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

September 6, 2005
March 1, 2012
June 2001
Not Provided
Immune failure [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
CD4 cell count <200 cells/uL
CD4 cell count
Complete list of historical versions of study NCT00149552 on ClinicalTrials.gov Archive Site
Morbidity [ Time Frame: For at least 6 months ] [ Designated as safety issue: No ]
AIDS related morbidity
Not Provided
Not Provided
Not Provided
 
Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HIV Infections
  • Substance-Related Disorders
Dietary Supplement: zinc
supplementation with zinc gluconate
  • Active Comparator: Zinc gluconate
    Zinc supplementation
    Intervention: Dietary Supplement: zinc
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: zinc
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
231
January 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149552
NIDA-14966-1, R01DA014966
Yes
Marianna Baum, Florida International University
Florida International University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Marianna K. Baum, PhD Florida International University
Florida International University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP