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Tuberculosis in a Multiethnic Inner City Population
This study has been completed.
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005379
  Purpose

To determine the incidence of tuberculosis in an inner city population, identify risk factors for TB, describe the natural history in adults and children, evaluate the effect of Mycobacterium tuberculosis (Mtb) co-infection on the progression of human immunodeficiency virus disease, and determine factors that contribute to compliance and non-compliance with prophylaxis and treatment.


Condition
Acquired Immunodeficiency Syndrome
HIV Infections
Lung Diseases
Tuberculosis
Mycobacterium Tuberculosis

MedlinePlus related topics: AIDS Tuberculosis
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1994
Estimated Study Completion Date: July 1999
Detailed Description:

BACKGROUND:

The research provided urgently needed information regarding incidence, risk factors, natural history, molecular epidemiology, treatment, and prevention of tuberculosis in an especially vulnerable multi-ethnic inner-city population with a high HIV seropositivity rate.

The study was part of a collaborative project on minority health, The Epidemiology, Drug Resistance, and Therapy of Tuberculosis in a Multi-Ethnic Inner City Population with a High HIV Seropositivity Rate. The 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The concept for the initiative was developed by the NHLBI staff and approved by the September 1992 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

The study was conducted prospectively and retrospectively in three groups of patients: intravenous drug users and their sexual contacts in an already-recruited cohort; children who received their primary care at Bellevue Hospital Medical Center; and Bellevue Hospital Center inpatients with TB and outpatients who underwent prophylactic treatment. In addition to environmental risk factors (e.g., hopelessness, cohabitation with tuberculosis patients and injected drug use), host factors were investigated, including: HIV infection; immune status among HIV- seropositive persons, as indicated by quantitative p24 antibodies; CD4, CD8, and gammadelta T cell counts; and race, age, and nutritional status. Incidence and risk-factors in the cohort were assessed by interview, blood draw, PPD screening, medical record review, and anergy panel. Natural history and impact on HIV disease in adult and pediatric populations were assessed by interviews, clinical screening and laboratory measures. Drug sensitivity testing and RFLP typing of specimens from the two populations were conducted, respectively, at the Bellevue Mycobacteriology Lab and the Public Health Research Institute. Factors affecting treatment compliance were assessed by self-administered questionnaire.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Study ID Numbers: 4283
Study First Received: May 25, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005379     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Bacterial Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Mycobacterium Infections
Tuberculosis
Retroviridae Infections

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

ClinicalTrials.gov processed this record on May 07, 2009