RETROSPECTIVE AND PROSPECTIVE MULTICENTER STUDY EVALUATING LONG TERM EFFECTIVENESS AND SAFETY OF CABOTEGRAVIR AND RILPIVIRINE IN REAL LIFE AS A LONG-ACTING TREATMENT IN PEOPLE LIVING WITH HIV AFTER ITS IMPLEMENTATION IN SPAIN. RELATIVITY COHORT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,346
- 试验地点
- 1
- 主要终点
- Proportion of participants with HIV-1 RNA ≥50 copies/mL
研究概览
简要总结
The RELATIVITY study is a nationwide, multicenter, ambispective observational cohort evaluating the long-term effectiveness, safety, persistence, and tolerability of long-acting injectable cabotegravir plus rilpivirine (CAB+RPV LA) in people living with HIV in Spain.
The study includes adults with HIV-1 infection who achieved virological suppression on oral antiretroviral therapy and switched to long-acting CAB+RPV as part of routine clinical care. No study-specific treatment or interventions are performed. Clinical information is collected retrospectively from treatment initiation and prospectively during routine follow-up.
The primary objectives are to evaluate long-term virological effectiveness, treatment persistence, and confirmed virological failure over five years. Secondary objectives include assessment of safety, treatment discontinuation, adherence to injection schedules, immunological outcomes, metabolic changes, patient-reported outcomes, and factors associated with treatment success or failure. The study also evaluates outcomes in clinically relevant subgroups, including older adults, women, migrants, people with obesity, individuals with multimorbidity, and those infected through vertical transmission.
详细描述
The RELATIVITY cohort is a national, multicenter, ambispective, non-interventional observational study designed to evaluate the long-term real-world effectiveness, safety, persistence, adherence, and tolerability of long-acting injectable cabotegravir plus rilpivirine (CAB+RPV LA) following its implementation into routine HIV care in Spain.
The study includes adults with HIV-1 infection who were virologically suppressed on oral antiretroviral therapy and switched to CAB+RPV LA according to routine clinical practice and approved prescribing information. Treatment decisions are entirely independent of study participation. No investigational intervention, randomization, or protocol-mandated treatment procedures are performed.
Participants receiving at least one injection of CAB+RPV LA between January 2023 and December 2024 are included through retrospective data collection, followed by prospective observation for up to five years after treatment initiation. Clinical data are collected from electronic medical records and entered into a centralized electronic case report form (eCRF). Follow-up reflects routine clinical practice at each participating center.
The primary study objectives are to evaluate:
Long-term maintenance of virological suppression. Treatment persistence. Time to confirmed virological failure.
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
- •Adults aged ≥18 years.
- •Documented HIV-1 infection.
- •Receiving oral antiretroviral therapy with plasma HIV-1 RNA <50 copies/mL at the time of switching to long-acting cabotegravir plus rilpivirine (CAB+RPV LA).
- •No current or previous evidence of resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase strand transfer inhibitors (INSTIs), and no previous virological failure with these drug classes.
- •Received at least one injection of CAB+RPV LA before January 1,
- •Able to understand and provide written informed consent.
排除标准
- •Any contraindication to CAB+RPV LA according to the approved product labeling.
- •Previous exposure to long-acting CAB+RPV within an interventional clinical trial.
- •Active hepatitis B infection (HBsAg positive).
- •Pregnancy or breastfeeding.
研究组 & 干预措施
RELATIVITY
Adults living with HIV-1 who achieved virological suppression on oral antiretroviral therapy and switched to long-acting intramuscular cabotegravir plus rilpivirine (CAB+RPV LA), administered every two months according to routine clinical practice and approved prescribing information in Spain. Participants are enrolled in a nationwide multicenter ambispective observational cohort and followed longitudinally to evaluate long-term effectiveness, treatment persistence, safety, adherence, tolerability, and virological outcomes. No study-specific intervention or treatment allocation is performed.
结局指标
主要结局
Proportion of participants with HIV-1 RNA ≥50 copies/mL
时间窗: Month 12, Month 24, Month 36, Month 48, and Month 60
Proportion of participants with plasma HIV-1 RNA ≥50 copies/mL after initiation of long-acting cabotegravir plus rilpivirine, assessed according to the FDA Snapshot algorithm.
次要结局
- Treatment persistence with CAB+RPV LA(From baseline to Month 60)
研究者
Jesus Troya
MD, PHD
FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE