Impacts of HIV Treatment Regimens on Archived Drug Resistance
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 p
| Condition(s) | HIV -1 Infection, Antiretroviral Therapy, Drug Resistance, Microbial |
|---|---|
| Status | Recruiting |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Chinese University of Hong Kong |
| Locations | Hong Kong, Hong Kong, China |
| Start date | 2025-10-01 |
| NCT ID | NCT07643948 |
| Official listing | https://clinicaltrials.gov/study/NCT07643948 |