HIV -1 InfectionAntiretroviral TherapyDrug Resistance, Microbial
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportional difference of drug resistance mutation at short term after regimen switch — 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
Proportional difference of drug resistance mutation at long term after regimen switch — 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
Trial sites (1)
Facility
City
Region
Status
S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
Hong Kong
Hong Kong
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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