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

• Status: Completed
• Trial end date: 2017-11-14
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Isoniazid; Pyridoxal; Pyridoxine; Rifampin; Rifapentine; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• 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:

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 of normal (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 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 Criteria:

• 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