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
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Shui Shan Lee, MD
- Numéro de téléphone: +852 22528812
- E-mail: sslee@cuhk.edu.hk
Sauvegarde des contacts de l'étude
- Nom: Ngai Sze Wong, PhD
- Numéro de téléphone: +852 22528862
- E-mail: candy_wong@cuhk.edu.hk
Lieux d'étude
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Hong Kong
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Hong Kong, Hong Kong, Chine, 0000
- Recrutement
- S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
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Contact:
- Shui Shan Lee, MD
- Numéro de téléphone: +852 22528812
- E-mail: sslee@cuhk.edu.hk
-
Contact:
- Ngai Sze Wong, PhD
- Numéro de téléphone: +852 22528862
- E-mail: candy_wong@cuhk.edu.hk
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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Patients on ART planning for regimen switch
virally suppressed with viral undetectable at 2 consecutive timepoints prior to enrolment
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Patients on ART not for regimen switch
with and without low level viraemia prior to enrolment
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportional difference of drug resistance mutation at short term after regimen switch
Délai: from enrolment to 3-6 months
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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
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from enrolment to 3-6 months
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Proportional difference of drug resistance mutation at long term after regimen switch
Délai: From enrolment to 2-3 years after regimen switch
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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
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From enrolment to 2-3 years after regimen switch
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Prevalence of drug resistance mutation
Délai: at enrolment
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Percentage of patients on antiretroviral therapy with drug resistance mutation (DRM) detected by proviral DNA testing at baseline
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at enrolment
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Proportional Difference of drug resistance mutation prevalence between patients with and without by low level viremia
Délai: at enrolment
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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
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at enrolment
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Prevalence of virologic failure
Délai: 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
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shui Shan Lee, MD, S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Maladies urogénitales
- Maladies génitales
- Maladies du système immunitaire
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Infections à VIH
Autres numéros d'identification d'étude
- HK HIV archived DRM
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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