Evidence map›Paper›PMID 22430963›Full record

Trial reportAntimicrobial agents and chemotherapy2012

Effect of milk thistle on the pharmacokinetics of darunavir-ritonavir in HIV-infected patients.

José Moltó, Marta Valle, Cristina Miranda, Samandhy Cedeño, Eugenia Negredo, Bonaventura Clotet

Abstract readClinical Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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

12 citing papers in PubMed.

  1. Trial
  2. The effects of milk thistle (Silybum marianum) on human cytochrome P450 activity.Drug metabolism and disposition: the biological fate of chemicals · 2014
    Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. A Review of the Toxicity of HIV Medications II: Interactions with Drugs and Complementary and Alternative Medicine Products.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2015
    Review
  9. Herb-drug interactions: challenges and opportunities for improved predictions.Drug metabolism and disposition: the biological fate of chemicals · 2014
    Article
  10. Article
  11. Drug-drug interactions during antiviral therapy for chronic hepatitis C.Nature reviews. Gastroenterology & hepatology · 2013
    Review
  12. 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.

José MoltóLluita contra la Sida Foundation, HIV Clinic, Hospital Universitari Germans Trias i Pujol, Badalona, Spain. jmolto@flsida.org
Marta Valle
Cristina Miranda
Samandhy Cedeño
Eugenia Negredo
Bonaventura Clotet

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this open-label, fixed-sequence study was to investigate the potential of the botanical supplement milk thistle (silymarin) to interact with the boosted protease inhibitor combination darunavir-ritonavir. Fifteen HIV-infected patients receiving antiretroviral therapy with darunavir-ritonavir (600/100 mg twice daily) for at least 4 weeks were included. Silymarin (150 mg every 8 h) was added to the antiretroviral treatment from days 1 to 14. Darunavir concentrations in plasma were determined by high-performance liquid chromatography immediately before and 1, 2, 4, 6, 8, 10, and 12 h after a morning dose of darunavir-ritonavir on day 0 and darunavir-ritonavir plus silymarin on day 14. Individual darunavir pharmacokinetic parameters were calculated by noncompartmental analysis and compared between days 0 and 14 by means of the geometric mean ratio (GMR) and its 90% confidence interval (CI). The median age was 48 years (interquartile range, 44 to 50 years), and the median body weight was 70 kg (interquartile range, 65 to 84 kg). Silymarin was well tolerated, and all participants completed the study. The GMRs for darunavir coadministered with silymarin relative to darunavir alone were 0.86 (90% CI, 0.70 to 1.05) for the area under the concentration-time curve from 0 to 12 h, 0.83 (90% CI, 0.80 to 0.98) for the maximum concentration, and 0.94 (90% CI, 0.73 to 1.19) for the concentration at the end of the dosing interval. In summary, coadministration of silymarin with darunavir-ritonavir seems to be safe in HIV-infected patients; no dose adjustment for darunavir-ritonavir seems to be necessary.

Indexed as

AdultAnti-HIV AgentsDarunavirDrug Administration ScheduleHIV InfectionsHumansMaleMiddle AgedRitonavirSilybum marianumSilymarinSulfonamidesAnti-HIV AgentsDarunavirRitonavirSilymarinSulfonamides

Identifiers

PMID22430963
PMCPMC3370734

What OpenQuestion holds

Textmetadata
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.