Role of Viral Reservoir, Immune Activation and Depletion in Persistent Viremia Persistent Viremia… (NCT07015164) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Role of Viral Reservoir, Immune Activation and Depletion in Persistent Viremia Persistent Viremia in People Living With HIV on Antiretroviral Therapy
France80 participantsStarted 2025-06-10
Plain-language summary
Low-level HIV replication in a patient on effective antiretroviral therapy is a relatively frequent event, generating stress for both patient and physician, due to the fear of subsequent virological escape with emergence of resistant virus(es) and/or transmission of such virus(es) to partner(s). Understanding the origin of this low-level viral replication would enable informed therapeutic decisions to be made (therapeutic intensification, modification of antiretroviral (ARV) treatment with the use of molecules belonging to other therapeutic classes, or maintenance of the status quo), and reassure patients of the scientific rationale guiding their course of action.
This is a single-center, cross-sectional study designed to compare the parameters of the cellular viral reservoir between a group of participants with persistent viral replication under ARV treatment and a group of participants with perfect viral replication control (stable virological suppression).
Patients meeting the eligibility criteria will be offered the opportunity to have two additional blood tubes taken for research purposes, as part of an integrated visit to monitor HIV infection, which already includes a venipuncture. Patients meeting these criteria will have been previously identified by a feasibility survey carried out by the clinical research team of the Infectious and Tropical Diseases Department (SMIT) at Hôpital Bichat-Claude Bernard (AP-HP. Nord).
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.
PLHIV with persistent low plasma viral load on ARV therapy :
* PLHIV \> 18 years of age
* On ARV treatment for at least 3 years
* Taking one of the following ARV treatments:
* Tenofovir Alafenamide + Emtricitabine + Bictegravir
* Abacavir + Lamivudine + Dolutegravir
* Tenofovir Disoproxil Fumarate + Emtricitabine + Dolutegravir
* Tenofovir Disoproxil Fumarate + Lamivudine
\+ Doravirine
* Abacavir + Lamivudine + Doravirine
* With at least 3 consecutive HIV plasma viral loads between 50 and 1,000 copies/mL over a period of at least 12 months
* Absence of resistance mutations to current antiretroviral treatments
PLHIV group with perfect control of viral replication (stable virological suppression):
* PLWH \> 18 years of age
* On ARV treatment for at least 3 years
* Taking one of the following ARV treatments:
* Tenofovir Alafenamide + Emtricitabine + Bictegravir
* Abacavir + Lamivudine + Dolutegravir
* Tenofovir Disoproxil Fumarate + Emtricitabine + Dolutegravir
* Tenofovir Disoproxil Fumarate + Lamivudine
\+ Doravirine
* Abacavir + Lamivudine + Doravirine
* With at least 3 plasma HIV viral loads below 50 copies/mL over a period of at least 24 months
* Absence of resistance mutations to current antiretroviral treatments
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Quantification of HIV-1 cellular reservoir parameters using molecular techniques
Timeframe: At study inclusion (single blood sample)