NCT00149552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jun 2001

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

March 5, 2012

Status Verified

March 1, 2012

First QC Date

September 6, 2005

Last Update Submit

March 1, 2012

Conditions

HIV InfectionsSubstance-Related Disorders

Keywords

Treatment NaiveTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Immune failure

    CD4 cell count \<200 cells/uL

    For at least 6 months

Secondary Outcomes (1)

  • Morbidity

    For at least 6 months

Study Arms (2)

Zinc gluconate

ACTIVE COMPARATOR

Zinc supplementation

Dietary Supplement: zinc

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: zinc

Interventions

zincDIETARY_SUPPLEMENT

supplementation with zinc gluconate

PlaceboZinc gluconate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • Drug User
  • Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml

You may not qualify if:

  • Currently participating in an another clinical trial
  • Blood selenium level less than 85 mcg/L
  • Pregnant or intends to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camillus House

Miami, Florida, 33132, United States

Location

Related Publications (1)

  • 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.

    PMID: 20455705DERIVED

MeSH Terms

Conditions

HIV InfectionsSubstance-Related Disorders

Interventions

Zinc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Marianna K. Baum, PhD

    Florida International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2001

Study Completion

January 1, 2007

Last Updated

March 5, 2012

Record last verified: 2012-03

Locations

US(1)