NCT00000785

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1992

Geographic Reach
1 country

13 active sites

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

August 1, 1992

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1994

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

November 2, 1999

Last Update Submit

September 28, 2013

Conditions

Keywords

TuberculosisMycobacterium tuberculosisAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency SyndromeDrug Resistance, Microbial

Study Arms (1)

A

All eligible CPCRA subjects

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible CPCRA subjects

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.

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

Sponsors & Collaborators

Study Sites (13)

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 80204, United States

Location

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, 20422, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 07103, United States

Location

Addiction Research and Treatment Corp

Brooklyn, New York, 11201, United States

Location

Clinical Directors Network of Region II

New York, New York, 10011, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10456, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 97210, United States

Location

Richmond AIDS Consortium

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • 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.

    PMID: 8912768BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

HIV InfectionsTuberculosisAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fred Gordin

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

August 1, 1992

Primary Completion

June 1, 1994

Study Completion

June 1, 1994

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations