Impacts of HIV Treatment Regimens on Archived Drug Resistance
Impact of Antiretroviral Therapy (ART) Switch on Archived HIV-1 Drug Resistance in Virally Suppressed Patients: A Prospective Cohort Study
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Shui Shan Lee, MD
- Telefonnummer: +852 22528812
- E-post: sslee@cuhk.edu.hk
Studer Kontakt Backup
- Navn: Ngai Sze Wong, PhD
- Telefonnummer: +852 22528862
- E-post: candy_wong@cuhk.edu.hk
Studiesteder
-
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Hong Kong
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Hong Kong, Hong Kong, Kina, 0000
- Rekruttering
- S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
-
Ta kontakt med:
- Shui Shan Lee, MD
- Telefonnummer: +852 22528812
- E-post: sslee@cuhk.edu.hk
-
Ta kontakt med:
- Ngai Sze Wong, PhD
- Telefonnummer: +852 22528862
- E-post: candy_wong@cuhk.edu.hk
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of virologic failure
Tidsramme: From enrolment to 2-3 years
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Prevalence of virologic failure in patients on antiretroviral therapy at 2-3 years after enrolment
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From enrolment to 2-3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shui Shan Lee, MD, S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i immunsystemet
- Infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- HIV-infeksjoner
Andre studie-ID-numre
- HK HIV archived DRM
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