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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 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3346

Last updated 2026-07-14

No results posted yet for this study

Summary

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.

Conditions

  • Human Immunodeficiency Virus Infection (HIV)
  • HIV-1 Infection in Adults

Sponsors & Collaborators

  • Hospital Universitario de Burgos

    collaborator OTHER

  • FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2029-04-30
Completion
2029-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07703748 on ClinicalTrials.gov