NCT07015164Not yet recruiting
Role of Viral Reservoir, Immune Activation and Depletion in Persistent Viremia Persistent Viremia in People Living With HIV on Antiretroviral Therapy
Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 10 Jun 2025
- Primary completion date
- 10 Sept 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- HIV
- NCT number
- NCT07015164
What you commit to
- Study type: Observational
- Planned participants: 80
- From 10 Jun 2025 to the primary completion date, 10 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Bichat, service des Maladies Infectieuses et Tropicales Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.