Phase
Condition
Lung Disease
Hiv
Treatment
Rifapentine daily for 6 weeks
Rifampin and Isoniazid daily for 12 weeks
Rifampin daily for 16 weeks
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or non-pregnant, non-breastfeeding females > 12 years old. Women ofchild-bearing potential who are not surgically sterilized must agree to practice anadequate method of contraception (barrier method or non-hormonal intrauterinedevice) or abstain from heterosexual intercourse during study drug treatment.
Persons with LTBI who do not have evidence of TB disease and are at increased riskof progression to TB. M. tuberculosis infection may be demonstrated by either apositive tuberculin skin test (TST) or a positive interferon gamma release assay (IGRA; e.g., QuantiFERON or T.SPOT.TB). Persons with LTBI at increased risk ofprogression to TB are those with one of the following:
Household and other close contacts (> 4 hours of exposure in a one week period)within 2 years prior to enrollment, of persons with culture-confirmed TB Apositive nucleic acid amplification test (NAAT)/GeneXpert in the source casemay be used for enrollment prior to culture confirmation
Recent M. tuberculosis infection, defined as converting from a documentednegative to positive TST or IGRA within 2 years prior to enrollment. Personswithout known close contact to someone with active pulmonary TB who have aconversion by IGRA may require additional evaluation to rule out a falseconversion.
HIV co-infection (with CD4+ T-lymphocyte count > 100 cells/mm3).
≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior historyof treatment for TB or LTBI.
Recent (within 3 years prior to enrollment) immigration to the United States orother country with low to moderate TB incidence, with abnormal chest X-ray, andno evidence of active TB.
Recent (within 2 years prior to enrollment) immigration to the United States orother country with low to moderate TB incidence, from a country with anestimated incidence rate of TB > 150 per 100,000
An increased risk of TB due to medical conditions such as end-stage renaldisease, or due to use of immunosuppressive medications such as chronicsteroids or TNF-alpha inhibitors.
- Willing to provide signed informed consent, or parental permission and participantassent.
Exclusion
Exclusion Criteria:
Current confirmed culture-positive or clinical TB.
Suspected current TB. Includes cases in which active TB cannot be eliminated as apossibility (by the site investigator)
TB resistant to any rifamycin in the source case
A history of treatment for > 7 consecutive days with a rifamycin or > 30 consecutivedays with INH within 2 years prior to enrollment.
A documented history of completing an adequate course of treatment for TB disease orLTBI in a person who is HIV-seronegative.
History of allergy or intolerance to rifamycins.
Serum alanine aminotransferase (ALT; SGPT) or serum aspartate aminotransferase (AST;SGOT) > 5x upper limit of normal among persons in whom baseline ALT or AST isdetermined+.
HIV-seropositive and on antiretroviral therapy that cannot be given with rifampin orrifapentine due to drug-drug interactions.
Receiving concomitant medications that are known to be contraindicated with anystudy drug.
Females who are currently pregnant, breastfeeding, or intend to become pregnantwithin 120 days of enrollment.
Weight < 25 kg.
Study Design
Connect with a study center
Liverpool Hospital
Sydney,
AustraliaActive - Recruiting
Paramatta Chest
Sydney,
AustraliaActive - Recruiting
Royal Prince Alfred Hospital
Sydney,
AustraliaActive - Recruiting
Calgary TB Clinic
Calgary, Alberta T1Y 6H6
CanadaActive - Recruiting
Edmonton TB Clinic
Edmonton, Alberta
CanadaActive - Recruiting
British Columbia Centre for Disease Control
Vancouver, British Columbia
CanadaActive - Recruiting
Toronto Western Hospital
Toronto, Ontario M5P 1N5
CanadaActive - Recruiting
McGill University Health Centre
Montréal, Quebec H3A 0G4
CanadaActive - Recruiting
Desmond Tutu TB Center
Stellenbosch,
South AfricaSite Not Available
California Department of Public Health
San Francisco, California 94102
United StatesSite Not Available
Denver Health and Hospital Authority
Denver, Colorado 80204
United StatesActive - Recruiting
George Washington University
Washington, District of Columbia 20001
United StatesActive - Recruiting
Washington DC VA Medical Center
Washington, District of Columbia 20001
United StatesActive - Recruiting
New York Harbor Healthcare System
Manhattan, New York 10001
United StatesActive - Recruiting
Columbia University
New York, New York 10027
United StatesSite Not Available
New York City Bureau of TB Control
New York, New York 11201
United StatesActive - Recruiting
Vanderbilt University
Nashville, Tennessee 37235
United StatesSite Not Available
Austin TB Clinic
Austin, Texas 78702
United StatesSite Not Available
University of North Texas Health Science Center
Fort Worth, Texas 76107
United StatesSite Not Available
San Antonio VA
San Antonio, Texas 78201
United StatesActive - Recruiting
Seattle King County Health Department
Seattle, Washington 98101
United StatesActive - Recruiting
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