Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy (SCohoLART)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Cumulative proportion of people with treatment failure
研究概览
简要总结
Systematic, continuative collection of clinical and laboratory data on patients followed at lnfectious Diseases Unit of the IRCCS San Raffaele Hospital in Milan, receiving long-acting ART (Phase IV, single-center, prospective, cohort study)
PRIMARY ENDOPOINT: Treatment failure over 48 weeks, defined as virological failure (VF) or therapy discontinuation for any reason (TD)
SECONDARY ENDPOINTS:
Clinical and pharmacological determinants of efficacy, tolerability, toxicity Modifications in risk and incidence of comorbidities Description of drug-resistance in case of VR Efficacy of rescue regimens in case of VF Quality of life and patient's satisfaction
详细描述
The SCohoLART Study consists of the systematic, continuative collection of clinical and laboratory data on patients followed at the Centro San Luigi (lnfectious Diseases) of the IRCCS Ospedale San Raffaele in Milano, receiving long-acting ART regimens.
Currently the Centro San Luigi follows-up·5122 HIV-infected patients; we hypothesize that at least one third of them (roughly 1500) could be initially eligible for a long-acting ART with cabotegravir and rilpivirine
The collection of study related clinical and laboratory information, as well as study specific blood samples, will start only after the patient has given and dated/signed his/her informed consent to participate in the study.
Patients enrolled in this cohort will be followed according to the standard of care; they will receive the prescribed long-acting regimen according to the indication and posology authorized by AIFA and described in the technical sheet of the drug(s). Follow-up ambulatory visits and laboratory tests will be generally performed every 6 months (earlier, if necessary, on patient's demand or physician's opinion). According to EACS guidelines, patients with obesity, metabolic syndrome or persistent ALT elevation will be evaluated for suspected non-alcoholic fatty liver disease (NAFLD) by ultrasonography and then by liver transient elastography (fibroscan), if NAFLD suggested by ultrasonography.
The following information will be checked and recorded at baseline:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •HIV infection;
- •Age > 18 years;
- •HIV-RNA <50 copies/ml;
- •Stable ART;
- •Planned start of a long-acting regimen approved by AIFA (initially, cabotegravir and rilpivirine);
- •Written informed consent provided.
排除标准
- •Any contraindication to the use of one or more long-acting drug, according to the technical sheet of the long-acting drug(s) planned to be started (including pregnancy, current or planned).
研究组 & 干预措施
HIV-positive people virologically suppressed without resistance/failure to NNRTI and INI
Initial administration of two separate intramuscolar injection of cabotegravir 400mg/3mL and rilpivirine 600mg/3mL in opposite gluteal muscles, repeated one month later and then every two months.
干预措施: Cabotegravir 600mg/3mL, Rilpivirine 900mg/3mL (Drug)
结局指标
主要结局
Cumulative proportion of people with treatment failure
时间窗: 48 weeks
The primary study endpoint will be the cumulative proportion of people with treatment failure over 48 weeks. Treatment failure is defined by the occurrence of virological failure (2 consecutive HIV-RNA values \>50 copies/mL or a single HIV-RNA value \>1000 copies/mL after the start of a long-acting ART with cabotegravir and rilpivirine) or discontinuation for any reason of the study regimen. The SCohoLART Study wants to collect clinical data on HIV-infected patients treated with long-acting regimens approved by AIFA (cabotegravir and rilpivirina), in order to optimize during a long-term follow-up their clinical management.
次要结局
- Incidence of new comorbidities(48 weeks)
- Cumulative proportion of people with experience of toxic effects(48 weeks)
- Creatinine (mg/dl) as values of risk comorbidities(48 weeks)
- Cumulative proportion of individuals with HIV-RNA <50 copies/mL at 1 and 2 years(48 weeks)
- Triglycerides (mg/dl) as values of risk comorbidities(48 weeks)
- Total cholesterol (mg/dl) as values of risk comorbidities(48 weeks)
- Proportion of individuals achieving virological success (HIV-RNA <50 copies/mL) with new ART regimens in case of virological failure(48 weeks)
- Glucose (mg/dl) as values of risk comorbidities(48 weeks)
- BMI (kg/m^2) as values of risk comorbidities(48 weeks)
- High density lipoprotein cholesterol (HDL, mg/dl) as values of risk comorbidities(48 weeks)
- Low density lipoprotein cholesterol (LDL, mg/dl) as values of risk comorbidities(48 weeks)
- Cumulative proportion and features of drug-resistance(48 weeks)
- w-bq12 questionnaire(48 weeks)
研究者
Castagna Antonella
Professor
IRCCS San Raffaele