Trial · NCT01802385

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

NCT01802385, Phase 3, Completed, University of Minnesota; results first posted 2020-01-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis. Trials, record NCT01802385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01802385

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
NCT number: NCT01802385
Status: Completed
Phases: Phase 3
Enrollment: 460 participants, actual
Lead sponsor: University of Minnesota
Conditions: Cryptococcal Meningitis, Fungal Meningitis
Interventions: Sertraline
First posted: 2013-03-01
Last updated: 2020-06-09
Results first posted: 2020-01-13

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Survival	18 weeks	18-week survival. The comparison will be between sertraline 400mg group and placebo
Secondary	Safety (Occurence of Adverse Events)	18 weeks	Safety and tolerability of adjunctive sertraline (grade 4-5) adverse reactions
Secondary	Count of Participants With Cerebrospinal Fluid Sterility	14 days	Number of participants with sterile cerebrospinal fluid at 2 weeks
Secondary	Center for Epidemiologic Studies in Depression (CES-D) Scale	14 weeks	Center for Epidemiologic Studies in Depression (CES-D) scale at 14 weeks. CES-D scores are based on a 20 item survey with total scores ranging from 0 to 60. Higher scores suggest a greater presence of depressive symptoms. A CES-D score of 16 or higher is interpreted to indicate a risk for depression.
Secondary	Quantitative Neurocognitive Performance Score (QNPZ-8)	14 weeks	Quantitative neurocognitive performance Z-score (QNPZ-8) at 14 weeks. The QNPZ-8 is a mean score of testing of 8 neurocognitive domains. Eqach domain is scaled based on a Z-score where the mean = 0 for the HIV-negative Ugandan population, accounting for age and educational status. Each +1 unit is one standard deviation better than the population norm. Each -1 unit is one standard deviation worse than the population norm.
Secondary	Fungal Clearance as Determined by Early Fungicidal Activity of CDF	14 days	To determine whether adjunctive sertraline will lead to a faster rate of fungal clearance from cerebrospinal fluid (CSF), as measured by early fungicidal activity (EFA) of clearance of the Cryptococcus colony forming units (cfu) per mL of CSF per day, compared to standard therapy alone.
Secondary	Number of Participants Experiencing IRIS OR Relapse	18 weeks	Cumulative incidence of central nervous system (CNS) cryptococcal-related paradoxical immune reconstitution inflammatory syndrome (IRIS) or culture-positive relapse
Secondary	Event Free Survival	18 weeks	Event free survival of composite events of: death,central nervous system (CNS) cryptococcal-related paradoxical immune reconstitution inflammatory syndrome (IRIS) or culture-positive relapse.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Survival	18 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Safety (Occurence of Adverse Events)	18 weeks	events	NUMBER
SECONDARY	Count of Participants With Cerebrospinal Fluid Sterility	14 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Center for Epidemiologic Studies in Depression (CES-D) Scale	14 weeks	score on a scale	MEAN
SECONDARY	Quantitative Neurocognitive Performance Score (QNPZ-8)	14 weeks	score	MEAN
SECONDARY	Fungal Clearance as Determined by Early Fungicidal Activity of CDF	14 days	-log10 CFU/ml/day	MEAN
SECONDARY	Number of Participants Experiencing IRIS OR Relapse	18 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Event Free Survival	18 weeks	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Survival	Placebo	125		Participants
Survival	Sertraline 400mg	109		Participants
Safety (Occurence of Adverse Events)	Placebo	121		events
Safety (Occurence of Adverse Events)	Sertraline 400mg	141		events
Count of Participants With Cerebrospinal Fluid Sterility	Placebo	90		Participants
Count of Participants With Cerebrospinal Fluid Sterility	Sertraline 400mg	101		Participants
Center for Epidemiologic Studies in Depression (CES-D) Scale	Placebo	16.6	95% Confidence Interval 14.3 to 18.8	score on a scale
Center for Epidemiologic Studies in Depression (CES-D) Scale	Sertraline 400mg	13.2	95% Confidence Interval 11.0 to 15.5	score on a scale
Quantitative Neurocognitive Performance Score (QNPZ-8)	Placebo	-1.4	95% Confidence Interval -1.5 to -1.2	score
Quantitative Neurocognitive Performance Score (QNPZ-8)	Sertraline 400mg	-1.3	95% Confidence Interval -1.4 to 1.1	score

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	231
Overall Study	STARTED	Sertraline 400mg	229
Overall Study	COMPLETED	Placebo	125
Overall Study	COMPLETED	Sertraline 400mg	109
Overall Study	NOT COMPLETED	Placebo	106
Overall Study	NOT COMPLETED	Sertraline 400mg	120

Source ClinicalTrials.gov

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Non-serious Adverse Events	General disorders	Placebo	65	231
other	Non-serious Adverse Events	General disorders	Sertraline 400mg	66	229
serious	Fever	General disorders	Placebo	4	231
serious	Fever	General disorders	Sertraline 400mg	1	229
serious	Infection	Infections and infestations	Placebo	3	231
serious	Infection	Infections and infestations	Sertraline 400mg	1	229
serious	Hypotension	General disorders	Placebo	1	231
serious	Hypotension	General disorders	Sertraline 400mg	2	229
serious	Thrombosis	Blood and lymphatic system disorders	Placebo	1	231
serious	Thrombosis	Blood and lymphatic system disorders	Sertraline 400mg	0	229

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	106	231
Total, all-cause mortality	Sertraline 400mg	120	229
Total, other adverse events	Placebo	65	231
Total, other adverse events	Sertraline 400mg	66	229
Total, serious adverse events	Placebo	121	231
Total, serious adverse events	Sertraline 400mg	141	229

Source ClinicalTrials.gov

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22508310	BACKGROUND	PubMed
26324276	BACKGROUND	PubMed
26971081	BACKGROUND	PubMed
30256903	DERIVED	PubMed
30325463	DERIVED	PubMed
30345376	DERIVED	PubMed
31242860	DERIVED	PubMed
31345462	RESULT	PubMed
32843994	DERIVED	PubMed
33677986	DERIVED	PubMed

1 to 10 of 13

See all 13 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01NS086312	Improving Diagnostics and Neurocognitive Outcomes in HIV/AIDS-related Meningitis	BOULWARE, DAVID R; MEYA, DAVID BISAGAYA	UNIVERSITY OF MINNESOTA	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2013 to 2025

Source NIH RePORTER

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sertraline 400mg vs Placebo: Number of Participants Experiencing IRIS OR Relapse	Trial comparisons
Sertraline 400mg vs Placebo: Count of Participants With Cerebrospinal Fluid Sterility	Trial comparisons
Sertraline 400mg vs Placebo: Event Free Survival	Trial comparisons
Sertraline 400mg vs Placebo: Survival	Trial comparisons
Sertraline 400mg vs Placebo: deaths from any cause	Trial comparisons
Sertraline 400mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01802385

GET https://conductscience.org/api/trials/v1/NCT01802385/events?page=2

API reference For AI assistants