Phase 3
N=460
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
Cryptococcal Meningitis · Fungal Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT01802385 ↗Enrolled (actual)
460
Serious AEs
57.0%
Results posted
Jan 2020
Primary outcome: Primary: Survival — 125; 109 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sertraline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
125; 109 | — |
| SECONDARY Safety (Occurence of Adverse Events) |
121; 141 | — |
| SECONDARY Count of Participants With Cerebrospinal Fluid Sterility |
90; 101 | — |
| SECONDARY Center for Epidemiologic Studies in Depression (CES-D) Scale |
16.6; 13.2 | — |
| SECONDARY Quantitative Neurocognitive Performance Score (QNPZ-8) |
-1.4; -1.3 | — |
| SECONDARY Fungal Clearance as Determined by Early Fungicidal Activity of CDF |
0.47; .43; 0.33; .33 | — |
| SECONDARY Number of Participants Experiencing IRIS OR Relapse |
9; 5 | — |
| SECONDARY Event Free Survival |
116; 103 | — |
Summary
This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival.
There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172 persons conducted from August 2013 to August 2014. See NCT03002012.
Eligibility Criteria
Inclusion Criteria
- Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)
- HIV-1 infection
- Ability and willingness of the participant or legal guardian/representative to provide informed consent
- Willing to receive protocol-specified lumbar punctures
Exclusion Criteria
- Age =3 doses of amphotericin therapy
- Cannot or unlikely to attend regular clinic visits
- History of known liver cirrhosis
- Presence of jaundice
- Pregnancy
- Current breastfeeding
Data sourced from ClinicalTrials.gov (NCT01802385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.