Completed

A Registry of Tuberculosis Cases in the CPCRA

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
DNA Samples
Who is being recruted

HIV Infections

+ Tuberculosis

See all eligibility criteria

How is the trial designed

Other

Observational
Study Start: August 1992

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 1, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1992Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Registry of Tuberculosis Cases in the CPCRA 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 1, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1509 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

What happens to patients' samples
Samples from participants are kept, and they can be used to extract DNA in the future. These might include things like blood or frozen tissue. This allows researchers to study genetics and how DNA may relate to the disease.

Other Options for Sample Use
Samples Without DNA: Samples are kept but not usable for DNA analysis.
None Retained: No samples are kept after the study.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers collect data at a single point in time, offering a snapshot of health, exposures, or conditions in a specific population. These studies are useful for understanding current patterns and prevalence.Other Ways to Collect Data
Prospective: These studies collect new data moving forward over time.
Retrospective: These studies use existing medical records or past data.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Tuberculosis
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
All eligible CPCRA subjects

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 13 locations
Suspended
Denver CPCRA / Denver Public HlthDenver, United StatesSee the location
Suspended
Veterans Administration Med Ctr / Regional AIDS ProgramWashington, United States
Suspended
AIDS Research Alliance - ChicagoChicago, United States
Suspended
Louisiana Comm AIDS Rsch Prog / Tulane Univ MedNew Orleans, United States
Completed13 Study Centers