A Registry of Tuberculosis Cases in the CPCRA - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000785

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

MedlinePlus related topics: AIDS Tuberculosis

Drug Information available for: Casein

U.S. FDA Resources

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

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Enrollment:	1509
Study Start Date:	August 1992
Primary Completion Date:	November 1998 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000785

Locations

United States, Colorado
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
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
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
United States, New Jersey
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10456
Clinical Directors Network of Region II
New York, New York, United States, 10011
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 972109951
United States, Virginia
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Fred Gordin

More Information

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.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	CPCRA 017
Study First Received:	November 2, 1999
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00000785
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

Study placed in the following topic categories:

Bacterial Infections
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Caseins

Gram-Positive Bacterial Infections
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Tuberculosis
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases

Lentivirus Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009