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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 13
- 主要终点
- Percentage of participants with virological failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants' objection to the use of follow-up data
结局指标
主要结局
Percentage of participants with virological failure
时间窗: Week 48
Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL \<50 copies/mL
Percentage of participants with virological failure
时间窗: Week 24
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
Percentage of participants with virological failure
时间窗: Week48
A VL ≥50 copies/mL
次要结局
- 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.(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(From the enrollment to the end of treatment at week 48)