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

Samandari et al. [53]

HIV infected With ART (47 %) if CD4 <200 cells/mm³

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

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

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

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