RIFAPENDINE/ISONIAZID FOR 3 MONTHS VS 9 MO FOR LATENT TB (STUDY 26) (HIV)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: The primary objective is to evaluate the effectiveness of a three-month, 12-dose regimen of weekly rifapentine plus isoniazid (3RPT/INH) compared to the effectiveness of a nine-month, 270 dose regimen of daily isoniazid (9INH) in preventing TB in high-risk tuberculin skin-test reactors. Secondary objectives are: to compare the rates of drug discontinuation due to adverse drug reactions or for any reason associated with 3RPT/INH and 9INH; to compare the rates of any grade 3, 4, or 5 drug toxicity associated with 3RPT/INH and 9INH; to compare treatment completion rates of 3RPT/INH and 9INH; to compare the efficacy of 3RPT/INH and 9INH among persons who complete study-phase therapy; to compare the effectiveness and tolerability of 3RPT/INH and 9INH in HIV-infected persons; to compare the rates of methadone withdrawal associated with 3RPT/INH and 9INH among persons concomitantly receiving methadone; and to describe patterns of antibiotic resistance among Mycobacterium tuberculosis isolates in patients who develop tuberculosis despite treatment of latent infection. RESEARCH PLAN: This trial will be conducted among high-risk tuberculin skin-test reactors, including HIV-infected persons, who require treatment of latent infection to prevent tuberculosis. We do not plan to enroll children or adolescents under the age of 18 at this site. The weekly rifapentine (900 mg for persons weighing more than 50 kg or 750 mg for persons weighing 50 kg or less) and isoniazid (15 mg/kg) regimen will be given under direct observation and the daily isoniazid (5 mg/kg) regimen will be primarily self-administered. Pyridoxine (vitamin B6) 50 mg will be given with each dose of isoniazid in both study arms. Close contacts will be randomized by household; others will be randomized individually. All participants will be followed for 33 months after initiation of study-phase therapy. Subjects will be seen every four weeks during study-phase therapy. Post-therapy follow-up will occur every three months until 21 months after enrollment, and every six months thereafter. METHODS: This is an open-label, multi-center, prospective, randomized study to evaluate the effectiveness of 3RPT/INH compared to the effectiveness of 9INH conducted among high-risk tuberculin skin-test reactors who require treatment of latent infection to prevent tuberculosis.