Evidence map›Paper›PMID 23323897›Full record

Trial reportThe New England journal of medicine2013

Short-course antiretroviral therapy in primary HIV infection.

SPARTAC Trial Investigators, Sarah Fidler, Kholoud Porter, Fiona Ewings, John Frater, Gita Ramjee, David Cooper, Helen Rees, Martin Fisher, Mauro Schechter and 11 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 119 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 4 pooled it
15.5field-weighted citation impact, top 1% 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.

NCT02336074 phase2completednot on this mapstarted 2015, after this paper: background citation

Research In Viral Eradication of HIV Reservoirs

TypeinterventionalSponsorImperial College LondonRan2015 to 2023Enrolled60ConditionsHIVArmsCombination Antiretroviral Therapy (cART), Raltegravir, Vorinostat, ChAdV63.HIVconsv (ChAd), MVA.HIVconsv (MVA)
NCT04319367 phase2recruitingnot on this mapstarted 2021, after this paper: background citation

A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo in Treated Primary or Early Stage HIV Infection on Viral Control Off ART

TypeinterventionalSponsorImperial College LondonRan2021 to 2027Enrolled72ConditionsHIV/AIDS and InfectionsArmsInvestigational Medicinal Product
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 4 syntheses or guidelines pooled it, 216 citations in OpenAlex.

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  7. Epigenetic scars of CD8Nature immunology · 2021
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59 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 1 institution in 2 countries.

SPARTAC Trial Investigators
Sarah Fidler
Kholoud Porter
Fiona Ewings
John Frater
Gita Ramjee
David Cooper
Helen Rees
Martin Fisher
Mauro Schechter
Pontiano Kaleebu
Giuseppe Tambussi
Sabine Kinloch
Jose M Miro
Anthony Kelleher
Myra McClure
Steve Kaye
Michelle Gabriel
Rodney Phillips
Jonathan Weber
Abdel Babiker
Apple (Israel) · IL

Funding

Medical Research Council G108/626Medical Research Council MC_U122886352Medical Research Council MC_UU_12023/16Wellcome Trust 069598Wellcome Trust 069598/Z/02/Z
6 · The paper itself

Abstract

backgroundShort-course antiretroviral therapy (ART) in primary human immunodeficiency virus (HIV) infection may delay disease progression but has not been adequately evaluated.

methodsWe randomly assigned adults with primary HIV infection to ART for 48 weeks, ART for 12 weeks, or no ART (standard of care), with treatment initiated within 6 months after seroconversion. The primary end point was a CD4+ count of less than 350 cells per cubic millimeter or long-term ART initiation.

resultsA total of 366 participants (60% men) underwent randomization to 48-week ART (123 participants), 12-week ART (120), or standard care (123), with an average follow-up of 4.2 years. The primary end point was reached in 50% of the 48-week ART group, as compared with 61% in each of the 12-week ART and standard-care groups. The average hazard ratio was 0.63 (95% confidence interval [CI], 0.45 to 0.90; P=0.01) for 48-week ART as compared with standard care and was 0.93 (95% CI, 0.67 to 1.29; P=0.67) for 12-week ART as compared with standard care. The proportion of participants who had a CD4+ count of less than 350 cells per cubic millimeter was 28% in the 48-week ART group, 40% in the 12-week group, and 40% in the standard-care group. Corresponding values for long-term ART initiation were 22%, 21%, and 22%. The median time to the primary end point was 65 weeks (95% CI, 17 to 114) longer with 48-week ART than with standard care. Post hoc analysis identified a trend toward a greater interval between ART initiation and the primary end point the closer that ART was initiated to estimated seroconversion (P=0.09), and 48-week ART conferred a reduction in the HIV RNA level of 0.44 log(10) copies per milliliter (95% CI, 0.25 to 0.64) 36 weeks after the completion of short-course therapy. There were no significant between-group differences in the incidence of the acquired immunodeficiency syndrome, death, or serious adverse events.

conclusionsA 48-week course of ART in patients with primary HIV infection delayed disease progression, although not significantly longer than the duration of the treatment. There was no evidence of adverse effects of ART interruption on the clinical outcome. (Funded by the Wellcome Trust; SPARTAC Controlled-Trials.com number, ISRCTN76742797, and EudraCT number, 2004-000446-20.).

Indexed as

AdultAnti-Retroviral AgentsCD4 Lymphocyte CountDisease ProgressionDrug Administration ScheduleFemaleFollow-Up StudiesHIVHIV InfectionsHumansMaleMiddle AgedRNA, ViralYoung AdultAnti-Retroviral AgentsRNA, Viral

Identifiers

PMID23323897
PMCPMC4131004
OpenAlexW2139217795

What OpenQuestion holds

Textmetadata
LicenceTDM
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.