Impacts of HIV Treatment Regimens on Archived Drug Resistance (NCT07643948) | Clinical Trial Compass
RecruitingNot Applicable
Impacts of HIV Treatment Regimens on Archived Drug Resistance
China420 participantsStarted 2025-10-01
Plain-language 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
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at drug resistance mutations that get 'archived' — meaning stored in my body — when I switch HIV regimens. Can you explain whether I have any existing archived resistance mutations that might make this study relevant to my situation?
2The trial is measuring resistance changes both short-term and long-term after a regimen switch. Does that mean I would need to switch my current HIV treatment as part of participating, and if so, how might that affect my viral control?
3Since this trial doesn't have a numbered phase, it seems more focused on observing and measuring what happens rather than testing a new drug. Can you help me understand what I would actually be asked to do, like blood draws or monitoring visits, and how that fits into my current care schedule?
4The study is tracking drug resistance mutations over time after a regimen switch. If resistance mutations are found or increase during the study, would I be told right away and would my treatment be adjusted?
5Given that this research is focused on understanding resistance patterns rather than offering a new treatment, is there a direct benefit to me as a participant, or would the main benefit be contributing to knowledge that helps future patients — and does that change how we should think about whether it's worth my time to join?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportional difference of drug resistance mutation at short term after regimen switch
Timeframe: from enrolment to 3-6 months
2
Proportional difference of drug resistance mutation at long term after regimen switch
Timeframe: From enrolment to 2-3 years after regimen switch