6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial.

摘要: Summary Background In accordance with WHO guidelines, people HIV infection in Botswana receive daily isoniazid preventive therapy against tuberculosis without obtaining a tuberculin skin test, but duration of prophylaxis is restricted to 6 months. We aimed assess effectiveness extended therapy. Methods our randomised, double-blind, placebo-controlled trial we enrolled adults infected aged 18 years or older at government HIV-care clinics Botswana. Exclusion criteria included current illness such as cough and an abnormal chest radiograph antecedent pneumonia. Eligible individuals were randomly allocated (1:1) months' open-label followed by 30 masked placebo (control group) (continued on the basis computer-generated randomisation list permuted blocks ten each clinic. Antiretroviral was provided if participants had CD4-positive lymphocyte counts fewer than 200 cells per μL. used Cox regression analysis log-rank test compare incident groups. models estimate effect antiretroviral The registered ClinicalTrials.gov, number NCT00164281. Findings Between Nov 26, 2004, July 3, 2009, recorded 34 (3·4%) cases 989 control group 20 (2·0%) 1006 continued (incidence 1·26% year vs 0·72%; hazard ratio 0·57, 95% CI 0·33–0·99, p=0·047). Tuberculosis incidence those receiving escalated approximately days after completion isoniazid. Participants who positive (ie, ≥5 mm induration) enrolment received substantial benefit from treatment (0·26, 0·09–0·80, p=0·02), whereas test-negative no significant (0·75, 0·38–1·46, p=0·40). By study completion, 946 (47%) 1995 initiated reduced 50% 360 compared (adjusted 0·50, 0·26–0·97). Severe adverse events death much same Interpretation tuberculosis-endemic setting, 36 more effective for prevention 6-month infection, chiefly benefited positive. Funding US Centers Disease Control Prevention Agency International Development.