A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV
NCT06518408 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 287
Last updated 2024-07-24
Summary
The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. This study also registers some immunological, metabolic,anti-inflammatory parameters and fat distribution analysis to observe a hypothetical improvement on these parameters.
Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffer certain psychological disorders. Patient experience data will be assessed through PROs and bespoke single-item questions to collect patient perception of treatment and register psychosocial aspects related to their health status.
Conditions
- Human Immunodeficiency Virus
Interventions
- DRUG
-
Cabotegravir Injectable Product
long-acting regimen dosed every 2-months
- DRUG
-
Rilpivirine Injectable Product
long-acting regimen dosed every 2-months
Sponsors & Collaborators
-
ViiV Healthcare
collaborator INDUSTRY -
University Hospital Virgen de las Nieves
lead OTHER
Principal Investigators
-
CARMEN HIDALGO, PhD · HU Virgen de las Nieves
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2026-04-30
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- Spain
Study Locations
More Related Trials
-
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
NCT06694805 ·Status: RECRUITING ·Phase: PHASE3
-
A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
NCT04399551 ·Status: COMPLETED ·Phase: PHASE3
-
Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
NCT06424964 ·Status: RECRUITING
-
Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.
NCT06643897 ·Status: COMPLETED ·Phase: NA
-
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
NCT05996471 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
NCT05660980 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
NCT06451341 ·Status: ACTIVE_NOT_RECRUITING
-
Clinical Effectiveness-Implementation Hybrid Type 2 Study on Home-Delivered Cabenuva for People Living With HIV Who Are Not Retained in Care
NCT06062979 ·Status: ENROLLING_BY_INVITATION
-
Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
NCT05835635 ·Status: NOT_YET_RECRUITING
-
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT05917509 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Effect of High Fat Meal on Cabotegravir
NCT02799264 ·Status: COMPLETED ·Phase: PHASE1
-
Satisfaction of HIV-infected Patients Treated With Cabotegravir-rilpivirine Injectable Dual Therapy
NCT05697289 ·Status: UNKNOWN
-
Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study
NCT03639311 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
NCT06411223 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset
NCT06834113 ·Status: RECRUITING ·Phase: NA
-
Phase I/II, Open-Label Trial of Three Monoclonal Antibodies
NCT00219986 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Administration of High Doses of Antiretroviral Drugs to Eliminate the Latent HIV-1 Reservoir
NCT06640192 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Safety of the HIV-1 Vaccine MVA-B in Chronic HIV-1 Infected Patients Successfully Treated With HAART
NCT01571466 ·Status: COMPLETED ·Phase: PHASE1
-
Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial
NCT06485154 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community
NCT06704204 ·Status: NOT_YET_RECRUITING
-
Open-Label Multi-Centre Randomised Switch Study to Evaluate Virological Efficacy Over 96Weeks Of 2-Drug Therapy With Dolutegravir(DTG)/Rilpivirine(RPV) Fixed Dose Combination(FDC) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTI Mutation K103N
NCT05349838 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load
NCT05898841 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA
NCT05601128 ·Status: COMPLETED ·Phase: PHASE3
-
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
NCT00257621 ·Status: COMPLETED ·Phase: PHASE2
-
CAbotégravir LENacapavir DUal Long Acting
NCT06657885 ·Status: WITHDRAWN ·Phase: PHASE2