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Table 1 Characteristics of 5 randomized controlled trials of primary prophylaxis against Mycobacterium avium complex in HIV-infected adults

From: Drug efficacy by direct and adjusted indirect comparison to placebo: An illustration by Mycobacterium avium complex prophylaxis in HIV

Study Drug dose No. subjects Mean CD4 Count a (cells/μl) % On ART Median Follow-up time b (days) Primary MAC events (N) Direct monthly failure rate (95% CI) Direct monthly probability
of failure
Nightingale 1993, study 023 and 027c[13] Rifabutin, 300 mg, qd 283 64 100 209 d 24 0.012 (0.007-0.017) 0.012
  Placebo 290 56 100 202 d 51 0.027 (0.019-0.0034) 0.026
Havlir 1996[17] Rifabutin, 300 mg, qd 223 47 -- 514 52 0.014 (0.010-0.018) 0.014
  Azithromycin, 1200 mg, qwk 223 49 -- 514 31 0.008 (0.005-0.011) 0.008
Benson 2000[16] Rifabutin, 300 e mg, qd 391 30 75 574 59 0.008 (0.006-0.010) 0.008
  Clarithromycin, 500 mg, bid 398 27 73 595 36 0.005 (0.003-0.006) 0.005
Pierce 1996[14] Clarithromycin, 500 mg, bid 333 30 -- 427 f 19 0.004 (0.002-0.006) 0.004
  Placebo 334 25 -- 402 f 53 0.012 (0.009-0.015) 0.012
Oldfield 1998[15] Azithromycin, 1200 mg, qwk 85 44 -- 400 d 9 g 0.008 (0.003-0.013) 0.008
  Placebo 89 44 -- 340 d 24 g 0.024 (0.015-0.034) 0.024
  1. qd: once a day; bid: twice a day; qwk: once a week; MAC: Mycobacterium avium complex; ART: antiretroviral therapy; CI: confidence interval
  2. a At baseline
  3. b All patients on ART were on dual or mono therapy
  4. c Study 023 and 027 are two identically designed studies. We calculated weighted averages the number of subjects, follow-up time, and number of new MAC events for the two studies.
  5. d Duration on treatment
  6. e This study was originally designed with a 450 mg qd dosage but reduced to 300 mg qd after 9 months.
  7. f Mean follow-up time
  8. g The primary endpoints of this study were MAC symptoms and positive culture. We only included culture-positive events, to remain consistent with the other studies, which all used positive MAC cultures as primary endpoints.