Zinc Therapy in HIV Infected Individuals Who Abuse Drugs

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Zinc Therapy in Zinc Deficient HIV Positive Drug Users

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Marianna Baum, Florida International University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Morbidity [ Time Frame: For at least 6 months ]
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 (Adult, Senior)
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

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

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Marianna K. Baum, PhD	Florida International University

More Information

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

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.


Responsible Party:	Marianna Baum, Professor, Florida International University
ClinicalTrials.gov Identifier:	NCT00149552 History of Changes
Other Study ID Numbers:	NIDA-14966-1 R01DA014966 ( US NIH Grant/Contract Award Number )
Study First Received:	September 6, 2005
Last Updated:	March 1, 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

ClinicalTrials.gov processed this record on June 26, 2017

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