Evidence map›Paper›PMID 20420510›Full record

Trial reportThe Journal of infectious diseases2010

Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial.

David M Asmuth, Robert L Murphy, Susan L Rosenkranz, Juan J L Lertora, Shyam Kottilil, Yoninah Cramer, Ellen S Chan, Robert T Schooley, Charles R Rinaldo, Nathan Thielman and 8 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed
4.5field-weighted citation impact, top 5% 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

85 citing papers in PubMed, 118 citations in OpenAlex.

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25 more citing papers are in PubMed but not listed here.

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

18 authors at 9 institutions in 1 country.

David M AsmuthDivision of Infectious Diseases, University of California-Davis Medical School, 4150 V Street, Sacramento, CA 95817-1460, USA. david.asmuth@ucdmc.ucdavis.edu
Robert L Murphy
Susan L Rosenkranz
Juan J L Lertora
Shyam Kottilil
Yoninah Cramer
Ellen S Chan
Robert T Schooley
Charles R Rinaldo
Nathan Thielman
Xiao-Dong Li
Sharon M Wahl
Jessica Shore
Jennifer Janik
Richard A Lempicki
Yaa Simpson
Richard B Pollard
AIDS Clinical Trials Group A5192 Team
Harvard University · USNational Institutes of Health Clinical Center · USNorthwestern University · USUniversity of California Davis Medical Center · USDuke University · USFrontier Science & Technology Research Foundation · USScience Applications International Corporation (United States) · USUniversity of California San Diego · USUniversity of Pittsburgh · US

Funding

AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
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
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitU01AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 2007 to 2011
$19.3M
HIV/AIDS Clinical Trials UnitU01AI069484 · NIAID · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2007 to 2011
$14.6M
Northwestern University Clinical Trial UnitU01AI069471 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MURPHY, ROBERT LEO · 2007 to 2011
$12.0M
Therapeutic Strategies for the Management of HCV/HIV co- infectionZIAAI000390 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI FAUCI, ANTHONY S. · 2009 to 2014
$4.2M
Role Of Monocytes In AIDS And As Targets For Antiviral TherapyZIADE000513 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI WAHL, SHARON M · 2009 to 2012
$2.9M
Intramural NIH HHSNIAID NIH HHS 1U01-AI068634NIAID NIH HHS 1U01-AI068636NIAID NIH HHS 1U01-AI069432NIAID NIH HHS 1U01-AI069471NIAID NIH HHS 1U01-AI069484NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069484
6 · The paper itself

Abstract

backgroundTo our knowledge, the antiviral activity of pegylated interferon alfa-2a has not been studied in participants with untreated human immunodeficiency virus type 1 (HIV-1) infection but without chronic hepatitis C virus (HCV) infection.

methodsUntreated HIV-1-infected volunteers without HCV infection received 180 microg of pegylated interferon alfa-2a weekly for 12 weeks. Changes in plasma HIV-1 RNA load, CD4(+) T cell counts, pharmacokinetics, pharmacodynamic measurements of 2',5'-oligoadenylate synthetase (OAS) activity, and induction levels of interferon-inducible genes (IFIGs) were measured. Nonparametric statistical analysis was performed.

resultsEleven participants completed 12 weeks of therapy. The median plasma viral load decrease and change in CD4(+) T cell counts at week 12 were 0.61 log(10) copies/mL (90% confidence interval [CI], 0.20-1.18 log(10) copies/mL) and -44 cells/microL (90% CI, -95 to 85 cells/microL), respectively. There was no correlation between plasma viral load decreases and concurrent pegylated interferon plasma concentrations. However, participants with larger increases in OAS level exhibited greater decreases in plasma viral load at weeks 1 and 2 (r = -0.75 [90% CI, -0.93 to -0.28] and r = -0.61 [90% CI, -0.87 to -0.09], respectively; estimated Spearman rank correlation). Participants with higher baseline IFIG levels had smaller week 12 decreases in plasma viral load (0.66 log(10) copies/mL [90% CI, 0.06-0.91 log(10) copies/mL]), whereas those with larger IFIG induction levels exhibited larger decreases in plasma viral load (-0.74 log(10) copies/mL [90% CI, -0.93 to -0.21 log(10) copies/mL]).

conclusionPegylated interferon alfa-2a was well tolerated and exhibited statistically significant anti-HIV-1 activity in HIV-1-monoinfected patients. The anti-HIV-1 effect correlated with OAS protein levels (weeks 1 and 2) and IFIG induction levels (week 12) but not with pegylated interferon concentrations.

Indexed as

2',5'-Oligoadenylate SynthetaseAdultAnti-HIV AgentsCD4 Lymphocyte CountGene Expression ProfilingHIV-1HIV InfectionsHumansInterferon-alphaInterferon alpha-2MaleMiddle AgedPolyethylene GlycolsRecombinant ProteinsRNA, ViralTreatment Outcome2',5'-Oligoadenylate SynthetaseAnti-HIV AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRNA, Viral

Identifiers

PMID20420510
PMCPMC2946345
OpenAlexW2157749483

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

None linked

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.