How HIV Treatment Changes Affect Hidden Drug Resistance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll adults with HIV who are on antiretroviral therapy and have sustained viral suppression. It compares those planning a regimen switch with controls who are or are not experiencing low-level viremia, to see how archived drug resistance mutations change over time. Blood samples are collected before switch, shortly after, and again 2–3 years later, with nanopore sequencing used to identify resistance mutations in proviral DNA. The study will analyze how LLV and switching interact to influence archived resistance and subsequent virologic outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Shui Shan Lee, MD — S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong kong
• Study coordinator: Shui Shan Lee, MD
• Email: sslee@cuhk.edu.hk
• Phone: +852 22528812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.