ClinicalTrials.gov
ClinicalTrials.gov Menu

Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00149552
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : March 5, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marianna Baum, Florida International University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infections Substance-Related Disorders Dietary Supplement: zinc Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Zinc Therapy in Zinc Deficient HIV Positive Drug Users
Study Start Date : June 2001
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Zinc gluconate
Zinc supplementation
 Dietary Supplement: zinc
supplementation with zinc gluconate
Placebo Comparator: Placebo
Placebo
 Dietary Supplement: zinc
supplementation with zinc gluconate


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immune failure [ Time Frame: For at least 6 months ]
    CD4 cell count <200 cells/uL


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: For at least 6 months ]
    AIDS related morbidity


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149552


Locations
United States, Florida
Camillus House
Miami, Florida, United States, 33132
Sponsors and Collaborators
Florida International University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Marianna K. Baum, PhD Florida International University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marianna Baum, Professor, Florida International University
ClinicalTrials.gov Identifier: NCT00149552     History of Changes
Other Study ID Numbers: NIDA-14966-1
R01DA014966 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Marianna Baum, Florida International University:
Treatment Naive
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs