Fig 1.
a. Study flow for stage 1. b. Stage 2 cohorts. FCZ = fluconazole; AMB = amphotericin B; DLT = dose limiting toxicity; MTD = maximum tolerated dose; SMC = safety monitoring committee. Participants from Stage 1 for each of the 1600mg and 2000mg FCZ and AMB cohorts were combined with the participants from the Stage 2 group for the final safety and efficacy analysis.
Table 1.
Accrual of participants by induction dose and ACTG sites.
Table 2.
Baseline demographic, clinical and laboratory characteristics.
Table 3.
Baseline non-cryptococcal meningitis opportunistic infections and AIDS-defining conditions by Stage and treatment.
Fig 2.
* In the 1600mg FZ arm, 4/45 subjects switched to Ampho B and culture converted by week 10, An additional 5/45 started ampho B and subsequently died. In the 2000mg FZ arm 5/43 subjects switched to Ampho B and culture converted by week 10. An additional 3/43 started ampho B and subsequently died. In the Ampho B arm, 1/46 subjects switched to Fluconazole and culture converted by week 10.
Table 4.
Efficacy population: Cryptococcal CFU (Log10) at Weeks 0 and 2.
Fig 3.
Time to death (safety population).
Table 5.
Pairwise comparisons of FCZ with AMB.
Fig 4.
Time to progression of symptoms through end of study.
Table 6.
Causes of death.
Table 7.
List of grade 2 or worse adverse events through end of study.
Table 8.
Maximum DAIDS QTc* Grade of Visit or change from baseline.