Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

Completed · Phase 3

Conditions studied: Tuberculosis, HIV Infections

In brief

HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

Key facts

Study ID: NCT01404312
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 3000
Starts: 2012-05-23
Expected to finish: 2017-11-14
Last updated by the study team: 2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

HIV-1 infection
Tuberculin skin test (TST) reactivity greater than or equal to 5 mm or a positive interferon gamma release assay (IGRA) at any time prior to study entry, OR living in a high TB burden area. More information on this criterion can be found in the protocol.
Laboratory values obtained within 30 days prior to study entry:
Absolute neutrophil count (ANC) greater than 750 cells/mm\^3
Hemoglobin greater than or equal to 7.4 g/dL
Platelet count greater than or equal to 50,000/mm\^3
AST (SGOT) and ALT (SGPT) less than or equal to three times the upper limit of normal (ULN)
Total bilirubin less than or equal to 2.5 times the ULN
Chest radiograph or chest CT scan without evidence of active tuberculosis, unless one has been performed within 30 days prior to entry
Female participants of reproductive potential must have a negative serum or urine pregnancy test performed within 7 days prior to study entry. More information on this criterion can be found in the protocol.
All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization) while receiving RPT and for 6 weeks after stopping this drug
Female participants who are participating in sexual activity that could lead to pregnancy must agree to use one reliable non-hormonal form of contraceptive while receiving RPT and for 6 weeks after stopping this drug. More information on this criterion can be found in the protocol.
Weight of greater than or equal to 30 kg
Participant or legal guardian is able and willing to provide informed consent

You may not qualify if…

Treatment for active or latent TB (pulmonary or extrapulmonary) within 2 years prior to study entry or, at screening, presence of any confirmed or probable TB based on criteria listed in the current ACTG Diagnosis Appendix
History of multi-drug resistant (MDR) or extensively-drug resistant (XDR) TB at any time prior to study entry
Known exposure to MDR or XDR TB (e.g., household member of a person with MDR or XDR TB) at any time prior to study entry
Treatment for more than 14 consecutive days with a rifamycin or more than 30 consecutive days with INH at any time during the 2 years prior to enrollment
For participants taking antiretroviral therapy (ART) at study entry, only approved nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) or nevirapine (NVP) for at least 4 weeks were permitted
History of liver cirrhosis at any time prior to study entry.
Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and/or light stools within 90 days prior to study entry
Diagnosis of porphyria at any time prior to study entry
Peripheral neuropathy greater than or equal to Grade 2 according to the December 2004 (Clarification, August 2009) Division of AIDS (DAIDS) Toxicity Table, within 90 days prior to study entry
Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
Breastfeeding

Where it is running

University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program — La Jolla, California, United States
University of Southern California CRS — Los Angeles, California, United States
UCSD Antiviral Research Center CRS — San Diego, California, United States
Ucsf Hiv/Aids Crs — San Francisco, California, United States
Harbor-UCLA CRS — Torrance, California, United States
University of Colorado Hospital CRS — Aurora, Colorado, United States
Denver Public Health CRS — Denver, Colorado, United States
The University of Miami AIDS Clinical Research Unit (ACRU) CRS — Miami, Florida, United States
Northwestern University CRS — Chicago, Illinois, United States
Boston Medical Center CRS — Boston, Massachusetts, United States
Henry Ford Hosp. CRS — Detroit, Michigan, United States
Cooper Univ. Hosp. CRS — Camden, New Jersey, United States
New Jersey Medical School Clinical Research Center CRS — Newark, New Jersey, United States
Nyu Ny Nichd Crs — New York, New York, United States
Columbia P&S CRS — New York, New York, United States
Bronx-Lebanon Hospital Center NICHD CRS — The Bronx, New York, United States
Chapel Hill CRS — Chapel Hill, North Carolina, United States
Duke University Medical Center CRS — Durham, North Carolina, United States
Trinity Health and Wellness Center CRS — Dallas, Texas, United States
Houston AIDS Research Team CRS — Houston, Texas, United States
University of Washington AIDS CRS — Seattle, Washington, United States
Gaborone CRS — Gaborone, Botswana
Molepolole CRS — Gaborone, Botswana
Hospital Nossa Senhora da Conceicao CRS — Porto Alegre, Rio Grande do Sul, Brazil
Univ. of Sao Paulo Brazil NICHD CRS — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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