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A Registry of Tuberculosis Cases in the CPCRA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000785
First received: November 2, 1999
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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.


Condition
HIV Infections
Tuberculosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: A Registry of Tuberculosis Cases in the CPCRA

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Any sample that can be used to test for M.tuberculosis


Enrollment: 1509
Study Start Date: August 1992
Study Completion Date: June 1994
Primary Completion Date: June 1994 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
All eligible CPCRA subjects

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All eligible CPCRA subjects

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.
  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: NCT00000785

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

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000785     History of Changes
Other Study ID Numbers: CPCRA 017, 11568
Study First Received: November 2, 1999
Last Updated: September 28, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Tuberculosis
Mycobacterium tuberculosis
AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
Drug Resistance, Microbial

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014