Completed

ASTRO-CMAdjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

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What is being tested

Sertraline

Drug
Who is being recruted

Neuroinflammatory Diseases+9

+ Bacterial Infections and Mycoses

+ Central Nervous System Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2015
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: June 9, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: March 9, 2015

Actual date on which the first participant was enrolled.

This is a phase III randomized trial to evaluate whether sertraline when added to standard amphotericin-based therapy for cryptococcal meningitis, will lead to improved survival . Cryptococcal meningitis diagnosis will be made via CSF cryptococcal antigen (CRAG) at time of lumbar puncture (LP) with confirmation by CSF culture. After informed consent, subjects that meet eligibility requirements will be able to enter study. A non-randomized phase I dose-escalation study will first be conducted to help optimize dosing for a larger randomized phase II study. Phase III Design: Subjects will be randomized to standard induction therapy with masked placebo or sertraline at 400mg/day. We will use a permutated block randomization in a 1:1 allocation (n=275 per arm). Total anticipated enrollment: 550 subjects.

NCT01802385
Principal SponsorUniversity of Minnesota
Last updated: June 9, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

460 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neuroinflammatory DiseasesBacterial Infections and MycosesCentral Nervous System DiseasesCentral Nervous System InfectionsCryptococcosisInfectionsMycosesNervous System DiseasesCentral Nervous System Fungal InfectionsMeningitisMeningitis, CryptococcalMeningitis, Fungal

Criteria

4 inclusion criteria required to participate
Ability and willingness of the participant or legal guardian/representative to provide informed consent
Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)
HIV-1 infection
Willing to receive protocol-specified lumbar punctures
7 exclusion criteria prevent from participating
Age < 18 years
Cannot or unlikely to attend regular clinic visits
Current breastfeeding
History of known liver cirrhosis
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day) + placebo

Group II

Experimental
Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day plus adjunctive sertraline therapy at 400mg/day for 2 weeks, then 200mg for 12 weeks, and then tapered over 3 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Infectious Disease Institute

Kampala, UgandaOpen Infectious Disease Institute in Google Maps

Mbarara University of Science and Technology

Mbarara, Uganda
Completed2 Study Centers