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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Shui Shan Lee, MD
sslee@cuhk.edu.hk
+852 22528812
Backup
Ngai Sze Wong, PhD
candy_wong@cuhk.edu.hk
+852 22528862
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 420
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov

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