Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

March 1, 2012 updated by: Marianna Baum, Florida International University

Zinc Therapy in Zinc Deficient HIV Positive Drug Users

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33132
        • Camillus House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: zinc
supplementation with zinc gluconate
Active Comparator: Zinc gluconate
Zinc supplementation
Dietary supplement: zinc
supplementation with zinc gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune failure
Time Frame: For at least 6 months
CD4 cell count <200 cells/uL
For at least 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: For at least 6 months
AIDS related morbidity
For at least 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida International University

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-14966-1
  • R01DA014966 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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