Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intervention Appropriateness Measure (IAM) scale
研究概览
简要总结
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients.
Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.
详细描述
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study. This means that the study will focus both on implementation and effectiveness by examination of two different settings of treatment administration (hospital-based and home-based) to identify what facilitators or barriers may improve feasibility (i.e. factors that can either help or hinder the successful implementation), appropriateness and acceptability of each strategy delivery mode in order to address the needs of PLWH followed in a large clinical center in Milan, Italy.
The study will use an implementation science approach to address the question of 'what works, where and why' by identifying factors and processes that negatively and positively affect implementation outcomes from both the patients and providers perspective.
Real-world efforts to delivering the treatment to HIV-1-infected, virologically suppressed adults in two different settings (home or hospital) will be sustained.
Two healthcare delivery pathways will be explored in this study:
- Hospital-based setting: HIV clinic nurse will administer injections at the clinic;
- Home-patient setting: HIV clinic nurse will administer injections at patient home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV;
- •Aged 18 years or older at the time of signing the informed consent.
- •People willing to switch to long-acting therapy
- •on a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA <50 copies/ml):
- •Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6 months prior to Screening.
- •Plasma HIV-1 RNA <50 c/mL at Screening.
- •Ability to understand informed consent form and other relevant regulatory documents.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
- •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
- •Unwillingness or any condition that might prevent the completion of all surveys over study follow-up.
- •Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC):
- •Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
- •Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/mL are not exclusionary
- •Participants with moderate to severe hepatic impairment
- •Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
- •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.
- •Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Clinicians must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded
- •Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis (eg. ascites, encephalopathy, or variceal bleeding)), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
- •History of liver cirrhosis with or without hepatitis viral co-infection.
- •Ongoing or clinically relevant pancreatitis
- •Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical and anal intraepithelial neoplasia.
- •History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
- •Current platelet count<100,000 x109/L.
- •Any evidence of primary resistance based on the presence of any major known Integrase inhibitor (INI) or Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation, except for K103N by any historical resistance test result.
- •Any verified Grade 4 laboratory abnormality at screening.
- •Subjects has estimated creatinine clearance <50mL/minute per 1.73-meter square via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method
- •Alanine aminotransferase (ALT) >=3 × Upper limit of normal (ULN)
- •Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- •Use of medications which are associated with Torsade de Pointes.
研究组 & 干预措施
Hospital arm
CAB 600mg +RPV 900mg q2M IM administration and follow-up in hospital
干预措施: Surveys completion (Other)
Hospital arm
CAB 600mg +RPV 900mg q2M IM administration and follow-up in hospital
干预措施: Hospital administration of CAB+RPV (Drug)
Home arm
CAB 600mg +RPV 900mg q2M IM administration and follow-up at home
干预措施: Surveys completion (Other)
Home arm
CAB 600mg +RPV 900mg q2M IM administration and follow-up at home
干预措施: Home administration of CAB+RPV (Drug)
结局指标
主要结局
Intervention Appropriateness Measure (IAM) scale
时间窗: Months 1 and 7 and 11
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Intervention Appropriateness Measure (IAM) and average composite score.
Qualitative insights
时间窗: Months 1 and 7 and 11
Qualitative insights regarding feasibility, acceptability, and appropriateness of CAB+RPV IM q2M.
Feasibility of Implementation Measure (FIM) scale
时间窗: Months 1 and 7 and 11
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Feasibility of Implementation Measure (FIM) and average composite score.
Acceptability of Intervention Measure (AIM) scale
时间窗: Months 1 and 7 and 11
Proportion of participants receiving injections with an average composite score greater than or equal to 4 across the questions of Acceptability of Intervention Measure (AIM) and average composite score.
次要结局
- Proportion of patients voluntary asking to stop CAB+RPV LA administration(Months 7 and 11)
- Proportion of patients willing to enroll in the study(Months 7 and 11)
- Adverse Events and Serious AEs(Months 7 and 11)
- EQ-5D-5L questionnaire(Months 1 and 7 and 11)
- Proportion of CAB+RPV LA injections occurring within the target window(Months 7 and 11)
- Average score of satisfaction on a Likert scale(Months 7 and 11)
- Proportion of PWH with HIV-RNA >50 copies/mL(Months 7 and 11)
- Time (months) to LA discontinuation(Months 7 and 11)
- HIV/AIDS-Targeted Quality of Life (HAT-QoL) questionnaire(Months 1 and 7 and 11)
- HIV Treatment Satisfaction Questionnaire (HIVTSQ)(Months 1 and 7 and 11)
研究者
Castagna Antonella
Prof
IRCCS San Raffaele