Evidence map›Paper›PMID 24334180›Full record

Trial reportHIV clinical trials

Addition of nitazoxanide to PEG-IFN and ribavirin to improve HCV treatment response in HIV-1 and HCV genotype 1 coinfected persons naïve to HCV therapy: results of the ACTG A5269 trial.

Valerianna K Amorosa, Anne Luetkemeyer, Minhee Kang, Victoria A Johnson, Triin Umbleja, David W Haas, Suria Yesmin, Matthew C Bardin, Ray T Chung, Beverly Alston-Smith and 2 more

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in HIV clinical trials. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. 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

12 authors at 8 institutions in 1 country.

Valerianna K AmorosaPhiladelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Anne LuetkemeyerUniversity of California at San Francisco, San Francisco, California.
Minhee KangHarvard School of Public Health, Boston, Massachusetts.
Victoria A JohnsonBirmingham Veterans Affairs Medical Center, Birmingham, Alabama University of Alabama School of Medicine, Birmingham, Alabama.
Triin UmblejaHarvard School of Public Health, Boston, Massachusetts.
David W HaasVanderbilt School of Medicine, Nashville, Tennessee.
Suria YesminACTG Operations Center, Silver Spring, Maryland.
Matthew C BardinRomark Laboratories LC, Tampa, Florida.
Ray T ChungHarvard Medical School, Boston, Massachsetts.
Beverly Alston-SmithDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Pablo TebasUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Marion G PetersUniversity of California at San Francisco, San Francisco, California.
Harvard University · USUniversity of California, San Francisco · USUniversity of Pennsylvania · USAIDS Clinical Trials Group · USBirmingham VA Medical Center · USNational Institute of Allergy and Infectious Diseases · USRomark (United States) · USVanderbilt Health · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virology CoreP30AI027767 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI OLAF KUTSCH · 1988 to 2026
$84.1M
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
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
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
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024996 · NCRR · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2007 to 2011
$49.6M
NCATS NIH HHS UL1 TR000058NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1-TR00058NCRR NIH HHS 5 UL1 RR021456-07NCRR NIH HHS RR024996NCRR NIH HHS RR 025747NCRR NIH HHS UL1 RR 024160NCRR NIH HHS UL1 RR024160NCRR NIH HHS UL1 RR024989NCRR NIH HHS UL1RR024989NCRR NIH HHS UL1 RR024996NCRR NIH HHS UL1 RR025747NIAAA NIH HHS R01 AA012879NIAID NIH HHS 1U01AI068634NIAID NIH HHS 1U01AI068636NIAID NIH HHS 1U01AI069472NIAID NIH HHS 1-UO1-AI069503NIAID NIH HHS 5U01 AI069470-01NIAID NIH HHS 5UM1 AI069415-06NIAID NIH HHS 5UM1 AI06953-07NIAID NIH HHS 5UO1 AI069502-06NIAID NIH HHS 7UM1AI068636NIAID NIH HHS AI050410NIAID NIH HHS AI069419NIAID NIH HHS AI069423NIAID NIH HHS AI 069424NIAID NIH HHS AI069501NIAID NIH HHS AI069556NIAID NIH HHS AI69432NIAID NIH HHS P30 AI027767NIAID NIH HHS P30 AI050410NIAID NIH HHS P30AI27767-24NIAID NIH HHS R21 AI069053NIAID NIH HHS U01 AI027663NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069470NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069502NIAID NIH HHS U01 AI069503NIAID NIH HHS U01 AI069511NIAID NIH HHS U01AI069511-02NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069556NIAID NIH HHS U01-AI-096497NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069513NIAID NIH HHS UM1 AI069534NIAID NIH HHS UM1 AI069556NIDDK NIH HHS P30 DK026743PHS HHS U01- A1069472
6 · The paper itself

Abstract

backgroundWe hypothesized that nitazoxanide (NTZ) added to pegylated interferon alfa-2a (PEG-IFN) and weight-based ribavirin (WBR) would improve hepatitis C virus (HCV) virologic responses in HCV treatment-naïve HIV-1/HCV genotype 1 coinfected persons.

methodsProspective, single-arm study in which subjects received 4-week lead-in (NTZ 500 mg twice daily) followed by 48 weeks of NTZ, PEG-IFN, and WBR. We compared the HCV virologic responses of these subjects to historical controls from the completed ACTG study A5178 who received PEG-IFN and WBR and had similar subject characteristics. Primary endpoints were early virologic response and complete early virologic response (EVR and cEVR).

resultsAmong 67 subjects (78% male; 48% Black; median age, 50 years), EVR was achieved in 65.7% (90% CI, 55.0%-75.3%), cEVR in 38.8% (28.8%-49.6%). and SVR in 32.8% (23.4%-43.5%). EVR was higher with NTZ (51.4% in A5178; P = .03), but the sustained virologic response (SVR) proportion was similar (27.3% in A5178; P = .24). In contrast to A5178, SVR was similar across IL28B genotypes. Overall, NTZ was safe and well-tolerated.

conclusionWhereas EVR proportion improved significantly in this pilot study, the addition of NTZ to PEG-IFN/WBR did not significantly improve SVR compared to historical controls. NTZ may be associated with an attenuation of the effect of IL28B on HCV treatment response.

Indexed as

HIV-1AdultAnimalsAntiviral AgentsDrug Therapy, CombinationFemaleHepacivirusHepatitis CHIV InfectionsHumansInterferon-alphaMaleMiddle AgedNitro CompoundsPilot ProjectsPolyethylene GlycolsAntiviral AgentsInterferon-alphanitazoxanideNitro Compoundspeginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinThiazolesgenotype 1hepatitis CHIVnitazoxanidepegylated interferonribavirin

Identifiers

PMID24334180
PMCPMC4113390
OpenAlexW2164302720

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Registered trials

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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.