NCT06518408进行中（未招募）不适用
A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV
University Hospital Virgen de las Nieves15 个研究点 分布在 1 个国家目标入组 287 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 287
- 试验地点
- 15
- 主要终点
- Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 12
研究概览
简要总结
The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. This study also registers some immunological, metabolic,anti-inflammatory parameters and fat distribution analysis to observe a hypothetical improvement on these parameters.
Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffer certain psychological disorders. Patient experience data will be assessed through PROs and bespoke single-item questions to collect patient perception of treatment and register psychosocial aspects related to their health status.
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
- •participants are required to meet all the following inclusion criteria to be eligible for PWH.
- •Aged 18 years or older at the time of signing the informed consent.
- •Virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen
- •Documented evidence of plasma HIV-1 RNA measurements <50 copies/mL in the 6 months prior to Screening (1x blip is allowed).
- •Ability to understand informed consent form (ICF) and other relevant regulatory documents.
- •Prior to starting CAB LA + RPV LA injections, HIV physicians should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.
- •A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine hCG test ) and not lactating. Females of childbearing potential will be required to use a highly effective method of contraception.
排除标准
- •participants will be excluded from the trial if there is evidence of any of the following criteria at screening or check-in, as appropriate.
- •Within 6 months prior to Screening, any plasma HIV-1 RNA measurement ≥50 copies/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 copies/mL, or 2 or more plasma HIV-1 RNA measurements ≥50 copies/mL.
- •Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
- •Present or past evidence of viral resistance to agents of the NNRTI or INI class or prior treatment failure with agents of NNRTI or INSTI class
- •Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC).
- •Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
- •Participants positive for HBsAg are excluded.
- •Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded.
- •Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
- •Participants treated with entecavir are not excluded.
- •Any condition that does not recommend intramuscular injections in the gluteal muscle.
- •Pregnancy or breastfeeding women, or with the desire to become pregnant soon.
- •Current use of concomitant treatment with prohibited medication
研究组 & 干预措施
study group
Patients enrolled who switch to receive Cabotegravir long acting plus Rilpivirine long acting intramuscular injection every 2 months
干预措施: Cabotegravir Injectable Product (Drug)
study group
Patients enrolled who switch to receive Cabotegravir long acting plus Rilpivirine long acting intramuscular injection every 2 months
干预措施: Rilpivirine Injectable Product (Drug)
结局指标
主要结局
Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 12
时间窗: 12 months
Proportion of participants suppressed on stable oral ART that switched to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12
次要结局
- Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at months 12 and 24(12 and 24 months)
- Description of reasons for discontinuation from CAB LA + RPV LA over 24 months(24 months)
- Changes in absolute values from baseline over 24 months in metabolic control parameters: lipids(24 months)
- Changes in absolute values from baseline over 24 months in metabolic control parameters: weight(24 months)
- Changes in absolute values from baseline over 24 months in metabolic control parameters: BMI(24 months)
- Changes in pro-inflammatory biomarkers (D-Dimmer) from baseline over 24 months in a subgroup of participants(24 months)
- Number of participants experiencing confirmed virologic failure at months 12 and 24.(12 and 24 months)
- Change from baseline in the mean lymphocyte subpopulations(12 and 24 months)
- Changes in absolute values from baseline over 24 months in metabolic control parameters: glucose(24 months)
- Changes in pro-inflammatory biomarkers (CRP) from baseline over 24 months in a subgroup of participants(24 months)
- Incidence and severity of adverse events(24 months)
- Changes in absolute values from baseline over 24 months in metabolic control parameters: waist circumference.(24 months)
- Changes in hepatic values (Alanine transaminase (ALT), Aspartate transaminase (AST) and Alkaline phosphatase (ALP)) from baseline over 24 months(24 months)
- Description of reasons for switching to CAB LA + RPV LA(24 months)
- Changes in pro-inflammatory biomarkers (fibrinogen) from baseline over 24 months in a subgroup of participants(24 months)
- Changes in creatinine values from baseline over 24 months(24 months)
- Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 24(24 months)
- Number of episodes of plasma HIV-1 RNA ≥50 copies/mL(24 months)
- Number of reports fo adverse events over 24 months(24 months)
- Changes in patient reported outcomes questionnaires from baseline over 24 months: WHOQOL-HIV-BREF(24 months)
- Changes in patient reported outcomes questionnaires from baseline over 24 months: HSSS(24 months)
- Changes in patient reported outcomes questionnaires from baseline over 24 months: PSQI(24 months)
- Changes in pro-inflammatory biomarkers (IL-6) from baseline over 24 months in a subgroup of participants(24 months)
- Changes in preference values from baseline over 24 months about ART(12 and 24 months)
- Changes in hepatic values (Albumine) from baseline over 24 months(24 months)
- Incidence of adherence to scheduled interventions over 24 months(24 months)
研究者
Carmen Hidalgo Tenorio
Professor
University Hospital Virgen de las Nieves
研究点 (15)
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