Status:
COMPLETED
Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Tuberculosis
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The World Health Organization (WHO) estimated that in 2017 there were 10 million new cases of TB, and 1.6 million people died as a result of TB. Among new TB cases, it is estimated that 920,000 occurr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2017
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01404312
Start Date
May 23 2012
End Date
November 14 2017
Last Update
November 4 2021
Active Locations (45)
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1
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
La Jolla, California, United States, 92093-0672
2
University of Southern California CRS
Los Angeles, California, United States, 90033-1079
3
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
4
Ucsf Hiv/Aids Crs
San Francisco, California, United States, 94110