Evidence map›Paper›PMID 29063516›Full record

Trial reportJournal of neurovirology2018

Paroxetine and fluconazole therapy for HIV-associated neurocognitive impairment: results from a double-blind, placebo-controlled trial.

Ned Sacktor, Richard L Skolasky, Richard Moxley, Sheng Wang, Michelle M Mielke, Cynthia Munro, Joseph Steiner, Avindra Nath, Norman Haughey, Justin McArthur

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurovirology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
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  14. Review
  15. Review
  16. Fluconazole Is Neuroprotective via Interactions with the IGF-1 Receptor.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Article
  17. Review
  18. Review
  19. CNS Neurotoxicity of Antiretrovirals.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2021
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Ned SacktorJohns Hopkins University School of Medicine, Baltimore, MD, USA. sacktor@jhmi.edu.ORCID 0000-0001-5349-8058
Richard L SkolaskyJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Richard MoxleyJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Sheng WangJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Michelle M MielkeDepartments of Health Science Research and Neurology, Mayo Clinic, Rochester, MN, USA.
Cynthia MunroJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Joseph SteinerNational Institutes of Health, Bethesda, MD, USA.
Avindra NathNational Institutes of Health, Bethesda, MD, USA.
Norman HaugheyJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Justin McArthurJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Johns Hopkins University · USNational Institutes of Health · USMayo Clinic in Florida · US

Funding

Neuropathogenesis of Retroviral InfectionsZIANS003130 · NINDS · NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE · PI NATH, AVINDRA · 2011 to 2025
$73.7M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Therapeutic CoreP30MH075673 · NIMH · JOHNS HOPKINS UNIVERSITY · PI Barbara Stauch Slusher · 2006 to 2026
$33.2M
Translational Research in Neuro-AIDS and Mental HealthR25MH080661 · NIMH · JOHNS HOPKINS UNIVERSITY · PI MCARTHUR, JUSTIN CHARLES. · 2007 to 2019
$2.9M
NCATS NIH HHS UL1 TR001079NIMH NIH HHS P30 MH075673NIMH NIH HHS R25 MH080661
6 · The paper itself

Abstract

Paroxetine and fluconazole have neuroprotective effects in an in vitro model of HIV protein-mediated neuronal injury. This study evaluated the safety, tolerability, and efficacy of both paroxetine and fluconazole for the treatment of HIV-associated neurocognitive disorder (HAND). A 24-week randomized double-blind, placebo-controlled 2 × 2 factorial design study was used. HIV+ individuals with cognitive impairment were enrolled in the 24-week trial. Participants were randomly assigned to one of four groups: (1) paroxetine 20 mg/day, (2) fluconazole 100 mg every 12 h, (3) paroxetine and fluconazole, or (4) placebo. Safety, tolerability, and efficacy were evaluated. Forty-five HIV+ individuals were enrolled. Medications were well tolerated. Compared to no paroxetine arms, HIV+ individuals receiving paroxetine showed improved NPZ8 summary scores, (mean change = 0.25 vs - 0.19, p = 0.049), CalCAP sequential test reaction time (mean change = 0.34 vs -0.23, p = 0.014), Trail Making Part B test performance (mean change = 0.49 vs - 0.33, p = 0.041), and FAS verbal fluency (mean change = 0.25 vs 0.02, p = 0.020) but a decline in the Letter number sequencing test (mean change = - 0.40 vs 0.26, p = 0.023). Biomarkers of cellular stress, inflammation, and neuronal damage were not affected by paroxetine. HIV+ individuals receiving fluconazole did not show a benefit in cognition and showed an increase in multiple markers of cellular stress compared to the no fluconazole arms. In conclusion, paroxetine was associated with improvement in a summary neuropsychological test measure and in several neuropsychological tests but worse performance in one neuropsychological test. Further studies of paroxetine for the treatment of HAND and to define its precise neuroprotective properties are warranted.

Indexed as

AdultAIDS Dementia ComplexAntidepressive Agents, Second-GenerationAntifungal AgentsAnti-HIV AgentsDouble-Blind MethodDrug Administration ScheduleDrug RepositioningFactor Analysis, StatisticalFemaleFluconazoleHIV-1HumansMaleMiddle AgedNeuroprotective AgentsAntidepressive Agents, Second-GenerationAntifungal AgentsAnti-HIV AgentsFluconazoleNeuroprotective AgentsParoxetineCognitive impairmentFluconazoleHIVParoxetine

Identifiers

PMID29063516
PMCPMC5792316
OpenAlexW2766800316

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.