Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection

Completed · Phase 3

Conditions studied: Tuberculosis

In brief

Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).

Key facts

Study ID

NCT00023452

Run by

Centers for Disease Control and Prevention

People needed

8053

Starts

2001-06-01

Expected to finish

2013-09-01

Last updated by the study team

2024-08-27

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or nonpregnant, non-nursing females > 2 years old.
• Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as:
• Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as > 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as > 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique.
• TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of > 10 mm within two years of a nonreactive test or persons with an increase of > 10 mm 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 prior history of TB treatment, > 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report.
• HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible.
• Willing to provide signed informed consent, or parental consent and participant assent.

You may not qualify if…

• 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 > 30 consecutive days with INH during the previous 2 years.
• A documented history of a completing an adequate course of treatment for active TB or 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 among persons in whom AST is determined
• Pregnant or nursing females
• Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment.
• Weight < 10.0 kg

Where it is running

• Central Arkansas Veterans Health System — Little Rock, Arkansas, United States
• LA County/USC Medical Center — Los Angeles, California, United States
• UCSD Medical Center — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Denver Department of Public Health and Hospitals — Denver, Colorado, United States
• Washington, D.C. VAMC — Washington D.C., District of Columbia, United States
• Emory University, Department of Medicine — Atlanta, Georgia, United States
• Chicago VA Medical Center (Lakeside) — Chicago, Illinois, United States
• Hines VA Medical Center — Hines, Illinois, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• New Jersey Medical School — Newark, New Jersey, United States
• Columbia University/Presbyterian Medical Center — New York, New York, United States
• Harlem Hospital Center — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of North Texas Health Science Center — Fort Worth, Texas, United States
• Michael Debakey Veterans Affairs Medical Center — Houston, Texas, United States
• Audi L. Murphy VA Hospital — San Antonio, Texas, United States
• Seattle King County Health Department — Seattle, Washington, United States
• Universidade Federal do Rio de Janeiro — Rio de Janeiro, Brazil
• University of British Columbia — Vancouver, British Columbia, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• Montreal Chest Institute McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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