NCT01802385.
Trial name or title | Adjunctive sertraline for the treatment of HIV‐associated cryptococcal meningitis (ASTRO‐CM) |
Methods | Phase 3 RCT |
Participants | ≥ 18 years of age with HIV‐associated cryptococcal meningitis |
Interventions | 2 weeks of AmBd 0.7 to 1.0 mg/kg/day and FLU 800 to 1200 mg/day plus sertraline 400 mg/day for 2 weeks then sertraline 200 mg/day for 12 weeks then tapered over 3 weeks versus 2 weeks of AmBd 0.7 to 1.0 mg/kg/day and FLU 800 to 1200 mg/day |
Outcomes | Primary: 18‐week survival |
Starting date | 2015 |
Contact information | david.meya@gmail.com |
Notes | Study terminated during interim monitoring for futility, results not published in peer‐reviewed journal but presented at Conference on Retroviruses and Opportunistic Infections 2018. |
Abbreviations: 5FC: flucytosine; AmBd: amphotericin B deoxycholate; CSF: cerebrospinal fluid; FLU: fluconazole; IV: intravenous; L‐AmB: liposomal amphotericin; RCT: randomized controlled trial