CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Fluconazole +3 moredrug
Likely dose
Fluconazole 100 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01354314
NCT01354314Phase 2Completed
CompareCT.gov

Pilot Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder (HAND)

Johns Hopkins University·interventional·Posted May 16, 2011·Updated Jun 9, 2017

In Brief

A Phase 2 clinical trial evaluating Fluconazole, Paroxetine, and 2 other interventions for HIV Associated Neurocognitive Disorder. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Associated Neurocognitive Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2011
Enrollment StartNov 1, 2010
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.1 years ago

Interventions

Fluconazoledrug

One 100 MG capsule taken twice daily, 12 hour dosing

Paroxetinedrug

Two 10 MG capsules paroxetine once daily in the evening

Paroxetine and Fluconazoledrug

One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening

Placebodrug

One capsule in the morning, three capsules in the evening