2024-516028-33-01招募中3 期
(CAbotégravir LENacapavir DUal Long Acting). Phase II, Pilot study, open label, multicenter, evaluating dual antiretroviral therapy with long-acting cabotegravir/lenacapavir IMEA 069 - CALENDULA
Inst Medecine Epidemiologie Appliquee12 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 12
- 主要终点
- Percentage of participants with virological failure at week 48: i.2 consecutive CVs ≥50 copies/mL after achieving a CV <50 copies/mL; or ii. a CV ≥50 copies/mL followed by definitive cessation of treatment or follow-up after achieving a CV <50 copies/mL; or iii. a viral load CV ≥50 copies/mL at week 48. For patients detectable at baseline, virological failure will be assessed from week 24.
研究概览
简要总结
To evaluate the efficacy of maintenance dual antiretroviral therapy with cabotegravir/lenacapavir over 48 weeks of follow-up. Efficacy being defined by the absence of virological failure: 2 successive CVs ≥50 copies/mL or a CV ≥50 copies/mL followed by definitive cessation of treatment or follow-up, or a CV ≥50 copies/mL at W48)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •For women at risk of pregnancy, commitment to use an effective method of contraception for the duration of the study.
- •Affiliated or beneficiary of a social security scheme (article L1121-11 of the French Public Health Code),
- •Free, informed, written consent, signed by the person and the investigator no later than the day of inclusion and before any examination carried out as part of the study
- •HIV-1 infection
- •Stable oral antiretroviral treatment for at least 6 months
- •Multi-treated patients who have received multiple lines of antiretroviral treatment - Undetectable patients with CV < 50 copies/mL in the last 6 months (a single blip between 50 and 200 copies/mL in the last 6 months is allowed) and eligible to switch to the lenacapavir/cabotegravir strategy on the basis of a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to - the presence of resistance mutations, including to NNRTIs - or oral drug intolerance - or drug-drug interactions - Detectable, virologically uncontrolled HIV viral load ≥ 200 c/mL in the last 12 months who is eligible to switch to the lenacapavir/cabotegravir strategy based on a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to - the presence of resistance mutations, including to NNRTIs - or oral drug intolerance - or drug-drug interactions
- •ASAT and ALAT < 3N
- •Creatinine Clearance> 60 mL/min (CKD-EPI)
- •Haemoglobin > 10 g/dL
- •Platelets > 100 000/mm3
- •Commitment to use preventive and protective means of sexual intercourse for the duration of the trial
排除标准
- •HIV-2 infection or HIV-1/HIV2 co-infection
- •Taking medication contraindicated with the trial treatment
- •Major incapacity, legal protection, guardianship or curatorship
- •Project to move in a non-study site within the next 18 months
- •HIV-1 subtype A6/A1
- •BMI ≥ 30kg/m².
- •Chronic active viral hepatitis B with positive Hbs antigen
- •Active chronic viral hepatitis C requiring specific treatment over the next 48 weeks.
- •Treatment with interferon, interleukin or any other immunotherapy or chemotherapy in progress.
- •Active opportunistic infection, or acute treatment for opportunistic infection
- •Any condition (alcohol, drugs, neurological or neuropsychiatric disorders, etc.) likely to compromise tolerance of treatment and/or patient compliance with treatment and adherence to the protocol, as judged by the investigator.
- •Women who are breastfeeding, pregnant or refusing contraception
结局指标
主要结局
Percentage of participants with virological failure at week 48: i.2 consecutive CVs ≥50 copies/mL after achieving a CV <50 copies/mL; or ii. a CV ≥50 copies/mL followed by definitive cessation of treatment or follow-up after achieving a CV <50 copies/mL; or iii. a viral load CV ≥50 copies/mL at week 48. For patients detectable at baseline, virological failure will be assessed from week 24.
Percentage of participants with virological failure at week 48: i.2 consecutive CVs ≥50 copies/mL after achieving a CV <50 copies/mL; or ii. a CV ≥50 copies/mL followed by definitive cessation of treatment or follow-up after achieving a CV <50 copies/mL; or iii. a viral load CV ≥50 copies/mL at week 48. For patients detectable at baseline, virological failure will be assessed from week 24.
次要结局
- Metabolic parameters (total cholesterol, LDL-c, HDL-c, triglycerides and fasting plasma glucose) from D0 to W48
- Percentage of participants with virological failure between W24 and W48
- Percentage of participants achieving therapeutic success at W48 (absence of virological failure and definitive discontinuation of assigned treatment or study continuation due to intolerance). Change of residence, change of treatment due to pregnancy, force majeure (inability to give an injection due to hospitalisation or travel abroad, etc.) and death unrelated to study treatment will not be considered as failures.
- Percentage of participants with viruses harbouring resistance mutations to the current treatment at the time of virological failure (by Sanger) and description of the resistance mutations selected at the time of virological failure.
- Proportion of minority resistance variants archived in DNA at D0 and their impact on the risk of virological failure and on the selection of resistance mutations.
- Describe the evolution of the proportion of intact and defective proviruses in PBMC at D0 and W48.
- Percentage of participants with at least one "blip" (viral load greater than 50 copies/mL with a control less than or equal to 50 copies/mL) between D0 and W48.
- Change in CD4 and CD8 T lymphocytes and CD4/CD8 ratio between W-2 and W48
- Description of plasma concentrations of antiretroviral treatments between D0 and W48
- Incidence of clinical and laboratory grade 3 or higher adverse events
- Incidence of adverse events and discontinuation from study to W48
- Changes in weight and BMI from D0 to W48
- Change in participants' symptoms as assessed by self-report questionnaire from D0 to W48
- Assessment of participant satisfaction by questionnaire between D0 and W48
研究者
ROLAND LANDMAN
Scientific
Inst Medecine Epidemiologie Appliquee
研究点 (12)
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