Evidence map›Paper›PMID 32049773›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2020

Brief Report: Sex Differences in Outcomes for Individuals Presenting for Third-Line Antiretroviral Therapy.

Catherine Godfrey, Michael D Hughes, Justin Ritz, Lara Coelho, Robert Gross, Robert Salata, Rosie Mngqibisa, Carole L Wallis, Makanga E Mumbi, Mitch Matoga and 7 more

Open access · greenAbstract read
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 38% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Where are we with understanding of COVID-19?Advances in biological regulation · 2020
    Review
  6. Where are we with understanding of COVID-19?Advances in biological regulation · 2020
    Review
  7. 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

17 authors at 12 institutions in 5 countries.

Catherine GodfreyDivision of AIDS NIAID, NIH, Bethesda, MD.
Michael D HughesHarvard T.H. Chan School of Public Health, Boston, MA.
Justin RitzHarvard T.H. Chan School of Public Health, Boston, MA.
Lara CoelhoInstituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil.
Robert GrossUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
Robert SalataCase Western Reserve University School of Medicine, Cleveland, OH.
Rosie MngqibisaDurban International CRS, Enhancing Care Foundation, Durban, South Africa.
Carole L WallisLancet Laboratories and BARC SA, Johannesburg, South Africa.
Makanga E MumbiKEMRI Centre for Global Health Research, Kisumu, Kenya.
Mitch MatogaUNC Project, Lilongwe, Malawi.
Selvamuthu PoongulaliCART Clinical Research Site, Voluntary Health Services, Chennai, India.
Marije Van SchalkwykFAM-CRU CRS, Stellenbosch University, Cape Town, South Africa.
Evelyn HoggSocial & Scientific Systems, Silver Spring, MD.
Courtney V FletcherUniversity of Nebraska Medical Center, Omaha, NE; and.
Beatriz GrinsztejnInstituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil.
Ann C CollierUniversity of Washington School of Medicine, Seattle, WA.
A5288 team
Harvard University · USInstituto Evandro Chagas · BRCase Western Reserve University · USKenya Medical Research Institute · KELancet Laboratories · ZAOffice of AIDS Research · USSocial and Scientific Systems (United States) · USStellenbosch University · ZAUniversity of Nebraska Medical Center · USUniversity of Pennsylvania · USUniversity of Washington · USVoluntary Health Services Hospital · IN

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
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI DAVID S METZGER · 1999 to 2026
$78.6M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Seattle Vaccine Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Rachel Ann Bender Ignacio, Margaret Juliana McElrath · 2012 to 2026
$24.4M
United States Military HIV Research Program (MHRP) Clinical Trials UnitUM1AI108568 · NIAID · WALTER REED ARMY INSTITUTE OF RESEARCH · PI Julie A. Ake, Merlin L Robb · 2014 to 2026
$24.3M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
NIAID NIH HHS P30 AI045008NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1 AI106716NIAID NIH HHS UM1 AI108568
6 · The paper itself

Abstract

backgroundSex differences in studies of antiretroviral (ART) drug exposure and treatment outcomes support the hypothesis that some ART combinations may not be well tolerated in women. We evaluated disparities in outcomes between men and women participating in ACTG A5288, an interventional strategy trial for individuals failing a protease inhibitor-based second-line ART regimen in low- and middle-income countries.

methodsParticipants were assigned to one of 4 cohorts (A-D) based on resistance profiles and ART history. Cohort A had no lopinavir/ritonavir (LPV/r) resistance and stayed on their second-line regimen, and cohorts B, C, and D had increasing resistance and accessed novel ART regimens. In this secondary analysis, we evaluated sex differences in the primary endpoint, HIV-1 RNA ≤200 copies/mL at week 48; confirmed virologic failure ≥1000 copies/mL (VF); and clinical outcomes and adverse events (intent-to-treat).

resultsWomen made up 258/545 (47%) of the study population. More women than men were assigned to cohort A. Median follow-up was 72 weeks. Fewer women than men had HIV-1 RNA ≤200 copies/mL at week 48: 39% vs. 49% in cohort A and 83% vs. 89% in cohorts B, C, and D combined. More women experienced VF, grade ≥3 signs and symptoms, but similar grade ≥3 diagnoses or laboratory abnormalities.

conclusionsMore women than men entered the study with a resistance profile suggesting that their second-line regimen could have been effective in maintaining virologic suppression. The more frequent occurrence of grade ≥3 signs and symptoms in women suggests that tolerability issues were under recognized in women on protease inhibitor-based therapy.

Indexed as

AdultAnti-HIV AgentsCohort StudiesDeveloping CountriesDrug CombinationsDrug Resistance, ViralFemaleHIV-1HIV InfectionsHumansLopinavirMaleReverse Transcriptase InhibitorsRitonavirSex FactorsTreatment OutcomeAnti-HIV AgentsDrug CombinationsLopinavirlopinavir-ritonavir drug combinationReverse Transcriptase InhibitorsRitonavir

Identifiers

PMID32049773
PMCPMC7228852
OpenAlexW3006654921

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.