
- Locations (1)
Camillus House
🇺🇸Miami, Florida, United States