NCT00005379

Brief Summary

To determine the incidence of tuberculosis in an inner city population, identify risk factors for TB, describe the natural history in adults and children, evaluate the effect of Mycobacterium tuberculosis (Mtb) co-infection on the progression of human immunodeficiency virus disease, and determine factors that contribute to compliance and non-compliance with prophylaxis and treatment.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1994

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1994

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1999

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

4.9 years

First QC Date

May 25, 2000

Last Update Submit

December 28, 2015

Conditions

Study Arms (3)

IV drug users and their sexual contacts

This group will be made up of an already-recruited cohort

Children who receive primary care at Bellevue Hospital

Bellevue Hospital inpatients/outpatients

Inpatients being treated for TB and outpatients receiving prophylactic treatment

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be made up of three cohorts: (1) intravenous drug users and their sexual contacts in an already-recruited cohort; (2) children who receive their primary care at Bellevue Hospital Medical Center; and (3) Bellevue Hospital Center inpatients with TB and outpatients undergoing prophylactic treatment

No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Wolfe H, Marmor M, Maslansky R, Nichols S, Simberkoff M, Des Jarlais D, Moss A. Tuberculosis knowledge among New York City injection drug users. Am J Public Health. 1995 Jul;85(7):985-8. doi: 10.2105/ajph.85.7.985.

    PMID: 7604926BACKGROUND
  • Davidow AL, Marmor M, Alcabes P. Geographic diversity in tuberculosis trends and directly observed therapy, New York City, 1991 to 1994. Am J Respir Crit Care Med. 1997 Nov;156(5):1495-500. doi: 10.1164/ajrccm.156.5.96-12078.

    PMID: 9372666BACKGROUND
  • Davidow AL, Alcabes P, Marmor M. The contribution of recently acquired Mycobacterium tuberculosis infection to the New York City tuberculosis epidemic, 1989-1993. Epidemiology. 2000 Jul;11(4):394-401. doi: 10.1097/00001648-200007000-00006.

    PMID: 10874545BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV InfectionsLung DiseasesTuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRespiratory Tract DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Michael Marmor

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

August 1, 1994

Primary Completion

July 1, 1999

Study Completion

July 1, 1999

Last Updated

December 29, 2015

Record last verified: 2015-12