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Table 1 Summary of characteristics and conclusion of randomised controlled clinical trials using various regimens for TB prophylaxis in HIV

From: Current trends and intricacies in the management of HIV-associated pulmonary tuberculosis

Author Cohort characteristics Median CD4 Study design used in RCT No. enrolled Drugs used with dosages and duration Duration of follow up TB breakdown Conclusion
Samandari et al. [53] HIV infected With ART (47 %) if CD4 <200 cells/mm3 297 Double blind placebo controlled 1995 patients Arm A 6 months INH 300 mg daily +30 months placebo 36 months Arm A 1.26 %
Arm B-0.74 %
36 months INH was more effective but with greater toxicity
Arm B 6 months INH 300 mg daily +30 months INH daily
Swaminathan et al. [54] HIV infected With/without ART 320 Open labelled 683 patients Arm A 36 months of INH 300 mg daily 36 months Arm A 1.6/100py
Arm B-2.4/100py
Statistically similar efficacy and toxicity with 6EH7 and 36 INH. Emergence of resistance was 0.8 %
Arm B-6 months of INH 300 mg and Ethambutol 800 mg daily
Martinson et al. [55] HIV infected without ART and TST positive 484 Open labelled 1148 patients Arm A Rifapentine (900 mg) plus INH (900 mg) weekly for 12 weeks, Arm B Rifampin (600 mg) plus INH (900 mg) twice weekly for 12 weeks, Arm C INH (300 mg) daily for up to 6 years (continuous isoniazid) Arm D INH (300 mg) daily for 6 months (control group). Not specified Arm A-3.1/100py Arm-B 2.9/100py Arm-C 2.7/100py Arm-D-3.6/100py All regimens had equal efficacy w.r.t 6 months INH with toxicity more in the 3 years regimen. Emergence of resistance was 3.4 %
Sterling et al. [56] TBTC Study 26/ACTG 5259 [56] HIV infected with 30 % on ART or close contact of TB cases 500 Open labelled 399 patients Arm A 3 months of 900 mg (max) INH and 600–900 rifapentine once weekly Arm B 9 months of INH 300 mg daily 33 months Arm A-0.39/100py
Arm-B 1.25/100py
Both regimens had equivocal efficacy but more toxicity in 9 months of INH