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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV Associated Neurocognitive Disorder

In brief

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.

Key facts

Study ID

NCT01354314

Run by

Johns Hopkins University

People needed

45

Starts

2010-11-01

Expected to finish

2016-03-01

Last updated by the study team

2017-06-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV+ based on ELISA and confirmed by either Western blot or plasma HIV RNA
• capable of providing informed consent
• age range: 18-65 years
• presence of neuropsychological testing impairment as defined by performance at least 1.0 standard deviation below age-matched and education-matched controls on three or more independent neuropsychological tests at the screening visit, or performance at least 2.0 standard deviations below age-matched and education-matched controls on one independent neuropsychological test and at least 1.0 standard deviation below age-matched and education-matched controls on a second independent neuropsychological test at the screening visit
• a stable HAART regimen for 3 months with no plans to change the antiretroviral regimen over the study period (confirmed by discussion with a patient's primary provider)
• the following lab values within 2 weeks prior to entry: hemoglobin > 8.9 g/dl, absolute neutrophil count > 500 cells/mm3, platelet count > 50,000 cells/mm3, ALT < 2.5 X upper limit of normal, alkaline phosphatase < 3 X upper limit of normal, serum creatinine >= 2 X upper limit of normal
• a negative serum or urine beta-HCG pregnancy test for all women of reproductive potential (have not reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation)
• neurological examination by a physician revealing no contraindication to a lumbar puncture. If an examination suggests a possible space-occupying brain mass lesion, neuroimaging with CT or MRI must confirm the absence of a mass lesion.

You may not qualify if…

• current or past opportunistic CNS infection (fungal or non-fungal) at study entry
• current systemic fungal infection
• current or past use of fluconazole within 30 days of the screening visit
• history or current clinical evidence of schizophrenia
• history of chronic neurological disorder such as multiple sclerosis or uncontrolled epilepsy
• active symptomatic AIDS defining opportunistic infection within 30 days prior to study entry
• history of abnormal medical illness or current severe affective disorder (e.g., depression with suicidal intention) which in the opinion of the investigators would constitute a safety risk for patients or interfere with the ability of a patient to complete the study
• treatment with anticoagulants including coumadin, heparin, or low molecular weight heparin which would be a contraindication for the lumbar puncture
• HIV+ individuals with moderate or severe confounding illnesses
• prior use of SSRI's within 1 month of screening
• active substance abuse (illicit drugs and/or controlled medications) or active severe alcohol abuse, evidenced by history intake or urine toxicology at any visit prior to study entry (starting study medication)

Where it is running

• The Johns Hopkins Institute for Clinical and Translational Research, Adult Outpatient Clinical Research Unit — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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