Trial · NCT01354314
Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder
NCT01354314, Phase 1, Phase 2, Completed, Johns Hopkins University; results first posted 2017-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder. Trials, record NCT01354314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01354314
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder
- NCT number
- NCT01354314
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- HIV Associated Neurocognitive Disorder
- Interventions
- Fluconazole, Paroxetine, Paroxetine and Fluconazole, Placebo
- First posted
- 2011-05-16
- Last updated
- 2017-06-09
- Results first posted
- 2017-05-12
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat | 24 Weeks | CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis). |
| Primary | Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol | 24 Weeks | CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis). |
| Primary | Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat | 24 Weeks | CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for all participants for whom CSF data are available (intent to treat analysis). |
| Primary | Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol | 24 Weeks | CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for participants with 90% or greater adherence to study drug and for whom CSF data are available (per protocol analysis). |
| Secondary | Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat | 24 Weeks | CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis). |
| Secondary | Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol | 24 Weeks | CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis). |
| Secondary | Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat | 24 Weeks | CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis). |
| Secondary | Change in CSF CD163 Between Baseline and Week 24 - Per Protocol | 24 Weeks | CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis). |
| Secondary | Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat | 24 Weeks | CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis). |
| Secondary | Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol | 24 Weeks | CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis). |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat | 24 Weeks | 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures. | ng/mL | MEDIAN |
| PRIMARY | Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol | 24 Weeks | For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures. | ng/mL | MEDIAN |
| PRIMARY | Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat | 24 Weeks | For intention to treat analysis, 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures. | pi*mm^2 | MEDIAN |
| PRIMARY | Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol | 24 Weeks | For per protocol analysis, 18 participants (out of the total 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures. | pi*mm^2 | MEDIAN |
| SECONDARY | Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat | 24 Weeks | 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures. | pg/mL | MEDIAN |
| SECONDARY | Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol | 24 Weeks | For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures. | pg/mL | MEDIAN |
| SECONDARY | Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat | 24 Weeks | 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures. | ng/mL | MEDIAN |
| SECONDARY | Change in CSF CD163 Between Baseline and Week 24 - Per Protocol | 24 Weeks | For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures. | ng/mL | MEDIAN |
| SECONDARY | Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat | 24 Weeks | 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures. | pg/mL | MEDIAN |
| SECONDARY | Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol | 24 Weeks | For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures. | pg/mL | MEDIAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat | Paroxetine and Fluconazole | -30.78 | Inter-Quartile Range -68.27 to 24.71 | ng/mL | |
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat | Paroxetine | 4.16 | Inter-Quartile Range -38.76 to 47.95 | ng/mL | |
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat | Fluconazole | -12.17 | Inter-Quartile Range -56.98 to 9.81 | ng/mL | |
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat | Placebo | -30.56 | Inter-Quartile Range -65.78 to 59.94 | ng/mL | |
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol | Paroxetine and Fluconazole | -51.35 | Inter-Quartile Range -119.66 to 5.95 | ng/mL | |
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol | Paroxetine | 34.11 | Inter-Quartile Range -4.71 to 51.20 | ng/mL | |
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol | Fluconazole | -65.00 | Inter-Quartile Range -69.00 to -60.99 | ng/mL | |
| Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol | Placebo | -52.37 | Inter-Quartile Range -87.89 to -7.96 | ng/mL | |
| Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat | Paroxetine and Fluconazole | 6.392 | Inter-Quartile Range -14.214 to 11.674 | pi*mm^2 | |
| Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat | Paroxetine | 12.235 | Inter-Quartile Range -23.502 to 30.271 | pi*mm^2 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paroxetine and Fluconazole | 12 | |
| Overall Study | STARTED | Paroxetine | 11 | |
| Overall Study | STARTED | Fluconazole | 11 | |
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | Completed (ITT) | Paroxetine and Fluconazole | 11 | |
| Overall Study | Completed (ITT) | Paroxetine | 11 | |
| Overall Study | Completed (ITT) | Fluconazole | 9 | |
| Overall Study | Completed (ITT) | Placebo | 10 | |
| Overall Study | COMPLETED | Paroxetine and Fluconazole | 6 | |
| Overall Study | COMPLETED | Paroxetine | 8 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events256
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal cramping or pain | Gastrointestinal disorders | Paroxetine and Fluconazole | 0 | 12 | 0 |
| other | Abdominal cramping or pain | Gastrointestinal disorders | Paroxetine | 1 | 11 | 1 |
| other | Abdominal cramping or pain | Gastrointestinal disorders | Fluconazole | 1 | 11 | 1 |
| other | Abdominal cramping or pain | Gastrointestinal disorders | Placebo | 1 | 11 | 1 |
| other | Absolute neutrophil count (ANC), low | Immune system disorders | Paroxetine and Fluconazole | 0 | 12 | 0 |
| other | Absolute neutrophil count (ANC), low | Immune system disorders | Paroxetine | 0 | 11 | 0 |
| other | Absolute neutrophil count (ANC), low | Immune system disorders | Fluconazole | 0 | 11 | 0 |
| other | Absolute neutrophil count (ANC), low | Immune system disorders | Placebo | 1 | 11 | 2 |
| other | Acute bronchospasm | Respiratory, thoracic and mediastinal disorders | Paroxetine and Fluconazole | 0 | 12 | 0 |
| other | Acute bronchospasm | Respiratory, thoracic and mediastinal disorders | Paroxetine | 0 | 11 | 0 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paroxetine and Fluconazole | 0 | 12 |
| Total, all-cause mortality | Paroxetine | 0 | 11 |
| Total, all-cause mortality | Fluconazole | 0 | 11 |
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, other adverse events | Paroxetine and Fluconazole | 11 | 12 |
| Total, other adverse events | Paroxetine | 10 | 11 |
| Total, other adverse events | Fluconazole | 10 | 11 |
| Total, other adverse events | Placebo | 10 | 11 |
| Total, serious adverse events | Paroxetine and Fluconazole | 2 | 12 |
| Total, serious adverse events | Paroxetine | 0 | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30MH075673 | JHU Center for the Advancement of HIV Neurotherapeutics (JHU CAHN) | RUBIN, LEAH HELANE; SLUSHER, BARBARA STAUCH | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2006 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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/NCT01354314
GET https://conductscience.org/api/trials/v1/NCT01354314/registered?page=2