Evidence map›Paper›PMID 34676683›Full record

ArticleClinical pharmacology in drug development2021

Lack of a Clinically Meaningful Drug Interaction Between the HIV-1 Antiretroviral Agents Islatravir, Dolutegravir, and Tenofovir Disoproxil Fumarate.

Deanne Jackson Rudd, Saijuan Zhang, Kerry L Fillgrove, Sabrina Fox-Bosetti, Randolph P Matthews, Evan Friedman, Danielle Armas, S Aubrey Stoch, Marian Iwamoto

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical pharmacology in drug development, 2021. 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 33% 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, 8 citations in OpenAlex.

  1. Article
  2. Article
  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

9 authors at 2 institutions in 1 country.

Deanne Jackson RuddMerck & Co., Inc., Kenilworth, New Jersey, USA.
Saijuan ZhangMerck & Co., Inc., Kenilworth, New Jersey, USA.
Kerry L FillgroveMerck & Co., Inc., Kenilworth, New Jersey, USA.
Sabrina Fox-BosettiMerck & Co., Inc., Kenilworth, New Jersey, USA.
Randolph P MatthewsMerck & Co., Inc., Kenilworth, New Jersey, USA.
Evan FriedmanMerck & Co., Inc., Kenilworth, New Jersey, USA.
Danielle ArmasCelerion, Tempe, Arizona, USA.
S Aubrey StochMerck & Co., Inc., Kenilworth, New Jersey, USA.
Marian IwamotoMerck & Co., Inc., Kenilworth, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCelerion (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, is in clinical development for the treatment and prevention of HIV-1 infection. Because islatravir may be coadministered with other antiretroviral agents, assessment of potential drug-drug interactions are warranted. This phase 1, open-label, fixed-sequence, 2-period trial in adults without HIV (N = 12) assessed the safety and pharmacokinetic interactions of islatravir administered with dolutegravir and tenofovir disoproxil fumarate (TDF). In period 1, participants received a single oral dose of islatravir (20 mg). In period 2, participants received oral doses of dolutegravir (50 mg) and TDF (300 mg) once daily on days 1 through 11, with a single oral dose of islatravir (20 mg) coadministered on day 8. There were no clinically significant changes in islatravir, dolutegravir, or TDF pharmacokinetics following coadministration. Islatravir was generally well tolerated when administered alone or in combination with dolutegravir and TDF. Coadministration of islatravir, dolutegravir, and TDF is supported, with no clinically meaningful effect on pharmacokinetics, safety, or tolerability in participants without HIV.

Indexed as

HIV-1AdultAnti-Retroviral AgentsDeoxyadenosinesDolutegravirDrug InteractionsHeterocyclic Compounds, 3-RingHumansOxazinesPiperazinesPyridonesTenofovirAnti-Retroviral AgentsDeoxyadenosinesDolutegravirHeterocyclic Compounds, 3-RingislatravirOxazinesPiperazinesPyridonesTenofovirclinical pharmacologyclinical trialsdrug-drug interactionsHIV/AIDSpharmacokinetics and drug metabolism

Identifiers

PMID34676683
PMCPMC9298070
OpenAlexW3206219753

What OpenQuestion holds

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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.