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Design
Randomised (allocation concealed*), blinded (clinicians and patients),* placebo controlled trial with median 10.5 month follow up.
Setting
4 outpatient tuberculosis treatment centres in Abidjan, Côte d'Ivoire.
Patients
771 patients (mean age 32 y, 60% men) who had sputum smears positive for tuberculosis, were HIV-1 positive, or dually reactive for HIV-1 and HIV-2, and met laboratory eligibility criteria (haemoglobin level
70 g/l, granulocyte count >1.1x109/l, platelet count >100x109/l, serum alanine aminotransferase level <2.5 times the upper limit of normal, and serum creatinine concentration <150 g/l). Exclusion criteria were positivity for HIV-2, pregnancy, previously treated tuberculosis, allergy to co-trimoxazole, or receipt of co-trimoxazole to prevent recurrent toxoplasmosis. 764 patients (99%) were included in the analysis.
Intervention
Patients were allocated to 1 tablet daily of trimethoprim, 160 mg, and sulfamethoxazole, 800 mg (n=386), or placebo (n=385). All patients received tuberculosis medication for 6 months.
Main outcome measures
Death and
1 hospitalisation.
Main results
85%
Manjula Datta, MD, Dch, MSc
Tamil Nadu Dr M G R Medical University Chennai, Tamil Nadu, India
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