Evidence map›Paper›PMID 26636929›Full record

Trial reportAIDS (London, England)2016

A 48-week randomized phase 2b study evaluating cenicriviroc versus efavirenz in treatment-naive HIV-infected adults with C-C chemokine receptor type 5-tropic virus.

Melanie Thompson, Michael Saag, Edwin DeJesus, Joseph Gathe, Jay Lalezari, Alan L Landay, Jerry Cade, Jeffrey Enejosa, Eric Lefebvre, Judith Feinberg

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01338883 (A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc), which is not on this map. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
4.8field-weighted citation impact, top 4% 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.

NCT01338883 phase2completednot on this map

A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR 652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV 1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus

TypeinterventionalSponsorTobira Therapeutics, Inc.Ran2011 to 2013Enrolled143ConditionsHIV-1 InfectionArmsCenicriviroc 100 mg, Cenicriviroc 200 mg + Truvada, Sustiva + Truvada
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 87 citations in OpenAlex.

  1. Trial
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  3. Improvement in Hepatic Fibrosis Biomarkers Associated With Chemokine Receptor Inactivation Through Mutation or Therapeutic Blockade.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
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  7. Article
  8. Immunity in Rodent Models of Stress.Biological psychiatry · 2026
    Review
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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

10 authors at 1 institution in 1 country.

Melanie ThompsonaAIDS Research Consortium of Atlanta, Atlanta, Georgia bUniversity of Alabama at Birmingham, Birmingham, Alabama cOrlando Immunology Center, Orlando, Florida dTherapeutic Concepts, Houston, Texas eQuest Clinical Research, San Francisco, California fRush University, Chicago, Illinois gNevada AIDS Research and Education Society, Las Vegas, Nevada hTobira Therapeutics, Inc., South San Francisco, California iUniversity of Cincinnati, Cincinnati, Ohio, USA.
Michael Saag
Edwin DeJesus
Joseph Gathe
Jay Lalezari
Alan L Landay
Jerry Cade
Jeffrey Enejosa
Eric Lefebvre
Judith Feinberg
AIDS Research Consortium of Atlanta · US

Funding

West Virginia IDEA-CTRU54GM104942 · NIGMS · WEST VIRGINIA UNIVERSITY · PI Sally Lynn Hodder · 2012 to 2026
$81.0M
NIGMS NIH HHS U54 GM104942
6 · The paper itself

Abstract

objectiveTo compare the efficacy, safety, and anti-inflammatory effects of cenicriviroc (CVC), an oral, once-daily C-C chemokine receptor types 5 and 2 antagonist, with those of efavirenz (EFV) in treatment-naive, HIV-1-infected adults.

designA 48-week, randomized, double-blind, double-dummy phase 2b trial at 43 institutions (USA and Puerto Rico).

methodsStudy participants (HIV-1 RNA ≥1000 copies/ml, CD4 cell count ≥200 cells/μl, C-C chemokine receptor type 5-tropic virus) were randomized 2 : 2 : 1 to CVC 100 mg (CVC100), CVC 200 mg (CVC200), or EFV 600 mg, each administered with emtricitabine/tenofovir disoproxil fumarate. Key end points were virologic success (HIV-1 RNA <50 copies/ml) at week 24 (primary) and week 48 (secondary), safety/tolerability at weeks 24 and 48. Study sites and patients remained blinded until week 48.

resultsA total of 143 patients were randomized (CVC100, n = 59; CVC200, n = 56; EFV, n = 28). Virologic success was obtained at week 24 in 76, 73, and 71% of study participants for CVC100, CVC200, and EFV, respectively (all P > 0.05 versus EFV), and at week 48 in 68, 64, and 50%, respectively (all P > 0.05 versus EFV). Resistance mutations emerged in five and zero CVC and EFV-treated study participants, respectively. Virologic nonresponse and nucleoside reverse transcriptase inhibitor resistance decreased when CVC minimum plasma concentration was at least 47.8 ng/ml. Treatment-related adverse events of at least grade 2 and discontinuations because of adverse events were less frequent in CVC-treated study participants. Total and low-density lipoprotein cholesterol decreased with CVC, but increased with EFV. C-C chemokine ligand type 2 (CCL2) (aka monocyte chemotactic protein-1) increased in a dose-dependent manner, whereas soluble CD14 levels decreased with CVC.

conclusionCVC showed efficacy and favorable safety in treatment-naive HIV-1-infected study participants, supporting selection of CVC200 for phase 3 studies.

trial registrationNCT01338883.

Indexed as

Viral TropismAdultAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDouble-Blind MethodFemaleGenotypeHIV-1HIV InfectionsHumansImidazolesImmunologic FactorsMaleMiddle AgedAlkynesAnti-HIV AgentsBenzoxazinescenicrivirocCXCR5 protein, humanCyclopropanesefavirenzImidazolesImmunologic FactorsReceptors, CXCR5Receptors, HIVSulfoxides

Identifiers

PMID26636929
PMCPMC4794136
OpenAlexW2413287636

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.