Objective: This clinical trial, carried out among injection drug users and the HIV-infected with tuberculin skin test ≥ 5 mm, aimed to evaluate the compliance and tolerability of two preventive strategies against tuberculosis (TB).
Methods: Study protocol prospectively compares adherence to nine months of daily therapy with isoniazid (9H) versus two months of daily therapy with rifampin plus pyrazinamide (2RZ) administered randomly. All patients were concurrently admitted to a methadone maintenance programme. To assess toxicity, liver function was monitored monthly.
Results: From 305 assessable patients, those in 2RZ arm showed better adherence (84% vs. 59%, p < 0.0001). Results on liver toxicity did not show significant differences between 9H and 2RZ (4.5% vs. 6.9%; odds ratio = 1.58, 95% confidence interval = 0.42—7.24). Conclusion: 2RZ should be considered an option to prevent TB in selected groups of patients infected with HIV, such as injection drug users on methadone treatment.
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