Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

NCT ID: NCT00149552

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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HIV Infections Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Zinc gluconate

Zinc supplementation

Group Type ACTIVE_COMPARATOR

zinc

Intervention Type DIETARY_SUPPLEMENT

supplementation with zinc gluconate

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

zinc

Intervention Type DIETARY_SUPPLEMENT

supplementation with zinc gluconate

Interventions

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zinc

supplementation with zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Florida International University

OTHER

Sponsor Role lead

Responsible Party

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Marianna Baum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marianna K. Baum, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

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Camillus House

Miami, Florida, United States

Site Status

Countries

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United States

References

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Baum MK, Lai S, Sales S, Page JB, Campa A. Randomized, controlled clinical trial of zinc supplementation to prevent immunological failure in HIV-infected adults. Clin Infect Dis. 2010 Jun 15;50(12):1653-60. doi: 10.1086/652864.

Reference Type DERIVED
PMID: 20455705 (View on PubMed)

Other Identifiers

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R01DA014966

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-14966-1

Identifier Type: -

Identifier Source: org_study_id

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