Impacts of HIV Treatment Regimens on Archived Drug Resistance

NCT07643948 | Recruiting

• 1 other identifier: HK HIV archived DRM
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV -1 Infection; Antiretroviral Therapy; Drug Resistance, Microbial

Keywords

antiretroviral therapy; regimen switch; archived resistance; low level viremia; proviral DNA; HIV infection

Outcome Measures

Primary Outcomes (2)

• Proportional difference of drug resistance mutation at short term after regimen switch

  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

  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

Secondary Outcomes (2)

• Prevalence of drug resistance mutation

  at enrolment

• Proportional Difference of drug resistance mutation prevalence between patients with and without by low level viremia

  at enrolment

Other Outcomes (1)

• Prevalence of virologic failure

  From enrolment to 2-3 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients living with HIV and who are attendees of HIV specialist clinics in the public service in Hong Kong

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong

Hong Kong, Hong Kong, 0000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Shui Shan Lee, MD

  S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shui Shan Lee, MD

CONTACT

+852 22528812; sslee@cuhk.edu.hk

Ngai Sze Wong, PhD

CONTACT

+852 22528862; candy_wong@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)