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Impacts of HIV Treatment Regimens on Archived Drug Resistance

10. juni 2026 opdateret af: Shui-Shan Lee, MD, Chinese University of Hong Kong

Impact of Antiretroviral Therapy (ART) Switch on Archived HIV-1 Drug Resistance in Virally Suppressed Patients: A Prospective Cohort Study

The study aims to determine the prevalence of drug resistance mutation (DRM) in virally suppressed HIV infection, and the impacts of regimen change and the presence of low level viremia. Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression would be recruited. Cases are patients planning for regimen switch, while controls are those with and without low level viraemia (LLV) not planned for switch. Blood samples would be collected before and after switch. Sequencing would be performed to identify DRM present in HIV-1 proviral DNA.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Aim/objectives: With the aim of determining the impact of antiretroviral regimen and switch on archived HIV-1 drug resistance mutation (DRM), the study's objectives are, to: (a) estimate the prevalence of DRM in virally suppressed HIV infection; (b) assess changes in archived resistance before and after switch; and (c) identify predictors of archived DRM after regimen switch.

Design: A prospective observational study

Setting: All HIV specialist clinic services in Hong Kong

Methods: Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression who are planned for regimen switch would be recruited. Controls are patients with and without low level viraemia (LLV) not planned for switch, matched by antiretroviral regimen. Blood samples would be collected before switch, shortly and then 2-3 years after switch. Nanopore sequencing would be performed to identify DRM present in HIV-1 proviral DNA. Transcription of relevant clinical record data would be made to contribute to statistical and phylogenetic analyses

Main outcome measures: Change in DRM frequency between baseline and followups at (a) short term and long term; (b) occurrence of virological failure and time to failure; (c) difference in DRM frequency between presence and absence of LLV, and switched and non-switched patients.

Anticipated outcome: The study results would determine if archived resistance clearance would change following ART switch, identify factors associated with persistence of archived resistance, and inform management on the application of proviral DNA testing in clinical practice.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

420

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Hong Kong
      • Hong Kong, Hong Kong, Kina, 0000
        • Rekruttering
        • S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients living with HIV and who are attendees of HIV specialist clinics in the public service in Hong Kong

Beskrivelse

Inclusion Criteria:

  • Patients living with HIV who are (a) aged 18 or above, (b) on antiretroviral therapy, (c) has viral load <20 copies/mL at 2 time points for ≥6 months, (d) planning regimen switch.
  • Patients for inclusion in the control group meet the same criteria (a) but they are not planned for switch. Controls include patients with low level viremia (LLV) as defined as ≥2 consecutive viral load level between 21 and 200 copies/mL in the preceding 2 years.

Exclusion Criteria:

  • Patients living with HIV who (a) are pregnant, (b) have virologic failure, (c) are suffering from concurrent opportunistic infections, (d) are prisoners , (e) are unable to give consent, and (f) have mental illnesses.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients on ART planning for regimen switch
virally suppressed with viral undetectable at 2 consecutive timepoints prior to enrolment
Patients on ART not for regimen switch
with and without low level viraemia prior to enrolment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportional difference of drug resistance mutation at short term after regimen switch
Tidsramme: from enrolment to 3-6 months
Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and short term (3-6 months) after regimen switch
from enrolment to 3-6 months
Proportional difference of drug resistance mutation at long term after regimen switch
Tidsramme: From enrolment to 2-3 years after regimen switch
Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and long term (2-3 years) after regimen switch
From enrolment to 2-3 years after regimen switch

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of drug resistance mutation
Tidsramme: at enrolment
Percentage of patients on antiretroviral therapy with drug resistance mutation (DRM) detected by proviral DNA testing at baseline
at enrolment
Proportional Difference of drug resistance mutation prevalence between patients with and without by low level viremia
Tidsramme: at enrolment
Percentage difference in the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing between the presence and absence of low level viremia at baseline
at enrolment

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of virologic failure
Tidsramme: From enrolment to 2-3 years
Prevalence of virologic failure in patients on antiretroviral therapy at 2-3 years after enrolment
From enrolment to 2-3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese University of Hong Kong

Efterforskere

  • Ledende efterforsker: Shui Shan Lee, MD, S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2025

Primær færdiggørelse (Anslået)

30. september 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HK HIV archived DRM

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual data are protected as per provision of the approval of the Ethics Committee

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