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Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

Primary Purpose

HIV Infections, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
zinc
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Camillus House

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zinc gluconate

Placebo

Arm Description

Zinc supplementation

Placebo

Outcomes

Primary Outcome Measures

Immune failure
CD4 cell count <200 cells/uL

Secondary Outcome Measures

Morbidity
AIDS related morbidity

Full Information

First Posted
September 6, 2005
Last Updated
March 1, 2012
Sponsor
Florida International University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00149552
Brief Title
Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
Official Title
Zinc Therapy in Zinc Deficient HIV Positive Drug Users
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Substance-Related Disorders
Keywords
Treatment Naive, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc gluconate
Arm Type
Active Comparator
Arm Description
Zinc supplementation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
zinc
Intervention Description
supplementation with zinc gluconate
Primary Outcome Measure Information:
Title
Immune failure
Description
CD4 cell count <200 cells/uL
Time Frame
For at least 6 months
Secondary Outcome Measure Information:
Title
Morbidity
Description
AIDS related morbidity
Time Frame
For at least 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianna K. Baum, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Camillus House
City
Miami
State/Province
Florida
ZIP/Postal Code
33132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20455705
Citation
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.
Results Reference
derived

Learn more about this trial

Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

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