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CompletedNCT00000785Updated Oct 1, 2013

A Registry of Tuberculosis Cases in the CPCRA

An observational study in HIV Infections and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 13 sites in United States. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2013-10-01.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Time perspective
Cross-sectional
Enrollment
1,509
Ages
1 Day and older
Sex
All
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Study summary

PRIMARY: To estimate the proportion of tuberculosis patients in the CPCRA who have drug-resistant tuberculosis (TB) and to describe the patterns of drug resistance.

SECONDARY: To compare drug resistance data on the Mycobacterium tuberculosis isolates of HIV-infected patients to those of HIV-uninfected patients who are being followed in the CPCRA. To assess the relationship of resistance data with geographic, demographic, and HIV and TB risk factor information.

Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will develop, or who have experienced, confirmed TB is unknown. It is critical to determine the depth and breadth of the current problem of drug-resistant TB.

Read the detailed description

Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic. The total number of CPCRA patients who will develop, or who have experienced, confirmed TB is unknown. It is critical to determine the depth and breadth of the current problem of drug-resistant TB.

For both retrospective and prospective components of the study, demographic, geographic, HIV and TB risk factor information will be collected on CPCRA patients with confirmed pulmonary or extrapulmonary TB. Mycobacterial culture results will be recorded. Retrospective data will be collected on CPCRA patients with confirmed tuberculosis who have been diagnosed since January 1992 until the time of site registration. Prospective data will be collected on CPCRA patients with confirmed tuberculosis diagnosed during the period of 1 to 2 years following site registration.

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Conditions studied

  • HIV Infections
  • Tuberculosis

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Keywords

  • Tuberculosis
  • Mycobacterium tuberculosis
  • AIDS-Related Opportunistic Infections
  • Acquired Immunodeficiency Syndrome
  • Drug Resistance, Microbial
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 1,509 is above the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All eligible CPCRA subjects

Eligibility criteria

Patients must meet the following criteria:

  • CPCRA patients with confirmed pulmonary or extrapulmonary TB. Confirmed clinical TB requires a positive culture for Mycobacterium tuberculosis.

NOTE:

  • There is no requirement that patients have HIV infection.
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Study design

Time perspective
Cross-sectional
Enrollment
1,509 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • A

    All eligible CPCRA subjects

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Study locations

13 sites
  • Denver CPCRA / Denver Public Hlth
    Denver, Colorado 80204, United States
  • Veterans Administration Med Ctr / Regional AIDS Program
    Washington, District of Columbia 20422, United States
  • AIDS Research Alliance - Chicago
    Chicago, Illinois 60657, United States
  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
    New Orleans, Louisiana 70112, United States
  • Comprehensive AIDS Alliance of Detroit
    Detroit, Michigan 48201, United States
  • Henry Ford Hosp
    Detroit, Michigan 48202, United States
  • North Jersey Community Research Initiative
    Newark, New Jersey 07103, United States
  • Bronx Lebanon Hosp Ctr
    Bronx, New York 10456, United States
  • Addiction Research and Treatment Corp
    Brooklyn, New York 11201, United States
  • Clinical Directors Network of Region II
    New York, New York 10011, United States
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
    New York, New York 10037, United States
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    Portland, Oregon 97210, United States
  • Richmond AIDS Consortium
    Richmond, Virginia 23298, United States
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References and documents

Publications

  • Gordin FM, Nelson ET, Matts JP, Cohn DL, Ernst J, Benator D, Besch CL, Crane LR, Sampson JH, Bragg PS, El-Sadr W. The impact of human immunodeficiency virus infection on drug-resistant tuberculosis. Am J Respir Crit Care Med. 1996 Nov;154(5):1478-83. doi: 10.1164/ajrccm.154.5.8912768. PubMed 8912768 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000785
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Aug 31, 2001
Start date
Aug 1992
Primary completion
Jun 1994
Completion
Jun 1994
Last update
Oct 1, 2013

Study contacts

Fred Gordin
study chair
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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