Evidence map›Paper›PMID 34427938›Full record

ArticleBritish journal of clinical pharmacology2022

Lack of pharmacokinetic interaction between the HIV-1 maturation inhibitor GSK3640254 and combination oral contraceptives in healthy women.

Teodora Pene Dumitrescu, Thomas J Greene, Samit R Joshi, Jianfeng Xu, Mark Johnson, Fiona Halliday, Laurie Butcher, Eric Zimmerman, Lindsey Webster, Theresa T Pham and 2 more

Open access · hybridAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. 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

12 authors at 5 institutions in 3 countries.

Teodora Pene DumitrescuGlaxoSmithKline, Collegeville, PA, USA.
Thomas J GreeneGlaxoSmithKline, Collegeville, PA, USA.
Samit R JoshiViiV Healthcare, Branford, CT, USA.
Jianfeng XuGlaxoSmithKline, Collegeville, PA, USA.
Mark JohnsonViiV Healthcare, Research Triangle Park, NC, USA.
Fiona HallidayGlaxoSmithKline, Uxbridge, UK.
Laurie ButcherGlaxoSmithKline, Collegeville, PA, USA.
Eric ZimmermanPPD, Richmond, VA, USA.
Lindsey WebsterPPD, Richmond, VA, USA.
Theresa T PhamPPD, Austin, TX, USA.
Max LatailladeViiV Healthcare, Branford, CT, USA.
Sherene MinViiV Healthcare, Research Triangle Park, NC, USA.
GlaxoSmithKline (United States) · USPharmaceutical Product Development (United States) · USTriangle · USViiV Healthcare (Spain) · ESGlaxoSmithKline (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsGSK3640254 is a next-generation maturation inhibitor likely to be coadministered with combined oral contraceptives in HIV-positive women.

methodsThis phase I, open-label, 1-way study assessed pharmacokinetic and pharmacodynamic interactions of GSK3640254 200 mg and ethinyl oestradiol 0.03 mg/levonorgestrel 0.15 mg once daily in healthy female participants who received ethinyl oestradiol/levonorgestrel for 10 days with a moderate-fat meal after which GSK3640254 was added from Days 11 to 21. Primary endpoints were area under the plasma concentration-time curve to the end of the dosing interval (AUC

resultsAmong 23 enrolled participants, 17 completed the study. Geometric least squares mean ratios (with vs. without GSK3640254) of AUC

conclusionEthinyl oestradiol/levonorgestrel plus GSK3640254 coadministration did not affect steady-state pharmacokinetics or pharmacodynamics of ethinyl oestradiol and levonorgestrel in healthy female participants. No major tolerability findings were reported. Elevated liver transaminase levels were probably due to ethinyl oestradiol/levonorgestrel.

Indexed as

HIV-1LevonorgestrelContraceptives, Oral, CombinedDrug InteractionsEthinyl EstradiolFemaleFollicle Stimulating HormoneHumansLuteinizing HormoneProgesteroneTransaminasesContraceptives, Oral, CombinedEthinyl EstradiolFollicle Stimulating HormoneLevonorgestrelLuteinizing HormoneProgesteroneTransaminasesdrug-drug interactionethinyl oestradiolHIV infectionlevonorgestrelpharmacodynamics

Identifiers

PMID34427938
PMCPMC9291532
OpenAlexW3196205577

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.