NCT07703748Active, not recruiting
Long-Term Real-World Evidence Study to Evaluate Effectiveness, Persistence, Adherence, Safety and Tolerability of Long-acting Cabotegravir Plus Rilpivirine.
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
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 3346 (actual)
- First submitted
- 9 Jul 2026
- Start date
- 31 Dec 2024
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- FUNDACIÓN HOSPITAL UNIVERSITARIO INFANTA LEONOR Y DEL HOSPITAL UNIVERSITARIO DEL SURESTE
- Diseases
- HIV
- NCT number
- NCT07703748
What you commit to
- Study type: Observational
- Participants enrolled: 3346
- From 31 Dec 2024 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to long-acting CAB+RPV within an interventional clinical trial.
Other illness
- Active hepatitis B infection (HBsAg positive).
Other
- Any contraindication to CAB+RPV LA according to the approved product labeling.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.