Evidence map›Paper›PMID 34922614›Full record

Trial reportTrials2021

Resource and infrastructure challenges on the RESIST-2 Trial: an implementation study of drug resistance genotype-based algorithmic ART switches in HIV-2-infected adults in Senegal.

Dana N Raugi, Khardiata Diallo, Mouhamadou Baïla Diallo, Dominique Faye, Ousseynou Cisse, Robert A Smith, Fatima Sall, El Hadji Ibrahima Sall, Khadim Faye, Jean Philippe Diatta and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03394196 (Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 55% 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.

NCT03394196 naterminatednot on this map

Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program

TypeinterventionalSponsorUniversity of WashingtonRan2018 to 2020Enrolled152ConditionsHIV-2 InfectionArmsHIV-2 Genotypic Drug Resistance Testing using DBS, 2nd line ART ( Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID), 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID ), 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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 3 institutions in 2 countries.

Dana N RaugiDepartment of Medicine, Division of Allergy & Infectious Diseases, Center for Emerging & Re-Emerging Infectious Diseases, University of Washington, Seattle, WA, USA. raugid@uw.edu.ORCID http://orcid.org/0000-0001-6205-845X
Khardiata DialloService des Maladies Infectieuses et Tropicales, Ibrahima Diop Mar, Centre Hospitalier National Universitaire de Fann, Universite Cheikh Anta Diop de Dakar, Dakar, Senegal.
Mouhamadou Baïla DialloService des Maladies Infectieuses et Tropicales, Ibrahima Diop Mar, Centre Hospitalier National Universitaire de Fann, Universite Cheikh Anta Diop de Dakar, Dakar, Senegal.
Dominique FayeCentre de Sante de Ziguinchor, Ziguinchor, Senegal.
Ousseynou CisseCentre de Sante de Ziguinchor, Ziguinchor, Senegal.
Robert A SmithDepartment of Medicine, Division of Allergy & Infectious Diseases, Center for Emerging & Re-Emerging Infectious Diseases, University of Washington, Seattle, WA, USA.
Fatima SallService des Maladies Infectieuses et Tropicales, Ibrahima Diop Mar, Centre Hospitalier National Universitaire de Fann, Universite Cheikh Anta Diop de Dakar, Dakar, Senegal.
El Hadji Ibrahima SallCentre de Sante de Ziguinchor, Ziguinchor, Senegal.
Khadim FayeService des Maladies Infectieuses et Tropicales, Ibrahima Diop Mar, Centre Hospitalier National Universitaire de Fann, Universite Cheikh Anta Diop de Dakar, Dakar, Senegal.
Jean Philippe DiattaCentre de Sante de Ziguinchor, Ziguinchor, Senegal.
Binetou DiawService des Maladies Infectieuses et Tropicales, Ibrahima Diop Mar, Centre Hospitalier National Universitaire de Fann, Universite Cheikh Anta Diop de Dakar, Dakar, Senegal.
Jacques SambouCentre de Sante de Ziguinchor, Ziguinchor, Senegal.
Jean Jacques MalomarCentre de Sante de Ziguinchor, Ziguinchor, Senegal.
Stephen E HawesDepartment of Epidemiology, University of Washington, Seattle, WA, USA.
Moussa SeydiService des Maladies Infectieuses et Tropicales, Ibrahima Diop Mar, Centre Hospitalier National Universitaire de Fann, Universite Cheikh Anta Diop de Dakar, Dakar, Senegal.
Geoffrey S GottliebDepartment of Medicine, Division of Allergy & Infectious Diseases, Center for Emerging & Re-Emerging Infectious Diseases, University of Washington, Seattle, WA, USA.
University of Washington-Senegal HIV-2 Study Group
Centre Hospitalier National Universitaire de Fann · SNZiguinchor University · SNUniversity of Washington · US

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI CONNIE L CELUM · 1988 to 2026
$104.9M
Improving Diagnosis, Treatment & Detection of Drug Resistance in HIV-2 InfectionR01AI120765 · NIAID · UNIVERSITY OF WASHINGTON · PI Geoffrey Scott Gottlieb · 2015 to 2026
$8.9M
Antiretroviral Therapy for HIV-2 Infection in SenegalR01AI060466 · NIAID · UNIVERSITY OF WASHINGTON · PI GOTTLIEB, GEOFFREY SCOTT · 2005 to 2014
$6.5M
National Institutes of Health, National Institute of Allergy & Infectious Diseases 2R01-AI060466National Institutes of Health, National Institute of Allergy & Infectious Diseases R01-AI120765NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI060466NIAID NIH HHS R01 AI120765
6 · The paper itself

Abstract

backgroundSecond-line treatment of HIV-2 in resource-limited settings (RLS) is complicated by a lack of controlled trial data, limited availability of HIV-2-active antiretroviral drugs, and inadequate access to drug resistance testing. We conducted an implementation trial of a dried blood spot- (DBS) based, drug resistance genotype-informed antiretroviral therapy (ART) switching algorithm for HIV-2-infected patients in Senegal.

methodsHIV-2-infected adults initiating or receiving ART through the Senegalese national AIDS program were invited to participate in this single-arm trial. DBS from participants with virologic failure (defined as viral load (VL) > 250 copies/mL after > 6 months on the current ART regimen) were shipped to Seattle for genotypic drug resistance testing. Participants with evidence of drug resistance in protease or reverse transcriptase were switched to new regimens according to a pre-specified algorithm. Participant clinical and immuno-virologic outcomes were assessed, as were implementation challenges.

resultsWe enrolled 152 participants. Ten were initiating ART. The remainder were ART-experienced, with 91.0% virologically suppressed (< 50 copies/mL). Problems with viral load testing capability resulted in obtaining VL results for only 227 of 613 (37.0%) participant-visits. Six of 115 participants (5.2%) with VL available after > 6 months on current ART regimen experienced virologic failure, with per-protocol genotypic testing attempted. One additional test was performed for a participant with a VL of 222 copies/mL. Genotypes from three participants showed no evidence of major drug resistance mutations, two showed nucleoside reverse transcriptase inhibitor (NRTI) resistance, one showed both NRTI and protease inhibitor resistance, and one test failed. No integrase inhibitor resistance was observed. Five of six successfully-tested participants switched to the correct regimen or received additional adherence counseling according to the algorithm; the sixth was lost to follow-up. Follow-up VL testing was available for two participants; both of these were virally suppressed (< 10 copies/mL). The trial was terminated early due to the COVID-19 pandemic (which prevented further VL and genotypic testing), planned rollout of dolutegravir-based 1st-line ART, and funding.

conclusionsThe RESIST-2 trial demonstrated that a DBS-based genotypic test can be used to help inform second-line ART decisions as part of a programmatic algorithm in RLS, albeit with significant implementation challenges.

trial registrationClinicalTrials.gov NCT03394196 . Registered on January 9, 2018.

Indexed as

COVID-19HIV InfectionsDrug ResistanceGenotypeHIV-2HumansPandemicsSARS-CoV-2SenegalAntiretroviral therapyCOVID-19HIV-2HIV treatmentPoint-of-careViral suppression

Identifiers

PMID34922614
PMCPMC8683814
OpenAlexW4200071059

What OpenQuestion holds

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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.