Evidence map›Paper›PMID 19696651›Full record

Trial reportAIDS (London, England)2009

Antiretroviral therapy in acute and recent HIV infection: a prospective multicenter stratified trial of intentionally interrupted treatment.

Paul Volberding, Lisa Demeter, Ronald J Bosch, Evgenia Aga, Carla Pettinelli, Martin Hirsch, Mary Vogler, Ana Martinez, Susan Little, Elizabeth Connick and 1 more

3 registry-linked trialsAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in AIDS (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 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.

NCT00000940 phase2completednot on this map

A Phase II Trial to Evaluate the Safety and Efficacy of Induction Treatment With Lamivudine Plus Stavudine Plus Abacavir Plus Amprenavir/Ritonavir Followed by Supervised Treatment Interruption in Subjects With Acute HIV Infection or Recent Seroconversion

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran1999 to 2006Enrolled121ConditionsHIV InfectionsArmsRitonavir, Abacavir sulfate, Amprenavir, Lamivudine, Stavudine
NCT02042248 phase1completednot on this mapstarted 2014, after this paper: background citation

IGHID 1309 -A Phase I Study to Evaluate the Kinetics of the Immunologic Response and Virologic Impact of AGS-004 in HIV-Infected Individuals Suppressed on Antiretroviral Therapy Initiated During Acute and Chronic HIV Infection

TypeinterventionalSponsorCynthia L Gay, MDRan2014 to 2016Enrolled6ConditionsHIVArmsAGS-004
NCT02208167 phase1completednot on this mapstarted 2015, after this paper: background citation

IGHID 1320 - A Phase I Study to Evaluate the Safety, Immunologic, and Virologic Responses of HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) as a Therapeutic Strategy in HIV-Infected Individuals Started on Antiretroviral Therapy During Acute and Chronic Infection

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2015 to 2017Enrolled6ConditionsHIVArmsHXTC infusion
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Time to Viral Rebound After Interruption of Modern Antiretroviral Therapies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
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  14. Article
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  16. Viral and immune predictors of HIV posttreatment control.Current opinion in HIV and AIDS · 2025
    Review
  17. Article
  18. Article
  19. Demographics of Youth With Newly Diagnosed Acute/Recent HIV Infection in Adolescent Trials Network 147: Early Treatment of Acute HIV Infection.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2024
    Article
  20. 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.

Paul VolberdingUniversity of California-San Francisco, 4150 Clement Street, San Francisco, CA 94121, USA. Paul.volberding@va.gov
Lisa Demeter
Ronald J Bosch
Evgenia Aga
Carla Pettinelli
Martin Hirsch
Mary Vogler
Ana Martinez
Susan Little
Elizabeth Connick
ACTG 371 Team

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
Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
STATISTICAL AND DATA MANAGEMENT CENTERU01AI038855 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI HUGHES, MICHAEL DAVID · 1996 to 2006
$78.1M
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 UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
Primary Infection Resource Consortium (PIRC)R24AI106039 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LITTLE, SUSAN JANET · 2013 to 2021
$23.1M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitU01AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 2007 to 2011
$19.3M
Colorado AIDS Clinical Trials UnitU01AI069450 · NIAID · UNIVERSITY OF COLORADO DENVER · PI CAMPBELL, THOMAS B. · 2007 to 2011
$8.3M
Colorado AIDS Clinical Trials UnitUM1AI069450 · NIAID · UNIVERSITY OF COLORADO DENVER · PI CAMPBELL, THOMAS B. · 2012 to 2013
$2.6M
NIAID NIH HHS AI-38855NIAID NIH HHS AI-38858NIAID NIH HHS AI-68634NIAID NIH HHS AI-68636NIAID NIH HHS AI-69432NIAID NIH HHS AI 69450NIAID NIH HHS P30 AI027763NIAID NIH HHS R24 AI106039NIAID NIH HHS U01 AI038855NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069450NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069450
6 · The paper itself

Abstract

backgroundAntiretroviral therapy in early HIV infection may enhance outcome and viral control may be better in acute versus recent infection 24 weeks after treatment interruption.

methodsA prospective trial of treatment stratified by acute versus recent HIV-1 infection. If HIV viral load <50 copies/ml after at least 52 weeks, treatment was interrupted. If viremia rebounded, treatment and interruption were repeated. The primary endpoint was maintaining viral load less than 5000 copies/ml for 24 weeks following treatment interruption.

resultsOf the 121 patients enrolled at 15 sites, ninety-five percent were men, median age was 34 years; 69% were white. Median viral load was higher in acute HIV-1 infection (210 000 copies/ml) than recent HIV-1 infection (43 000 copies/ml). The 73 primary endpoint patients (28 acute HIV-1 infection, 45 recent HIV-1 infection) had significantly higher baseline CD4 T-cell counts (P = 0.044) and lower viral load (P = 0.016). The primary endpoint was achieved in 29 (40%) of the 73 and in 24% of the 121 enrolled overall. There was no significant outcome difference (P = 0.81) between the acute HIV-1 infection [43%, 95% confidence interval (CI) 24-63%] and recent HIV-1 infection (38%, 95% CI 24-53%) groups. Differences after longer follow-up can not be ascertained by this trial. Baseline viral load less than 100 000/ml 22/46 (48%) compared with more than 100 000/ml, 7/27 (26%) and higher baseline CD4 immune activation predicted success.

conclusionForty percent of patients treated during acute HIV-1 infection or recent HIV-1 infection sustained a viral load less than 5000 copies/ml after 24 weeks of treatment interruption.

Indexed as

Acute DiseaseAdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCD4 Lymphocyte CountDrug Administration ScheduleFemaleHIV-1HIV InfectionsHumansMaleProspective StudiesRNA, ViralTreatment OutcomeViral LoadViremiaAnti-HIV AgentsRNA, Viral

Identifiers

PMID19696651
PMCPMC2888600

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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.