Phase
Condition
Lung Disease
Hiv
Treatment
RPT + INH once weekly for 3 months given by DOT
Isoniazid (INH) daily for 9 months
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
INCLUSION criteria:
Males or nonpregnant, non-nursing females > 2 years old.
Tuberculin (PPD) skin test reactors at high risk for developing TB but withoutevidence of active TB. High-risk reactors are defined as:
Household and other close contacts of persons with culture-confirmed TB who areTST-positive as part of a contact investigation conducted within two years ofthe date of enrollment. Close contact is defined as > 4 hours in a sharedairspace during a one-week period. Among close contacts, a positive TST isdefined as > 5 mm induration after 5 TU of PPD placed intradermally using theMantoux technique.
TST converters--converting from a documented negative to positive TST within atwo-year period. This is defined as persons with a tuberculin skin test of > 10mm within two years of a nonreactive test or persons with an increase of > 10mm within a two-year period.
HIV-seropositive, TST positive (> 5 mm induration) persons.
Persons with > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no priorhistory of TB treatment, > 5 mm induration on TST, and 3 sputum culturesnegative for M. tuberculosis on final report.
HIV-seropositive close contacts of persons with culture-confirmed TB, regardless ofTST status. In addition, HIV-seropositive close contacts of persons withculture-confirmed TB who have a documented history of completing an adequate courseof treatment for active TB or latent TB infection, are also eligible.
Willing to provide signed informed consent, or parental consent and participantassent.
Exclusion
EXCLUSION criteria:
Current confirmed culture-positive or clinical TB
Suspected TB (as defined by the site investigator)
Tuberculosis resistant to isoniazid or rifampin in the source case
A history of treatment for > 14 consecutive days with a rifamycin or > 30consecutive days with INH during the previous 2 years.
A documented history of a completing an adequate course of treatment for active TBor latent TB infection in a person who is HIV-seronegative.
History of sensitivity/intolerance to isoniazid or rifamycins
Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal amongpersons in whom AST is determined
Pregnant or nursing females
Persons currently receiving or planning to receive HIV-1 protease inhibitors ornonnucleoside reverse transcriptase inhibitors in the first 90 days afterenrollment.
Weight < 10.0 kg
Study Design
Study Description
Connect with a study center
Universidade Federal do Rio de Janeiro
Rio de Janeiro, cep: 21941.590
BrazilSite Not Available
University of British Columbia
Vancouver, British Columbia Canada V5Z 4R4
CanadaSite Not Available
University of Manitoba
Winnipeg, Manitoba CANADA R3A 1R8
CanadaSite Not Available
Montreal Chest Institute McGill University
Montreal, Quebec H2X 2P4Pq Canada
CanadaSite Not Available
Agencia de Salut Publica
Barcelona, 08023
SpainSite Not Available
Central Arkansas Veterans Health System
Little Rock, Arkansas 72205
United StatesSite Not Available
LA County/USC Medical Center
Los Angeles, California 90033
United StatesSite Not Available
UCSD Medical Center
San Diego, California 92103
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94110
United StatesSite Not Available
Denver Department of Public Health and Hospitals
Denver, Colorado 80204
United StatesSite Not Available
Washington, D.C. VAMC
Washington, District of Columbia 20422
United StatesSite Not Available
Emory University, Department of Medicine
Atlanta, Georgia 30303
United StatesSite Not Available
Chicago VA Medical Center (Lakeside)
Chicago, Illinois 60611
United StatesSite Not Available
Hines VA Medical Center
Hines, Illinois 60141
United StatesSite Not Available
Johns Hopkins University School of Medicine
Baltimore, Maryland 21287-0003
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
New Jersey Medical School
Newark, New Jersey 07107-3001
United StatesSite Not Available
Columbia University/Presbyterian Medical Center
New York, New York 10032
United StatesSite Not Available
Harlem Hospital Center
New York, New York 10037
United StatesSite Not Available
Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 34222
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
University of North Texas Health Science Center
Fort Worth, Texas 76107-2699
United StatesSite Not Available
Michael Debakey Veterans Affairs Medical Center
Houston, Texas 77009
United StatesSite Not Available
Audi L. Murphy VA Hospital
San Antonio, Texas 78284
United StatesSite Not Available
Seattle King County Health Department
Seattle, Washington 98104
United StatesSite Not Available
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