Evidence map›Paper›PMID 22180621›Full record

Trial reportThe Journal of infectious diseases2012

The setpoint study (ACTG A5217): effect of immediate versus deferred antiretroviral therapy on virologic set point in recently HIV-1-infected individuals.

Christine M Hogan, Victor Degruttola, Xin Sun, Susan A Fiscus, Carlos Del Rio, C Bradley Hare, Martin Markowitz, Elizabeth Connick, Bernard Macatangay, Karen T Tashima and 6 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00090779 (The SETPOINT Study - A Randomized Study of the Effect of Immediate Treatment With Potent Antiretroviral Therapy Versus Observation With Treatment as Indicated in Newly Infected HIV-1 Infected Subjects), which is not on this map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing 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.

NCT00090779 phase2terminatednot on this map

The SETPOINT Study - A Randomized Study of the Effect of Immediate Treatment With Potent Antiretroviral Therapy Versus Observation With Treatment as Indicated in Newly Infected HIV-1 Infected Subjects: Does Early Therapy After the Virologic Setpoint?

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2005 to 2011Enrolled130ConditionsHIV InfectionsArmsEmtricitabine/ tenofovir disoproxil fumarate, Lopinavir/Ritonavir
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Short-course antiretroviral therapy in primary HIV infection.The New England journal of medicine · 2013
    Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. The costs of HIV treatment and care in Ghana.AIDS (London, England) · 2017
    Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Christine M HoganDepartment of Medicine, Medical College of Wisconsin, Milwaukee, USA. chogan@mcw.edu
Victor Degruttola
Xin Sun
Susan A Fiscus
Carlos Del Rio
C Bradley Hare
Martin Markowitz
Elizabeth Connick
Bernard Macatangay
Karen T Tashima
Beatrice Kallungal
Rob Camp
Tia Morton
Eric S Daar
Susan Little
A5217 Study Team

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
ZONA-FREE HAMSTER OVA ASSAY AS AN INDICATOR OF MALE FERTILITYM01RR000425 · NCRR · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI ANDERSON, GAIL V · 1985 to 2011
$74.2M
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Carlos del Rio · 2002 to 2026
$74.0M
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
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
ZOPOLRESTAT PHARMACOKINETICS IN DIABETICS WITH VARYING RENAL FUNCTIONM01RR000051 · NCRR · UNIVERSITY OF COLORADO DENVER · PI KOSMISKI, LISA A. · 1985 to 2008
$52.6M
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
INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
NCATS NIH HHS UL1 TR000454NCRR NIH HHS 5-MO1 RR00044NCRR NIH HHS KL2 RR025009NCRR NIH HHS M01 RR000044NCRR NIH HHS M01 RR000051NCRR NIH HHS M01 RR000425NCRR NIH HHS M01 RR00051NCRR NIH HHS RR00425NCRR NIH HHS UL1 RR025009NCRR NIH HHS UL1 RR025014NCRR NIH HHS UL1-RR-025014NCRR NIH HHS UL1 RR025747NCRR NIH HHS UL 1RR025747NCRR NIH HHS UL1 RR025780NIAID NIH HHS 5-U01 AI069423NIAID NIH HHS 5UO1 AI069418NIAID NIH HHS 5UO1 AI069502NIAID NIH HHS AI047033NIAID NIH HHS AI050410NIAID NIH HHS AI 069424NIAID NIH HHS AI 069434NIAID NIH HHS AI 069471NIAID NIH HHS AI069474NIAID NIH HHS AI069477NIAID NIH HHS AI 069495NIAID NIH HHS AI25859NIAID NIH HHS AI27664NIAID NIH HHS AI27665NIAID NIH HHS AI43638NIAID NIH HHS AI46370NIAID NIH HHS AI68634NIAID NIH HHS AI69432NIAID NIH HHS AI69472NIAID NIH HHS AI74621NIAID NIH HHS P01 AI041534NIAID NIH HHS P01 AI055356NIAID NIH HHS P01 AI074621NIAID NIH HHS P01 AI55356NIAID NIH HHS P30 AI045008NIAID NIH HHS P30-AI-045008-12NIAID NIH HHS P30 AI050409NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI047033NIAID NIH HHS R24 AI106039NIAID NIH HHS U01 AI025859NIAID NIH HHS U01 AI027664NIAID NIH HHS U01 AI027665NIAID NIH HHS U01 AI041534NIAID NIH HHS U01 AI043638NIAID NIH HHS U01AI043638NIAID NIH HHS U01 AI046370NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069418NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069434NIAID NIH HHS U01 AI069438NIAID NIH HHS U01AI069438NIAID NIH HHS U01 AI069447NIAID NIH HHS U01- AI069447NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069477NIAID NIH HHS U01 AI069495NIAID NIH HHS U01 AI069502NIAID NIH HHS U01 AI069511NIAID NIH HHS U01AI069511-02NIAID NIH HHS U01-AI-096497-05NIAID NIH HHS U01 AI69450NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069434NIAID NIH HHS UM1 AI069447NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069477NIAID NIH HHS UM1 AI069495PHS HHS A106943-01
6 · The paper itself

Abstract

backgroundThe benefits of antiretroviral therapy during early human immunodeficiency virus type 1 (HIV-1) infection remain unproved.

methodsA5217 study team randomized patients within 6 months of HIV-1 seroconversion to receive either 36 weeks of antiretrovirals (immediate treatment [IT]) or no treatment (deferred treatment [DT]). Patients were to start or restart antiretroviral therapy if they met predefined criteria. The primary end point was a composite of requiring treatment or retreatment and the log(10) HIV-1 RNA level at week 72 (both groups) and 36 (DT group).

resultsAt the June 2009 Data Safety Monitoring Board (DSMB) review, 130 of 150 targeted participants had enrolled. Efficacy analysis included 79 individuals randomized ≥72 weeks previously. For the primary end point, the IT group at week 72 had a better outcome than the DT group at week 72 (P = .005) and the DT group at week 36 (P = .002). The differences were primarily due to the higher rate of progression to needing treatment in the DT group (50%) versus the IT (10%) group. The DSMB recommended stopping the study because further follow-up was unlikely to change these findings.

conclusionsProgression to meeting criteria for antiretroviral initiation in the DT group occurred more frequently than anticipated, limiting the ability to evaluate virologic set point. Antiretrovirals during early HIV-1 infection modestly delayed the need for subsequent treatment. CLINICAL TRIALS REGISTRATION: NCT00090779.

Indexed as

Viral LoadAdenineAdultAnti-HIV AgentsDeoxycytidineDisease ProgressionDrug Administration ScheduleDrug CombinationsDrug Therapy, CombinationEmtricitabineFemaleHIV-1HIV InfectionsHumansLopinavirMaleAdenineAnti-HIV AgentsDeoxycytidineDrug CombinationsEmtricitabineLopinavirlopinavir-ritonavir drug combinationOrganophosphonatesRitonavirRNA, ViralTenofovir

Identifiers

PMID22180621
PMCPMC3242744

What OpenQuestion holds

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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.