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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | National Agency for Medicines and Health Products Safety. |
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| Name | Class |
|---|---|
| INSERM UMR S 1136 | OTHER |
| ANRS, Emerging Infectious Diseases | OTHER_GOV |
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The main objective of this national study is to evaluate the virological success of long-acting antiretroviral therapy combining cabotegravir and lenacapavir. The study involves patients who have been receiving this treatment for one year or those for whom the physician decides to initiate it. It also aims to evaluate the tolerability of the treatment and changes in the participants' immunovirological profile during follow-up.
The CALENDULA cohort is a French multicenter study of people living with HIV (PLHIV) receiving long-acting dual therapy combining cabotegravir and lenacapavir (CAB/LEN) for at least 48 weeks.
The study has two parts:
Retrospective part: includes patients who started treatment between July 2024 and the date of the last available follow-up.
Prospective part: includes patients for whom the decision to initiate treatment is made during a 12-month recruitment period, with 48 weeks of follow-up.
No specific intervention is planned; data are simply collected from medical records.
Information will be collected at the following times after the start of treatment:
D0, W24, and W48.
The primary objective is to describe the virological response and tolerance of CAB/LEN dual therapy over 48 weeks.
Virological success is defined as maintaining a viral load (VL) < 50 copies/mL or suppression of VL at W48 without interruption of treatment.
The efficacy criterion is the virological failure rate at S48. The study aims to evaluate the feasibility and tolerability of this innovative therapeutic combination in order to prepare for a future larger-scale study on cabotegravir/lenacapavir.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with virological failure | Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL <50 copies/mL | Week 48 |
| Percentage of participants with virological failure | ii. A single VL ≥50 copies/mL followed by permanent treatment discontinuation or loss to follow-up after previously achieving VL <50 copies/mL; or discontinuation with VL ≥50 copies/mL | Week 24 |
| Percentage of participants with virological failure | A VL ≥50 copies/mL | Week48 |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Percentage of participants with therapeutic success using the FDA Snapshot approach (defined as absence of virological failure, permanent treatment discontinuation, or loss to follow-up). | Week48 | |
| 2. Percentage of participants with viruses showing resistance-associated mutations. |
| Measure | Description | Time Frame |
|---|---|---|
| 3. Percentage of participants experiencing at least one "blip | Week 24 | |
| Percentage of participants experiencing at least one "blip | Week 48 |
Exclusion Criteria:
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people living with HIV (PLHIV) in France, receiving long-acting dual therapy with cabotegravir/lenacapavir for at least 48 weeks, comprising: (i) a retrospective component, including patients who started this treatment from July 2024 until the last available follow-up data collection; (ii) a prospective component, including patients for whom a medical decision to initiate this treatment is made during a 12-month recruitment period, with a planned follow-up of 48 weeks.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roland LANDMAN | Contact | 1 40 25 63 65 | 33 | landman.roland@gmail.com |
| Aïda BENALYCHERIF | Contact | 1 40 25 63 65 | +33 | aida.benalycherif@fondation-imea.org |
| Name | Affiliation | Role |
|---|---|---|
| Roland LANDMAN | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victor Dupuy Hospital | Argenteuil | France |
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| Week 48 |
| 3. Percentage of participants experiencing at least one "blip" | from Week 24 to week 48 |
| 4. Plasma concentrations of antiretroviral drugs | from Week 24 to week 48 |
| 5. Changes in CD4 and CD8 T-cell counts and in the CD4/CD8 ratio | from enrollment to the end of treatment at 48 weeks |
| 6. Incidence of adverse events and biological abnormalities | from enrollment to the end of the treatment at week 48 |
| 7. Changes in body weight and BMI | from the enrollment to the end the treatment at week 48 |
| 8. Changes in metabolic parameters | changes in Total cholesterol, HDL, LDL, Triglycerid, Glyceamia levels | From the enrollment to the end of treatment at week 48 |
| Pellegrin Hospital | Bordeaux | France |
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| Saint André Hospital | Bordeaux | France |
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| Raymond poincaré Hospital | Garches | France |
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| Franco-British Hospital (Fbh) | Levallois-Perret | France |
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| Hotel Dieu Hospital | Nantes | France |
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| Archet 1Hospital | Nice | France |
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| Bichat Claude Bernard Hospital | Paris | France |
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| Hotel Dieu Hospital | Paris | France |
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| Necker Hospital | Paris | France |
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| Pitié Salpêtrière Hospital | Paris | France |
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| Saint Antoine Hospital | Paris | France |
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| Tourcoing Hospital | Tourcoing | France |
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