CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: CABOTEGRAVIR, LENACAPAVIR. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
CAbotégravir LENacapavir DUal Long Acting). Immuno-virological Monitoring and Safety Assessment of HIV-1 Infected Patients Receiving a Long-Acting Antiretroviral Combination of Cabotegravir and Lenacapavir
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Percentage of participants with virological failure [Срок оценки: Week 48]
- Percentage of participants with virological failure [Срок оценки: Week 24]
- Percentage of participants with virological failure [Срок оценки: Week48]
Вторичные конечные точки (8)
- 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). [Срок оценки: Week48]
- 2. Percentage of participants with viruses showing resistance-associated mutations. [Срок оценки: Week 48]
- 3. Percentage of participants experiencing at least one "blip" [Срок оценки: from Week 24 to week 48]
- 4. Plasma concentrations of antiretroviral drugs [Срок оценки: from Week 24 to week 48]
- 5. Changes in CD4 and CD8 T-cell counts and in the CD4/CD8 ratio [Срок оценки: from enrollment to the end of treatment at 48 weeks]
- 6. Incidence of adverse events and biological abnormalities [Срок оценки: from enrollment to the end of the treatment at week 48]
- 7. Changes in body weight and BMI [Срок оценки: from the enrollment to the end the treatment at week 48]
- 8. Changes in metabolic parameters [Срок оценки: From the enrollment to the end of treatment at week 48]
Критерии участия
- Age ≥18 years
- HIV-1 infection
- Patients who started taking cabotegravir combined with lenacapavir between July 2024 and the one-year follow-up, or who are due to start taking the CAB/LEN combination.
- Patients who are due to start the CAB/LEN combination following a medical decision.
Критерии исключения
- Participants' objection to the use of follow-up data
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 13 центров
- Victor Dupuy Hospital — Argenteuil
- Pellegrin Hospital — Bordeaux
- Saint André Hospital — Bordeaux
- Raymond poincaré Hospital — Garches
- Franco-British Hospital (Fbh) — Levallois-Perret
- Hotel Dieu Hospital — Nantes
- Archet 1Hospital — Nice
- Bichat Claude Bernard Hospital — Paris
- … и ещё 5 центров
Идентификаторы
NCT: NCT07402044 · 2025-A02118-41 · IDRCB