Evidence map›Paper›PMID 20921898›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2010

Sustained long-term antiviral maintenance therapy in HCV/HIV-coinfected patients (SLAM-C).

Kenneth E Sherman, Janet W Andersen, Adeel A Butt, Triin Umbleja, Beverly Alston, Margaret J Koziel, Marion G Peters, Mark Sulkowski, Zachary D Goodman, Raymond T Chung and 1 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized 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 NCT00078403 (Suppressive Long-Term Antiviral Management of Hepatitis C Virus), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.0field-weighted citation impact, top 9% 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.

NCT00078403 phase2completednot on this map

Suppressive Long-Term Antiviral Management of Hepatitis C Virus (HCV) and HIV-1 Coinfected Subjects (SLAM-C)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2009Enrolled333ConditionsHIV Infections, Hepatitis C, Liver DiseaseArmsPeginterferon alfa-2a, Ribavirin
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Hepatitis C Virus and HIV Type 1 Co-Infection.Infectious disease reports · 2013
    Review
  10. Chronic liver disease in the Hispanic population of the United States.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2011
    Review
  11. 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

11 authors at 7 institutions in 1 country.

Kenneth E ShermanDepartment of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA. kenneth.sherman@uc.edu
Janet W Andersen
Adeel A Butt
Triin Umbleja
Beverly Alston
Margaret J Koziel
Marion G Peters
Mark Sulkowski
Zachary D Goodman
Raymond T Chung
AIDS Clinical Trials Group A5178 Study Team
Harvard University Press · USUniversity of Cincinnati · USArmed Forces Institute of Pathology · USMassachusetts General Hospital · USNational Institutes of Health · USUniversity of California, San Francisco · USUniversity of Pittsburgh · US

Funding

WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
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
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
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
ZDV &3TC NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFECTED INFANTS &M01RR000865 · NCRR · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI WASHINGTON, ARNOLD E. · 1985 to 2011
$43.4M
Zonisamide in Patients with Neuropathic Pain Associated with Diabetic NeuropathyM01RR000046 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI JOY, MELANIE S · 1985 to 2008
$38.5M
Intramural NIH HHS Z01 AI000695NCRR NIH HHS 5-MO1 RR00044NCRR NIH HHS 5-MO1RR00044NCRR NIH HHS M01 RR000032NCRR NIH HHS M01 RR000044NCRR NIH HHS M01 RR000046NCRR NIH HHS M01 RR000096NCRR NIH HHS M01RR-00032NCRR NIH HHS M01 RR000865NCRR NIH HHS M01RR00096NCRR NIH HHS M01-RR00865NCRR NIH HHS P20 RR011126NCRR NIH HHS P20 RR 11126NCRR NIH HHS RR000046-48NCRR NIH HHS RR025780NCRR NIH HHS U54-RR023561NCRR NIH HHS UL1 RR024996NCRR NIH HHS UL1 RR025780NIAID NIH HHS 3-UO1AI046376-05S4NIAID NIH HHS 5U01AI069494NIAID NIH HHS 5UO1AI069502-03NIAID NIH HHS AI050410NIAID NIH HHS AI069423-03NIAID NIH HHS AI069428NIAID NIH HHS AI069439NIAID NIH HHS AI069452NIAID NIH HHS AI069471NIAID NIH HHS AI069513NIAID NIH HHS AI069532NIAID NIH HHS AI069556NIAID NIH HHS AI25859NIAID NIH HHS AI27661NIAID NIH HHS AI27665NIAID NIH HHS AI34853NIAID NIH HHS AI46370NIAID NIH HHS AI54907NIAID NIH HHS AI-69419NIAID NIH HHS AI69432NIAID NIH HHS AI69450NIAID NIH HHS AI69465NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI054907NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI027661NIAID NIH HHS U01 AI027665NIAID NIH HHS U01 AI034853NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI046370NIAID NIH HHS U01 AI046376NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069415NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069428NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069465NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069472NIAID NIH HHS U01AI069472-03NIAID NIH HHS U01 AI069494NIAID NIH HHS U01AI069494NIAID NIH HHS U01AI06949S-02NIAID NIH HHS U01AI0695NIAID NIH HHS U01 AI069502NIAID NIH HHS U01 AI069511NIAID NIH HHS U01AI069511-02NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069532NIAID NIH HHS U01 AI069556NIAID NIH HHS U01 AI38858NIAID NIH HHS U0I AI069415-03NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069428NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069513NIAID NIH HHS UM1 AI069532NIAID NIH HHS UM1 AI069556NIAID NIH HHS UOI AI 069472NIDA NIH HHS K24 DA034621NIDA NIH HHS R01 DA016065NIDDK NIH HHS K24 DK070528NIDDK NIH HHS K24 DK078772PHS HHS A1069472PHS HHS IUO1A1069472PHS HHS U01A106942
6 · The paper itself

Abstract

backgroundHepatitis C virus (HCV)/HIV coinfection treatment is suboptimal with low sustained viral response rates to standard therapies. A multicenter randomized clinical trial designed to assess the efficacy/safety of pegylated interferon maintenance therapy was performed by the National Institutes of Health-funded AIDS Clinical Trials Group network.

methodsHCV treatment-naive and nonresponding interferon-experienced subjects with confirmed HCV and HIV, CD4 >200 cells per cubic millimeter, and at least stage 1 fibrosis were enrolled and treated for 12 weeks with pegylated interferon alfa 2a 180 mcg per week (PEG) + weight-based ribavirin to determine response status. Nonresponder subjects (failure to clear HCV RNA or achieve 2-log drop) underwent liver biopsy and were randomized to receive full dose PEG or observation only for 72 weeks. Paired biopsies were evaluated by a central pathologist.

resultsThree hundred thirty subjects were enrolled; median age was 48 years; 43% white, 37% black, non-Hispanic; 83% male; CD4+ 498 cells per cubic millimeter; 32% were interferon experienced; 74% had entry HIV RNA <50 copies per milliliter. early virologic responder was observed in 55.9% and 42.5% achieved complete Early Viral Response (cEVR). A planned interim analysis of occurred when 84 subjects were randomized. With data on 40 paired biopsies available, a safety monitoring board stopped the trial due to lack of fibrosis progression (median = 0 Metavir units/year) in the observation arm.

conclusionsLack of fibrotic progression in the control arm was unexpected and may represent a short-term PEG/ribavirin therapy effect, high levels of HIV viral suppression, and use of antiretroviral regimens that may be less toxic than prior generations of therapy.

Indexed as

AdultAntiviral AgentsCD4 Lymphocyte CountDrug Therapy, CombinationFemaleHepacivirusHepatitis CHIV-1HIV InfectionsHumansInterferon-alphaLiverLiver CirrhosisMaleMiddle AgedPolyethylene GlycolsAntiviral AgentsInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinRNA, Viral

Identifiers

PMID20921898
PMCPMC3017670
OpenAlexW1975357921

What OpenQuestion holds

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Read underepoch 390

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.