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Long-Term Real-World Evidence Study to Evaluate Effectiveness, Persistence, Adherence, Safety and Tolerability of Long-acting Cabotegravir Plus Rilpivirine.

NCT07703748

Active Not RecruitingN/A

Sponsor: FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE

Conditions: Human Immunodeficiency Virus Infection (HIV), HIV-1 Infection in Adults

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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, 2025.
* Able to understand and provide written informed consent.

Exclusion Criteria:

* 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.

Locations (1)

Burgos, Spain