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NCT00149552 Clinical Trial

Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

HIV Infections Clinical Trial

Official title:
Zinc Therapy in Zinc Deficient HIV Positive Drug Users

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00149552
Other study ID # NIDA-14966-1
Secondary ID R01DA014966
Status Completed
Phase N/A
First received September 6, 2005
Last updated March 1, 2012
Start date June 2001
Est. completion date January 2007

Study information
Verified date March 2012
Source Florida International University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 231
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• zinc
supplementation with zinc gluconate

Locations
Country Name City State
United States Camillus House Miami Florida

Sponsors (2)
Lead Sponsor Collaborator
Florida International University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune failure CD4 cell count <200 cells/uL For at least 6 months No
Secondary Morbidity AIDS related morbidity For at least 6 months No
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