Impacts of HIV Treatment Regimens on Archived Drug Resistance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV -1 Infection, Antiretroviral Therapy, Drug Resistance, Microbial. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Antiretroviral Therapy (ART) Switch on Archived HIV-1 Drug Resistance in Virally Suppressed Patients: A Prospective Cohort Study
Overview
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.
Detailed description
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.
Primary outcome measures
- Proportional difference of drug resistance mutation at short term after regimen switch [Time frame: from enrolment to 3-6 months]
- Proportional difference of drug resistance mutation at long term after regimen switch [Time frame: From enrolment to 2-3 years after regimen switch]
Secondary outcome measures (2)
- Prevalence of drug resistance mutation [Time frame: at enrolment]
- Proportional Difference of drug resistance mutation prevalence between patients with and without by low level viremia [Time frame: at enrolment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07643948 · HK HIV archived DRM