Evidence map›Paper›PMID 25664185›Full record

ArticleAIDS research and treatment2015

Pharmacokinetics of Etravirine Combined with Atazanavir/Ritonavir and a Nucleoside Reverse Transcriptase Inhibitor in Antiretroviral Treatment-Experienced, HIV-1-Infected Patients.

Catherine Orrell, Franco Felizarta, André Nell, Thomas N Kakuda, Ludo Lavreys, Steven Nijs, Lotke Tambuyzer, Rodica Van Solingen-Ristea, Frank L Tomaka

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in AIDS research and treatment, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00896051 (TMC125-TiDP2-C238), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 37% 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.

NCT00896051 phase2completednot on this map

TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment-experienced HIV-1 Infected Subjects

TypeinterventionalSponsorJanssen R&D IrelandRan2009 to 2012Enrolled50ConditionsHIV Infections, Acquired Immunodeficiency SyndromeArmsAtazanavir (ATV) 300 mg, Atazanavir (ATV) 400 mg, Ritonavir (rtv) 100 mg, Nucleo(side)/(tide) reverse transcriptase inhibitors (NRTIs), Etravirine (ETR) 200 mg
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. 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 5 institutions in 3 countries.

Catherine OrrellDesmond Tutu HIV Foundation, UCT Medical School, P.O. Box 13801, Mowbray, Cape Town 7705, South Africa.
Franco FelizartaPrivate Practice, 3535 San Dimas Street, Suite 24, Bakersfield, CA 93301, USA.
André NellParexel International, University of the Free State, Campus Avenue South, Bloemfontein, Free State 9301, South Africa.
Thomas N KakudaJanssen Research & Development LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560-0200, USA.
Ludo LavreysJanssen Infectious Diseases BVBA, Turnhoutseweg 30, 2340 Beerse, Belgium.
Steven NijsJanssen Infectious Diseases BVBA, Turnhoutseweg 30, 2340 Beerse, Belgium.
Lotke TambuyzerJanssen Infectious Diseases BVBA, Turnhoutseweg 30, 2340 Beerse, Belgium.
Rodica Van Solingen-RisteaJanssen Research & Development LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560-0200, USA.
Frank L TomakaJanssen Research & Development LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560-0200, USA.
Janssen (Belgium) · BEJanssen (United States) · USBakersfield College · USDesmond Tutu HIV Foundation · ZAUniversity of the Free State · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives. TEACH (NCT00896051) was a randomized, open-label, two-arm Phase II trial to investigate the pharmacokinetic interaction between etravirine and atazanavir/ritonavir and safety and efficacy in treatment-experienced, HIV-1-infected patients. Methods. After a two-week lead-in of two nucleoside reverse transcriptase inhibitors (NRTIs) and atazanavir/ritonavir 300/100 mg, 44 patients received etravirine 200 mg bid with one NRTI, plus atazanavir/ritonavir 300/100 mg or 400/100 mg qd (n = 22 each group) over 48 weeks. Results. At steady-state etravirine with atazanavir/ritonavir 300/100 mg qd or 400/100 mg qd decreased atazanavir C min⁡ by 18% and 9%, respectively, with no change in AUC24 h or C max⁡ versus atazanavir/ritonavir 300/100 mg qd alone (Day -1). Etravirine AUC12 h was 24% higher and 16% lower with atazanavir/ritonavir 300/100 or 400/100 mg qd, respectively, versus historical controls. At Week 48, no significant differences were seen between the atazanavir/ritonavir groups in discontinuations due to adverse events (9.1% each group) and other safety parameters, the proportion of patients with viral load <50 copies/mL (intent-to-treat population, noncompleter = failure) (50.0%, atazanavir/ritonavir 300/100 mg qd versus 45.5%, 400/100 mg qd), and virologic failures (31.8% versus 27.3%, resp.). Conclusions. Etravirine 200 mg bid can be combined with atazanavir/ritonavir 300/100 mg qd and an NRTI in HIV-1-infected, treatment-experienced patients without dose adjustment.

Identifiers

PMID25664185
PMCPMC4312629
OpenAlexW2035974951

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Registered trials

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.