Evidence map›Paper›PMID 22441252›Full record

ArticleAIDS (London, England)2012

Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings.

John A Bartlett, Heather J Ribaudo, Carole L Wallis, Evgenia Aga, David A Katzenstein, Wendy S Stevens, Michael R Norton, Karin L Klingman, Mina C Hosseinipour, John A Crump and 4 more

2 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in AIDS (London, England), 2012. 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 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–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.

NCT00357552 nacompletednot on this map

A Pilot Study of Lopinavir/Ritonavir in Participants Experiencing Virologic Relapse on NNRTI-Containing Regimens

TypeinterventionalSponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsRan2008 to 2012Enrolled123ConditionsHIV InfectionsArmsEmtricitabine/Tenofovir disoproxil fumarate, Lopinavir/Ritonavir
NCT01905059 phase3completednot on this mapstarted 2014, after this paper: background citation

Multicenter, International, Prospective, Phase III, Randomized, Superiority Trial Comparing Two Maintenance Strategies With Mono or Bi-therapy of Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment Over a Period of 96 Weeks in Africa (Dakar, Bobo Dioulasso, Yaounde)

TypeinterventionalSponsorANRS, Emerging Infectious DiseasesRan2014 to 2017Enrolled265ConditionsHIV InfectionArmsmonoPI - boosted lopinavir or boosted darunavir, bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine
3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2024
    Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. HIV-1 drug resistance and resistance testing.Infection, genetics and evolution : journal of molecular epidemiology and evolutionary genetics in infectious diseases · 2016
    Review
  9. Article
  10. Assessment of non-standard HIV antiretroviral therapy regimens at Lighthouse Trust in Lilongwe, Malawi.Malawi medical journal : the journal of Medical Association of Malawi · 2016
    Article
  11. Observational
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Drug susceptibility and resistance mutations after first-line failure in resource limited settings.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014
    Article
  17. Review
  18. Article
  19. Article
  20. Review
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.

John A BartlettDuke University Medical Center, Durham, NC 27710, USA. jab5@duke.edu
Heather J Ribaudo
Carole L Wallis
Evgenia Aga
David A Katzenstein
Wendy S Stevens
Michael R Norton
Karin L Klingman
Mina C Hosseinipour
John A Crump
Khuanchai Supparatpinyo
Sharlaa Badal-Faesen
Beatrice A Kallungal
Nagalingeswaran Kumarasamy

Funding

Viral Sequencing CoreU19AI067854 · NIAID · DUKE UNIVERSITY · PI HAYNES, BARTON F. · 2006 to 2011
$290.5M
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI Susanna Naggie, GEORGIA Doris TOMARAS · 2005 to 2026
$50.5M
The Malawi Clinical Trials UnitU01AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 2007 to 2011
$46.7M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitU01AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 2007 to 2011
$19.3M
HIV/AIDS Clinical Trials UnitU01AI069484 · NIAID · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2007 to 2011
$14.6M
AIDS International Training and Research ProgramD43TW006732 · FIC · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2004 to 2012
$2.7M
The Impact and Society Ecology of Bacterial Zoonoses in Northern Tanzania: UnderR01TW009237 · FIC · DUKE UNIVERSITY · PI CRUMP, JOHN ANDREW · 2011 to 2014
$1.7M
Developing Research Capacity in Africa for Studies on HIV-Associated MalignanciesD43CA153722 · NCI · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2010 to 2013
$1.6M
New Mechanisms of Protease Inhibitors ResistanceR03AI116408 · NIAID · STANFORD UNIVERSITY · PI KATZENSTEIN, DAVID ALLENBERG · 2015 to 2016
$161k
FIC NIH HHS D43 TW006732FIC NIH HHS R01 TW009237NCI NIH HHS D43 CA153722NIAID NIH HHS P30 AI064518NIAID NIH HHS P30 AI64518NIAID NIH HHS R03 AI116408NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069432NIAID NIH HHS U01AI069432NIAID NIH HHS U01 AI069484NIAID NIH HHS U01 AI069518NIAID NIH HHS U01AI069518NIAID NIH HHS U01AI38858NIAID NIH HHS U19 AI067854PHS HHS T84HA21123
6 · The paper itself

Abstract

objectiveTo evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLSs).

designAn open-label pilot study of LPV/r monotherapy in participants on first-line nonnucleoside reverse transcriptase inhibitor three-drug combination ART with plasma HIV-1 RNA 1000-200 000  copies/ml.

methodsParticipants were recruited from five sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network. All participants received LPV/r 400/100  mg twice daily. The primary endpoint was remaining on LPV/r monotherapy without virologic failure at week 24. Participants with virologic failure were offered addition of emtricitabine and tenofovir (FTC/TDF) to LPV/r.

resultsMutations associated with drug resistance were encountered in nearly all individuals screened for the study. One hundred and twenty-three participants were enrolled, and 122 completed 24 weeks on study. A high proportion remained on LPV/r monotherapy without virologic failure at 24 weeks (87%). Archived samples with HIV-1 RNA levels less than 400  copies/ml at week 24 (n=102) underwent ultrasensitive assay. Of these individuals, 62 had levels less than 40  copies/ml and 30 had levels 40-200  copies/ml. Fifteen individuals experienced virologic failure, among whom 11 had resistance assessed and two had emergent protease inhibitor mutations. Thirteen individuals with virologic failure added FTC/TDF and one individual added FTC/TDF without virologic failure. At study week 48, 11 of 14 adding FTC/TDF had HIV-1 RNA levels less than 400  copies/ml.

conclusionIn this pilot study conducted in diverse RLS, LPV/r monotherapy as second-line ART demonstrated promising activity.

Indexed as

Acquired Immunodeficiency SyndromeAdenineAdultAfricaAnti-HIV AgentsDeoxycytidineDrug Administration ScheduleDrug Therapy, CombinationEmtricitabineFemaleHealth ResourcesHumansIndiaLopinavirMaleMedication AdherenceAdenineAnti-HIV AgentsDeoxycytidineEmtricitabineLopinavirOrganophosphonatesReverse Transcriptase InhibitorsRitonavirRNA, ViralTenofovir

Identifiers

PMID22441252
PMCPMC3443745

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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.