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NCT01354314 · ClinicalTrials.gov registry record · Phase 1
Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01354314: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT01354314 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01354314, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a treatment for problems with memory, concentration, thinking, and judgment in people who are infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major depression. Fluconazole is an antifungal medication approved by the FDA to treat fungal infections.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Fluconazole
- DRUG Paroxetine
- DRUG Paroxetine and Fluconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2010-11 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT01354314 record still lists
NCT01354314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01354314 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01354314 about?
NCT01354314 is a clinical study titled "Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder". The purpose of this study is to see if paroxetine and fluconazole are safe and effective as a treatment for problems with memory, concentration, thinking, and judgment in people who are infected with HIV. Paroxetine is an antidepressant approved by the FDA to treat major depression. Fluconazole is a...
What is the current status of trial NCT01354314?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2010-11. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01354314?
The interventions under investigation include: Placebo (DRUG), Fluconazole (DRUG), Paroxetine (DRUG), Paroxetine and Fluconazole (DRUG).
Who is sponsoring clinical trial NCT01354314?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01354314's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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