| Methods | Randomized controlled trial Generation of allocation sequence: consecutive drawing of randomly generated treatment orders Allocation concealment: numbered opaque envelopes Blinding: investigator and assessor (though for the former blinding was weak, see notes) Inclusion of all randomized participants: 100% (25/25) and 96% (24/25) in the rifampicin and rifabutin arms |
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| Participants | Number enrolled: 50 Inclusion criteria: HIV‐positive tuberculosis patients with previously untreated disease; sputum smear positive; suggestive chest x‐ray Exclusion criteria included alcoholism |
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| Interventions | 1. Rifabutin: 150 mg if < 50 kg and 300 mg if > 50 kg daily for 6 months 2. Rifampicin: 450 mg if < 50 kg and 600 mg if > 50 kg daily for 6 months Companion drugs: isoniazid (300 mg daily for 6 months); pyrazinamide (1500 mg if < 50 kg and 2000 mg if > 50 kg daily for 2 months); and ethambutol (800 mg if < 50 kg and 1200 mg if > 50 kg daily for 2 months) |
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| Outcomes | 1. Smear status at 2 months 2. Time to sputum smear conversion | |
| Notes | Location: Kampala, Uganda Supervision: ambulatory treatment in majority from an early stage, observed only once or twice a week Follow up: sputum samples collected every 2 weeks during the initial phase of therapy; cultures also done but only at the time of smear conversion Other: only 42/50 participants ultimately had culture confirmation of their positive smear; 7 participants who had no culture confirmation of Mycobacterium tuberculosis complex infection due to contamination were included in the analysis Note on allocation concealment: no placebos were used and the treatments differed in formulation so that both participants and carers could potentially determine allocation No power calculation was presented for any outcome measure |
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