Study | Method | Participants | Interventions | Primary outcome(s) | Setting | Disease severity | Overall risk of bias | Narrative of efficacy findings (95% CIs) | Narrative of safety findings |
ACTG120, 1992 | Single arm trial | 59 with PDH | ITRA 300 mg BD for 3 days then 200 mg BD for 12 weeks | "Response to therapy" Death |
USA | Mild to moderate | Serious |
Clinical success: 50/59 participants 85% (73% to 93%) Death: 1/59 |
2/59 participants withdrew due to adverse events, and responded to AmB. |
ACTG174, 1994 | Single arm trial | 49 with PDH |
Initial protocol FCN 1200 mg, then 600 mg OD for 8 weeks Revised protocol FCN 1200 mg, then 80 mg OD for 8 weeks |
"Treatment response" | USA | Mild to moderate | Serious |
Clinical success: 36/49 participants. 74% (59% to 85%) Revised protocol |
2 discontinuations due to toxicity, unclear if induction or maintenance. |
Johnson 2002 | RCT | 81 with PDH | lAmB (55 participants) dAmB (26 participants) |
Efficacy: "Clinical success" Safety: early discontinuation |
USA | Moderate to severe | Low |
Clinical success: lAmB: 82% (69% to 91%) 45/55 participants. dAmB: 56% (37% to 76%) 14/25 participants. RR 1.46 (1.01 to 2.11) Death: lAmB: 1/53 (2%) dAmB: 3/24 (13%) RR 0.15 (0.02 to 1.38) |
Early discontinuation: 1/53 (2%) with lAmB vs 2/24 (8%) with dAmB RR 0.23 (95% CI 0.02 to 2.38) Nephrotoxicity: 5/53 (9%) with lAmB vs 9/24 (37%) with dAmB RR 0.25 (95% CI 0.09 to 0.67) Of note, authors did not report specific data in relation to other commonly recognized adverse effects, including anaemia. |
Luckett 2015 | Retrospective cohort study | 56 with HIV and PDH | ITRA/VORI/POSA AmB |
Death (90‐day histoplasmosis‐related) Triazole failure |
USA | Mild to severe | Serious |
Death 5/56 participants. Not reported by treatment regimen. Clinical success: triazole induction successful in 20/24 participants 83% (62% to 95%) |
No safety issues reported. |
AmB: amphotericin B; BD: twice daily; CI: confidence interval; dAmB: deoxycholate amphotericin B; FCN: fluconazole; ITRA: itraconazole; IAmB: liposomal amphotericin B; n: number of participants; OD: once daily; PDH: progressive disseminated histoplasmosis; POSA: posaconazole; RCT: randomized controlled trial; RR: risk ratio; VORI: voriconazole. |