Evidence map›Paper›PMID 31373919›Full record

Trial reportAIDS (London, England)2019

Time to viral rebound and safety after antiretroviral treatment interruption in postpartum women compared with men.

Catherine N Le, Paula Britto, Sean S Brummel, Risa M Hoffman, Jonathan Z Li, Patricia M Flynn, Taha E Taha, Anne Coletti, Mary Glenn Fowler, Ronald J Bosch and 4 more

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

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

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

  1. Pooled it
  2. Trial
  3. The HIV Reservoir and Immune Landscape Across the Life Course of Women: Implications for Cure Strategies.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
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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.

Catherine N LeaUniversity of California Los Angeles, Los Angeles, California bHarvard T.H. Chan School of Public Health cBrigham and Women's Hospital, Boston, Massachusetts dSt. Jude Children's Research Hospital, Memphis, Tennessee eJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland fFHI 360, Durham, North Carolina gJohns Hopkins U. School of Medicine, Baltimore, Maryland hMassachusetts General Hospital and Ragon Institute, Harvard Medical School, Boston, Massachusetts iDAIDS, NIAID, Bethesda, Maryland, USA jAnova Health Institute, Johannesburg kSchool of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Paula Britto
Sean S Brummel
Risa M Hoffman
Jonathan Z Li
Patricia M Flynn
Taha E Taha
Anne Coletti
Mary Glenn Fowler
Ronald J Bosch
Rajesh T Gandhi
Karin L Klingman
James A McIntyre
Judith S Currier

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
LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
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
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
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
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARY Glenn Fowler, Philippa Musoke · 2012 to 2026
$34.8M
Postdoctoral Training in Global AIDS Prevention ResearchT32MH080634 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI JESSE LAWTON CLARK, Pamina Mae Gorbach · 2007 to 2026
$6.4M
BIOMEDICAL INFORMATION DEVELOPMENT IN SUB-SAHARAN AFRICAD43TW001081 · FIC · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 1998 to 2003
$435k
FIC NIH HHS D43 TW001081NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI069530NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001INIMH NIH HHS T32 MH080634
6 · The paper itself

Abstract

OBJECTIVE(S): The short-term safety of treatment interruptions, a necessary part of cure studies, is not well established, particularly in women. We explored viral rebound kinetics and safety in a group of postpartum women discontinuing ART and compared results to men in historical interruption trials.

designProspective evaluation of time to virologic rebound.

methodsOne thousand and seventy-six asymptomatic, virally suppressed, postpartum women living with HIV enrolled in the PROMISE trial with baseline CD4 cell counts at least 350 cells/μl underwent antiretroviral treatment (ART) discontinuation. Proportion with virologic suppression at weeks 4 and 12 were compared with participants in ACTG treatment interruption trials (91% male population).

resultsIn PROMISE, using interval censored methods, the estimated median time to HIV viral rebound was 2 weeks. An estimated 6% of women would remain virally suppressed at 30 weeks. Of those who had viral rebound by 30 weeks (N = 993), less than 4% experienced grade 3 or higher laboratory events, and 1% experienced WHO stage 2 or higher clinical events. Overall, less than 1% of participants progressed from WHO Stage 1 to Stage 2 or higher after discontinuation of ART, and 3.9% experienced a decline in CD4 cell count to less than 350 cells/μl or local treatment guidelines. A significantly higher proportion of women in PROMISE (25.4%) were virologically suppressed (<400 copies/ml) at 12 weeks compared with ACTG NWCS 371 participants (6.4%).

conclusionTemporary treatment interruptions in healthy, HIV-infected women with high CD4 cell counts can be well tolerated. Potential sex differences need to be considered in cure studies examining time to virologic rebound.

Indexed as

Postpartum PeriodViral LoadAdolescentAdultAgedAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCD4 Lymphocyte CountDisease ProgressionDrug Administration ScheduleFemaleHIV-1HIV InfectionsHumansMaleMiddle AgedAnti-HIV AgentsRNA, Viral

Identifiers

PMID31373919
PMCPMC6832824

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Registered trials

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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.