Evidence map›Paper›PMID 21941167›Full record

Trial reportAIDS (London, England)2011

Initial viral decay to assess the relative antiretroviral potency of protease inhibitor-sparing, nonnucleoside reverse transcriptase inhibitor-sparing, and nucleoside reverse transcriptase inhibitor-sparing regimens for first-line therapy of HIV infection.

Richard H Haubrich, Sharon A Riddler, Heather Ribaudo, Gregory Direnzo, Karin L Klingman, Kevin W Garren, David L Butcher, James F Rooney, Diane V Havlir, John W Mellors and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 25% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Antiretroviral Therapy Reduces T-cell Activation and Immune Exhaustion Markers in Human Immunodeficiency Virus Controllers.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
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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

11 authors at 4 institutions in 3 countries.

Richard H HaubrichAntiviral Research Center, University of California San Diego, San Diego, California 92103, USA. rhaubrich@ucsd.edu
Sharon A Riddler
Heather Ribaudo
Gregory Direnzo
Karin L Klingman
Kevin W Garren
David L Butcher
James F Rooney
Diane V Havlir
John W Mellors
AIDS Clinical Trials Group (ACTG) A5160 and A5142 Study Teams
Apple (Israel) · ILAbbott Fund · USHarvard University · USUniversity at Albany, State University of New York · 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
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
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
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
VirologyP30AI036214 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Maile Ann Young Karris · 1994 to 2026
$78.4M
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 RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
NCATS NIH HHS UL1 TR000454NCRR NIH HHS M01 RR000032NCRR NIH HHS M01 RR000039NCRR NIH HHS M01 RR000044NCRR NIH HHS M01 RR000046NCRR NIH HHS M01 RR000047NCRR NIH HHS M01 RR000051NCRR NIH HHS M01 RR000052NCRR NIH HHS M01 RR000096NCRR NIH HHS M01 RR002635NCRR NIH HHS RR 00032NCRR NIH HHS RR 00039NCRR NIH HHS RR 00044NCRR NIH HHS RR 00046NCRR NIH HHS RR 00047NCRR NIH HHS RR 00051NCRR NIH HHS RR 00052NCRR NIH HHS RR 00075NCRR NIH HHS RR 00096NCRR NIH HHS RR 02635NCRR NIH HHS UL1 RR025008NIAID NIH HHS AI 060354NIAID NIH HHS AI 064086NIAID NIH HHS AI 068634NIAID NIH HHS AI 069411NIAID NIH HHS AI 069418NIAID NIH HHS AI 069419NIAID NIH HHS AI 069423NIAID NIH HHS AI 069424NIAID NIH HHS AI 069432NIAID NIH HHS AI 069434NIAID NIH HHS AI 069439NIAID NIH HHS AI 069447NIAID NIH HHS AI 069450NIAID NIH HHS AI 069452NIAID NIH HHS AI 069465NIAID NIH HHS AI 069470NIAID NIH HHS AI 069471NIAID NIH HHS AI 069472NIAID NIH HHS AI 069474NIAID NIH HHS AI 069477NIAID NIH HHS AI 069484NIAID NIH HHS AI 069494NIAID NIH HHS AI 069495NIAID NIH HHS AI 069501NIAID NIH HHS AI 069502NIAID NIH HHS AI06951NIAID NIH HHS AI 069532NIAID NIH HHS AI 069556NIAID NIH HHS AI 25859NIAID NIH HHS AI 27661NIAID NIH HHS AI 27673NIAID NIH HHS AI 32782NIAID NIH HHS AI 32783NIAID NIH HHS AI 34853NIAID NIH HHS AI 36214NIAID NIH HHS AI 38858NIAID NIH HHS AI 45008NIAID NIH HHS AI 46370NIAID NIH HHS AI 46376NIAID NIH HHS AI 46381NIAID NIH HHS AI 50410NIAID NIH HHS K24 AI051982NIAID NIH HHS K24 AI064086NIAID NIH HHS P30 AI027763NIAID NIH HHS P30 AI036214NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI050410NIAID NIH HHS P30 AI060354NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI027661NIAID NIH HHS U01 AI027673NIAID NIH HHS U01 AI032782NIAID NIH HHS U01 AI032783NIAID NIH HHS U01 AI034853NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI046370NIAID NIH HHS U01 AI046376NIAID NIH HHS U01 AI046381NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069411NIAID 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 AI069447NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069465NIAID NIH HHS U01 AI069470NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069477NIAID NIH HHS U01 AI069484NIAID NIH HHS U01 AI069494NIAID NIH HHS U01 AI069495NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069502NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069532NIAID NIH HHS U01 AI069556NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069411NIAID 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 AI069447NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069477NIAID NIH HHS UM1 AI069484NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI069495NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069502NIAID NIH HHS UM1 AI069513NIAID NIH HHS UM1 AI069532NIAID NIH HHS UM1 AI069556NIDA NIH HHS DA 12121
6 · The paper itself

Abstract

objectivesTo evaluate the effects of sex and initial antiretroviral regimen on decay of HIV-RNA and virologic outcome.

methodsWe conducted a viral dynamics substudy of A5142, a trial comparing lopinavir (LPV)/ritonavir with efavirenz (LPV/EFV) versus LPV and two nucleoside reverse transcriptase inhibitor (NRTI) (LPV) versus EFV and two NRTI (EFV) in antiretroviral (ARV)-naive individuals. HIV-RNA was measured at days 2, 10, and 14 in the substudy and at weeks 1, 4, and 8 in A5142 participants. Two-phase viral decay was estimated in the substudy with biexponential mixed-effects modeling and compared using Wilcoxon tests. Week 1 HIV-RNA change was assessed as a predictor of virologic failure (HIV-RNA above 50 or 200  copies/ml) at weeks 24-96 using logistic regression.

resultsSixty-eight individuals were enrolled in the substudy (median HIV-RNA 4.9 log(10)  copies/ml). Median rates of phase 1 viral decay by treatment were 0.61(EFV/LPV), 0.53(LPV), and 0.63(EFV) per day. Phase 1 decay was significantly faster for EFV than LPV (P = 0.023); other comparisons were not significant (P > 0.11). Viral decay did not differ by sex (P = 0.10). Week 1 HIV-RNA change, calculated in 571 participants of A5142, was greater for the EFV (median -1.47 log(10)  copies/ml) than either the LPV/EFV or LPV groups (-1.21 and -1.16 log(10 ) copies/ml, respectively; P < 0.001). Week 1 HIV-RNA change was associated with virologic failure above 50  copies/ ml at weeks 24 and 48 (P < 0.018), but not above 200  copies/ml at these time points or for any value at week 96.

conclusionPhase 1 decay was faster for EFV than LPV or LPV/EFV. Week 1 HIV-RNA change predicted virologic outcome up to week 48, but not at week 96.

Indexed as

AdultAlkynesBenzoxazinesCyclopropanesDrug Therapy, CombinationFemaleFollow-Up StudiesHIV-1HIV InfectionsHIV Protease InhibitorsHumansLopinavirMaleMiddle AgedReverse Transcriptase InhibitorsRitonavirAlkynesBenzoxazinesCyclopropanesefavirenzHIV Protease InhibitorsLopinavirReverse Transcriptase InhibitorsRitonavirRNA, Viral

Identifiers

PMID21941167
PMCPMC3572727
OpenAlexW1965602853

What OpenQuestion holds

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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.