HIV Infections, Substance-Related Disorders
Conditions
Keywords
Treatment Naive, Treatment Experienced
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.
Interventions
DIETARY_SUPPLEMENTzinc
supplementation with zinc gluconate
Sponsors
National Institute on Drug Abuse (NIDA)
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV infected * Drug User * Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml
Exclusion criteria
* Currently participating in an another clinical trial * Blood selenium level less than 85 mcg/L * Pregnant or intends to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune failure | For at least 6 months | CD4 cell count \<200 cells/uL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | For at least 6 months | AIDS related morbidity |
Countries
United States
Outcome results
None listed