Evidence map›Paper›PMID 20032007›Full record

Trial reportThe Journal of antimicrobial chemotherapy2010

Co-administration of fluconazole increases nevirapine concentrations in HIV-infected Ugandans.

Katie Wakeham, Rosalind Parkes-Ratanshi, Victoria Watson, Abu-Baker Ggayi, Saye Khoo, David G Lalloo

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Effect ofAIDS research and therapy · 2017
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Safety, censoring, and intent-to-treat analysis: dangers to generalizability.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2010
    Article
  10. Review
  11. Treatment of cryptococcal meningitis in resource limited settings.Current opinion in infectious diseases · 2009
    Review
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

6 authors at 4 institutions in 2 countries.

Katie WakehamMRC/UVRI Uganda Research Unit on AIDS, PO Box 49, Entebbe, Uganda. katie.wakeham@mrcuganda.org
Rosalind Parkes-Ratanshi
Victoria Watson
Abu-Baker Ggayi
Saye Khoo
David G Lalloo
Liverpool School of Tropical Medicine · GBUganda Virus Research Institute · UGRoyal Liverpool and Broadgreen University Hospital NHS Trust · GBUniversity of Liverpool · GB

Funding

Medical Research Council G0100035Medical Research Council G0601028
6 · The paper itself

Abstract

backgroundData from retrospective studies have suggested that there may be an interaction between fluconazole and nevirapine, increasing nevirapine concentrations and potentially leading to hepatotoxicity.

methodsThis study was nested within a large double-blind placebo-controlled study designed to determine if primary prophylaxis with fluconazole (200 mg three times per week) could reduce cryptococcal disease [CRYPTOPRO (ISRCTN 76481529)] in HIV-infected adults in rural south-western Uganda. Detailed pharmacokinetic studies were performed on 49 participants (22 on placebo and 27 on fluconazole) who had been on fluconazole or placebo with nevirapine for > or =4 weeks.

resultsThe geometric mean pre-dose concentrations of nevirapine were 3865 ng/mL [95% confidence interval (95% CI) 3452-4758 ng/mL] and 5141 ng/mL (95% CI 4760-6595 ng/mL) (P = 0.009) in the placebo and fluconazole arms, respectively. The change in the peak nevirapine concentration in plasma (C(max)) was also higher in the fluconazole arm compared with the placebo arm [median 6546 (95% CI 6040-7974) versus 5126 (95% CI 4739-5773) ng/mL, P = 0.012]. Fluconazole increased the nevirapine area under the curve (AUC) from 0 to 8 h by 29% [geometric mean AUC(0-8) 46 135 (95% CI 42 432-57 173) versus 35 871 (95% CI 32 808-41 372) ng.h/mL, P = 0.016]. In the larger cohort from which the participants were drawn, co-administration of fluconazole did not increase the risk of hepatotoxicity.

conclusionsFluconazole led to significant increases in nevirapine exposure, but was not associated with evidence of increased hepatotoxicity.

Indexed as

AdultAntifungal AgentsAnti-HIV AgentsCryptococcosisDrug InteractionsFemaleFluconazoleHIV InfectionsHumansMaleNevirapinePlacebosPlasmaUgandaAntifungal AgentsAnti-HIV AgentsFluconazoleNevirapinePlacebos

Identifiers

PMID20032007
PMCPMC2809247
OpenAlexW2169596203

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.