Evidence map›Paper›PMID 30798695›Full record

Trial reportJournal of the International Association of Providers of AIDS Care

HIV Viral Dynamics of Lopinavir/Ritonavir Monotherapy as Second-Line Treatment: A Prospective, Single-Arm Trial.

Cassidy W Claassen, David Keckich, Chidi Nwizu, Alash'le Abimiku, Donald Salami, Michael Obiefune, Bruce L Gilliam, Anthony Amoroso

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the International Association of Providers of AIDS Care. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Cassidy W Claassen1 Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.ORCID 0000-0001-5059-7894
David Keckich2 Northern Arizona Healthcare, Cottonwood, AZ, USA.
Chidi Nwizu1 Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Alash'le Abimiku1 Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Donald Salami4 University of Maryland, Maryland Global Initiatives Corporation, Abuja, Nigeria.
Michael Obiefune3 Center for Clinical Care and Clinical Research, Abuja, Nigeria.
Bruce L Gilliam1 Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.
Anthony Amoroso1 Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCharacterizing viral response to lopinavir/ritonavir (LPV/r) monotherapy as second-line treatment may guide recommendations for resource-limited settings (RLS).

methodsWe conducted a 48-week prospective, single-arm study of LPV/r monotherapy in patients failing first-line therapy in Nigeria. The primary outcome was sustained HIV-1 viral load (VL) <400 copies/mL at 48 weeks.

resultsOf 30 enrolled patients, 28 (93%) achieved viral suppression on LPV/r, while 29 (96%) experienced low-level viremia. At 48 weeks, 9 (30%) met the primary outcome of sustained viral suppression; 14 (47%) patients were suppressed on LPV/r in a snapshot analysis. Detectable VLs at 12 and 24 weeks were strongly associated with treatment failure at 48 weeks. New resistance mutations were not detected. The trial was stopped early due to treatment failure.

conclusionIn this study, the rate of virologic failure among patients on a second-line lopinavir monotherapy regimen was relatively high and predicted by early detectable viremia. However, no LPV/r-associated resistance mutations were detected despite fluctuating low-level viremia, demonstrating the high genetic barrier to resistance of the protease inhibitor class which could be useful in RLS.

Indexed as

Sustained Virologic ResponseAdultEarly Termination of Clinical TrialsFemaleHIV-1HIV InfectionsHIV Protease InhibitorsHumansLopinavirMaleProof of Concept StudyProspective StudiesRitonavirTreatment FailureViral LoadViremiaHIV Protease InhibitorsLopinavirRitonavirboosted protease inhibitor monotherapyHIVlopinavir/ritonavir monotherapyresource-limited settingssecond-line antiretroviral therapy

Identifiers

PMID30798695
PMCPMC6748552

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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.