Evidence map›Paper›PMID 22813645›Full record

Trial reportContemporary clinical trials2012

Statistical considerations for the HPTN 052 Study to evaluate the effectiveness of early versus delayed antiretroviral strategies to prevent the sexual transmission of HIV-1 in serodiscordant couples.

Ying Qing Chen, Benoit Masse, Lei Wang, San-San Ou, Xin Li, Deborah Donnell, Marybeth McCauley, Theresa Gamble, Heather J Ribauldo, Myron S Cohen and 1 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2012. 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
1.4field-weighted citation impact, top 20% 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, 21 citations in OpenAlex.

  1. Risk of sexual transmission of human immunodeficiency virus with antiretroviral therapy, suppressed viral load and condom use: a systematic review.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
    Pooled it
  2. Pooled it
  3. Antiretroviral Therapy for the Prevention of HIV-1 Transmission.The New England journal of medicine · 2016
    Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Unemployment, health, and education of HIV-infected males in Germany.International journal of public health · 2016
    Observational
  10. Article
  11. Article
  12. Article
  13. 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 at 6 institutions in 2 countries.

Ying Qing ChenStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. yqchen@fhcrc.org
Benoit Masse
Lei Wang
San-San Ou
Xin Li
Deborah Donnell
Marybeth McCauley
Theresa Gamble
Heather J Ribauldo
Myron S Cohen
Thomas R Fleming
Fred Hutch Cancer Center · USFamily Health International 360 · USCancer Research And Biostatistics · USUniversité de Montréal · CAUniversity of North Carolina at Chapel Hill · USUniversity of Washington · US

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
HIV Prevention trials Network (HPTN) Coordinating and Operations CenterU01AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI VERMUND, STEN H. · 2006 to 2010
$72.7M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
Leadership for HIV/AIDS Clinical Trials Networks; HIV Prevention Trials NetworkU01AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DONNELL, DEBORAH J · 2006 to 2010
$28.8M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Statistical Methods in HIV/AIDS ResearchR01AI089341 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI CHEN, YING QING · 2010 to 2012
$1.3M
NCATS NIH HHS UL1 TR000454NCI NIH HHS P30 CA015704NCRR NIH HHS UL1 RR025008NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI089341NIAID NIH HHS U01 AI068617NIAID NIH HHS U01-AI068617NIAID NIH HHS U01 AI068619NIAID NIH HHS U01-AI068619NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1-AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1-AI068619
6 · The paper itself

Abstract

The HIV Prevention Trial Network (HPTN) 052 Study is a Phase III, two-arm, controlled, open-labeled, randomized clinical trial designed to determine whether early antiretroviral therapy (ART) can prevent the sexual transmission of human immunodeficiency virus type 1 (HIV-1). A total of 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative were enrolled in four continents, nine countries and thirteen study sites. The HIV-1-positive partner was randomly assigned to either of the two arms: "immediate" (early) therapy with ART initiated upon enrollment plus HIV primary care, or "delayed" therapy with HIV primary care but ART initiated when the index case would have two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm(3), or develop an AIDS-defining illness. In this paper, we describe several key statistical considerations for the design of this landmark study. Despite that the observed event rates were lower than expected, which might have compromised the study power, an early release of the trial results in May 2011 showed an overwhelming 96% risk reduction for the immediate therapy in the prevention of genetically linked HIV-1 incident transmissions. Nevertheless, the durability of its long-term effectiveness is yet to be assessed. The HPTN 052 Study is still ongoing and will not complete till 2015.

Indexed as

Sexual PartnersAnti-Retroviral AgentsCD4 Lymphocyte CountDrug Administration ScheduleFemaleHIV-1HIV InfectionsHIV SeropositivityHumansMaleTime FactorsAnti-Retroviral Agents

Identifiers

PMID22813645
PMCPMC3468650
OpenAlexW2019822646

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.