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

Inclusion Criteria:

• HIV-1 infection
• Tuberculin skin test (TST) reactivity greater than or equal to 5 mm or a positiveinterferon gamma release assay (IGRA) at any time prior to study entry, OR living in ahigh TB burden area. More information on this criterion can be found in the protocol.
• Laboratory values obtained within 30 days prior to study entry:

1. Absolute neutrophil count (ANC) greater than 750 cells/mm^3
2. Hemoglobin greater than or equal to 7.4 g/dL
3. Platelet count greater than or equal to 50,000/mm^3
4. AST (SGOT) and ALT (SGPT) less than or equal to three times the upper limit ofnormal (ULN)
5. Total bilirubin less than or equal to 2.5 times the ULN

• Chest radiograph or chest CT scan without evidence of active tuberculosis, unless onehas been performed within 30 days prior to entry
• Female participants of reproductive potential must have a negative serum or urinepregnancy test performed within 7 days prior to study entry. More information on thiscriterion can be found in the protocol.
• All participants must agree not to participate in a conception process (e.g., activeattempt 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 topregnancy must agree to use one reliable non-hormonal form of contraceptive whilereceiving RPT and for 6 weeks after stopping this drug. More information on thiscriterion 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 Criteria:

• Treatment for active or latent TB (pulmonary or extrapulmonary) within 2 years priorto study entry or, at screening, presence of any confirmed or probable TB based oncriteria listed in the current ACTG Diagnosis Appendix
• History of multi-drug resistant (MDR) or extensively-drug resistant (XDR) TB at anytime prior to study entry
• Known exposure to MDR or XDR TB (e.g., household member of a person with MDR or XDRTB) at any time prior to study entry
• Treatment for more than 14 consecutive days with a rifamycin or more than 30consecutive days with INH at any time during the 2 years prior to enrollment
• For participants taking antiretroviral therapy (ART) at study entry, only approvednucleoside 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/orlight 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 daysprior to study entry
• Known allergy/sensitivity or any hypersensitivity to components of study drugs ortheir formulation
• Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements
• Serious illness requiring systemic treatment and/or hospitalization within 30 daysprior to study entry
• Breastfeeding