Phase 3
Completed N=460
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
Cryptococcal Meningitis · Fungal Meningitis
Source: ClinicalTrials.gov NCT01802385 ↗
Enrolled (actual)
460
Serious AEs
57.0%
Results posted
Jan 2020
Primary outcomePrimary: Survival — 125; 109 Participants
◆ Published Evidence
Highly cited
127citations · ~18 / year
Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomised, placebo-controlled, double-blind phase 3 trial.
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.
Linked Publications (5)
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Adjunctive sertraline for HIV-associated cryptococcal meningitis: a randomised, placebo-controlled, double-blind phase 3 trial.
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Recurrence of Symptoms Following Cryptococcal Meningitis: Characterizing a Diagnostic Conundrum With Multiple Etiologies.
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Divergent neuroimmune signatures in the cerebrospinal fluid predict differential gender-specific survival among patients with HIV-associated cryptococcal meningitis.
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Short Communication: A Descriptive Analysis of Dried Blood Spot Adherence Testing Among Ugandans with HIV Presenting with Cryptococcal Meningitis.
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Experiences, challenges, gaps, and strategies for counselling persons presenting with advanced HIV-associated meningitis in Uganda.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.