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Study of Paroxetine and Fluconazole for the Treatment of HIV Associated Neurocognitive Disorder

NCT01354314 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-06-09

Study results available
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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.

Conditions

  • HIV Associated Neurocognitive Disorder

Interventions

DRUG

Fluconazole

One 100 MG capsule taken twice daily, 12 hour dosing

DRUG

Paroxetine

Two 10 MG capsules paroxetine once daily in the evening

DRUG

Paroxetine and Fluconazole

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

DRUG

Placebo

One capsule in the morning, three capsules in the evening

Sponsors & Collaborators

Principal Investigators

  • Ned Sacktor, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354314 on ClinicalTrials.gov