Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Marianna Baum, Florida International University
ClinicalTrials.gov Identifier:
NCT00149552
First received: September 6, 2005
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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 Intervention
HIV Infections
Substance-Related Disorders
Dietary Supplement: zinc

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Zinc Therapy in Zinc Deficient HIV Positive Drug Users

Resource links provided by NLM:


Further study details as provided by Florida International University:

Primary Outcome Measures:
  • Immune failure [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
    CD4 cell count <200 cells/uL


Secondary Outcome Measures:
  • Morbidity [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
    AIDS related morbidity


Enrollment: 231
Study Start Date: June 2001
Study Completion Date: January 2007
Arms Assigned Interventions
Active Comparator: Zinc gluconate
Zinc supplementation
Dietary Supplement: zinc
supplementation with zinc gluconate
Placebo Comparator: Placebo
Placebo
Dietary Supplement: zinc
supplementation with zinc gluconate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149552

Locations
United States, Florida
Camillus House
Miami, Florida, United States, 33132
Sponsors and Collaborators
Florida International University
Investigators
Principal Investigator: Marianna K. Baum, PhD Florida International University
  More Information

No publications provided by Florida International University

Additional 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
Study First Received: September 6, 2005
Last Updated: March 1, 2012
Health Authority: United States: Federal Government

Keywords provided by Florida International University:
Treatment Naive
Treatment Experienced

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

ClinicalTrials.gov processed this record on October 29, 2014