Evidence map›Paper›PMID 26600459›Full record

Trial reportPloS one2015

A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection.

Joseph B Margolick, Linda Apuzzo, Joel Singer, Hubert Wong, Terry Lee, Joel E Gallant, Phillippe El-Helou, Mona R Loutfy, Anita Rachlis, Christopher Fraser and 4 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00106171 (A Randomized Trial of HAART in Acute/Early HIV Infection), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 90% 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.

NCT00106171 phase4completednot on this map

A Randomized Trial of HAART in Acute/Early HIV Infection

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2005 to 2012Enrolled113ConditionsHIV InfectionsArmsHighly active antiretroviral therapy (HAART)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

14 authors at 9 institutions in 2 countries.

Joseph B MargolickDepartment of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Linda ApuzzoDepartment of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Joel SingerCIHR Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
Hubert WongCIHR Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
Terry LeeCIHR Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
Joel E GallantDepartment of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, United States of America.
Phillippe El-HelouDepartment of Medicine, McMaster University, Hamilton, Ontario Canada.
Mona R LoutfyMaple Leaf Medical Clinic, Toronto, Ontario, Canada.
Anita RachlisSunnybrook Health Sciences, Toronto, Ontario, Canada.
Christopher FraserCool Aid Community Health Center, Victoria, British Columbia, Canada.
Kenneth KasperDepartment of Medical Microbiology, University of Manitoba, Winnipeg, Manitoba, Canada.
Cécile TremblayCentre de recherché du Centre Hospitalier de l' Université de Montréal, Montréal, Quebec, Canada.
Harout TossonianVancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada.
Brian ConwayVancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada.
HIV Legal Network · CAJohns Hopkins University · USVancouver Infectious Diseases Centre · CACentre Hospitalier de l’Université de Montréal · CAJohns Hopkins Medicine · USMaple Leaf Medical Clinic · CAMcMaster University · CASunnybrook Health Science Centre · CAUniversity of Manitoba · CA

Funding

Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
A randomized trial of HAART in acute/early HIV InfectionR01AI056990 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARGOLICK, JOSEPH B. · 2004 to 2008
$3.3M
NCRR NIH HHS UL1 RR025005NCRR NIH HHS UL1RR025005NIAID NIH HHS AI056990NIAID NIH HHS R01 AI056990
6 · The paper itself

Abstract

backgroundIt has been proposed that initiation of antiretroviral treatment (ART) very soon after establishment of HIV infection may be beneficial by improving host control of HIV replication and delaying disease progression.

methodsPeople with documented HIV infection of less than 12 months' duration in Baltimore MD and seven Canadian sites were randomized to either a) observation and deferred ART, or b) immediate treatment with ART for 12 months. All subjects not receiving ART were followed quarterly and permanent ART was initiated according to contemporaneous treatment guidelines. The endpoint of the trial was total ART-free time from study entry until initiation of permanent ART.

resultsOne hundred thirteen people were randomized, 56 to the observation arm and 57 to the immediate treatment arm. Twenty-three had acute (<2 months) infection and 90 early (2-12 months) infection. Of those randomized to the immediate treatment arm, 37 completed 12 months of ART according to protocol, 9 declined to stop ART after 12 months, and 11 were nonadherent to the protocol or lost to follow-up. Comparing those in the observation arm to either those who completed 12 months of ART or all 56 who were randomized to immediate ART, there was no significant difference between the arms in treatment-free interval after study entry, which was about 18 months in both arms.

conclusionsThis study did not find a benefit from administration of a brief, time-limited (12-month) course of ART in acute or early HIV infection.

trial registrationClinicalTrials.gov NCT00106171.

Indexed as

Antiretroviral Therapy, Highly ActiveAdolescentAdultAgedCD4 Lymphocyte CountFemaleHIV InfectionsHumansMaleMiddle AgedRetreatmentTime FactorsTreatment OutcomeViral LoadYoung Adult

Identifiers

PMID26600459
PMCPMC4658016
OpenAlexW2264919079

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.