Evidence map›Paper›PMID 20672447›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2010

Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients.

Timothy J Wilkin, Zhaohui Su, Amy Krambrink, Jianmin Long, Wayne Greaves, Robert Gross, Michael D Hughes, Charles Flexner, Paul R Skolnik, Eoin Coakley and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00686829 (Vicriviroc), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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.

NCT00686829 phase2completednot on this map

Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2005 to 2010Enrolled79ConditionsHIV, HIV InfectionsArmsVicriviroc maleate
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Phase 1 Pharmacokinetic Trial of 2 Intravaginal Rings Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Trial
  3. Trial
  4. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients.Journal of acquired immune deficiency syndromes (1999) · 2014
    Trial
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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

14 authors.

Timothy J WilkinDivision of Infectious Diseases Weill Cornell Medical College, New York, NY, USA. tiw2001@med.cornell.edu
Zhaohui Su
Amy Krambrink
Jianmin Long
Wayne Greaves
Robert Gross
Michael D Hughes
Charles Flexner
Paul R Skolnik
Eoin Coakley
Catherine Godfrey
Martin Hirsch
Daniel R Kuritzkes
Roy M Gulick

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024996 · NCRR · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2007 to 2011
$49.6M
Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Colleen F Kelley · 2012 to 2026
$46.0M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 2012 to 2026
$44.6M
NCRR NIH HHS M01 RR000046NCRR NIH HHS M01 RR000052NCRR NIH HHS M01 RR000096NCRR NIH HHS M01-RR00046NCRR NIH HHS M01-RR00052NCRR NIH HHS M01-RR00096NCRR NIH HHS M01 RR005280NCRR NIH HHS M01-RR024160NCRR NIH HHS M01- RR025780NCRR NIH HHS RR024979NCRR NIH HHS UL1 RR024160NCRR NIH HHS UL1 RR024979NCRR NIH HHS UL1 RR024996NCRR NIH HHS UL1-RR024996NCRR NIH HHS UL1 RR025780NIAID NIH HHS AI-25859NIAID NIH HHS AI-27661NIAID NIH HHS AI-32782NIAID NIH HHS AI-34853NIAID NIH HHS AI-46370NIAID NIH HHS AI-68634NIAID NIH HHS AI-69418NIAID NIH HHS AI-69419NIAID NIH HHS AI-69423NIAID NIH HHS AI-69424NIAID NIH HHS AI-69432NIAID NIH HHS AI-69434NIAID NIH HHS AI-69439NIAID NIH HHS AI-69450NIAID NIH HHS AI-69465NIAID NIH HHS AI-69467NIAID NIH HHS AI-69471NIAID NIH HHS AI-69472NIAID NIH HHS AI-69474NIAID NIH HHS AI-69494NIAID NIH HHS AI-69495NIAID NIH HHS AI-69501NIAID NIH HHS AI-69502NIAID NIH HHS AI- 69511NIAID NIH HHS AI-69532NIAID NIH HHS AI-69556NIAID NIH HHS K23 AI055038NIAID NIH HHS K23-AI-55038NIAID NIH HHS K24 AI051966NIAID NIH HHS K24-AI-51966NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI050410NIAID NIH HHS P30-AI-45008NIAID NIH HHS P30-AI-50410NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI027661NIAID NIH HHS U01 AI032782NIAID NIH HHS U01 AI034853NIAID NIH HHS U01 AI046370NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069418NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069434NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069465NIAID NIH HHS U01 AI069467NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069494NIAID NIH HHS U01 AI069495NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069502NIAID NIH HHS U01 AI069511NIAID NIH HHS U01 AI069532NIAID NIH HHS U01 AI069556NIAID NIH HHS U01-AI-68636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069434NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069467NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069495NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069502NIAID NIH HHS UM1 AI069532NIAID NIH HHS UM1 AI069556
6 · The paper itself

Abstract

backgroundVicriviroc, an investigational CCR5 antagonist, demonstrated short-term safety and antiretroviral activity.

methodsPhase 2, double-blind, randomized study of vicriviroc in treatment-experienced subjects with CCR5-using HIV-1. Vicriviroc (5, 10, or 15 mg) or placebo was added to a failing regimen with optimization of background antiretroviral medications at day 14. Subjects experiencing virologic failure and subjects completing 48 weeks were offered open-label vicriviroc.

resultsOne hundred eighteen subjects were randomized. Virologic failure (<1 log10 decline in HIV-1 RNA > or =16 weeks postrandomization) occurred by week 48 in 24 of 28 (86%), 12 of 30 (40%), 8 of 30 (27%), 10 of 30 (33%) of subjects randomized to placebo, 5, 10, and 15 mg, respectively. Overall, 113 subjects received vicriviroc at randomization or after virologic failure, and 52 (46%) achieved HIV-1 RNA <50 copies per milliliter within 24 weeks. Through 3 years, 49% of those achieving suppression did not experience confirmed viral rebound. Dual or mixed-tropic HIV-1 was detected in 33 (29%). Vicriviroc resistance (progressive decrease in maximal percentage inhibition on phenotypic testing) was detected in 6 subjects. Nine subjects discontinued vicriviroc due to adverse events.

conclusionsVicriviroc seems safe and demonstrates sustained virologic suppression through 3 years of follow-up. Further trials of vicriviroc will establish its clinical utility for the treatment of HIV-1 infection.

Indexed as

AdultAnti-HIV AgentsFemaleHIV-1HIV InfectionsHumansMaleMiddle AgedPiperazinesPlacebosPyrimidinesTreatment OutcomeViral LoadAnti-HIV AgentsPiperazinesPlacebosPyrimidinesvicriviroc

Identifiers

PMID20672447
PMCPMC2917795

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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.