Loading clinical trials...

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

Implementation of Out-of-HOspital Administration of the Long-Acting Combination Cabotegravir+Rilpivirine as an Optional Therapy in HIV-Infected Patients From Spain: Acceptability, Appropriateness, Feasibility and Satisfaction: The HOLA Study

NCT06185452•Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

View on ClinicalTrials.gov

Summary

HOLA is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase IV, double arm, open label, multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CAB+RPV, to evaluate the out-of-hospital administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.

Detailed Description

Randomized patients will receive Long Acting (LA) cabotegravir (CAB) + rilpivirine (RPV) administration in the hospital (standard of care) or out-of-hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits, routinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients equal or older than 18 years old
•2. Chronic HIV infection
•3. HIV patients in whom LA CAB+RPV is prescribed
•4. Recommended triple or dual therapy for at least 12 months, including CAB+RPV LA.
•5. Virologically suppression for at least 6 months: 2 consecutive determinations of undetectable viral load (plasma HIV-1 RNA levels \< 50 copies/ml ) for ≥ 6 months preceding the study randomization.
•6. Post-menopausal or fertile females that agree to avoid pregnancy during the study. If sexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner) from 14 days prior to the first IMP administration until at least 13 months after the last Investigational Medicinal Product (IMP) administration;all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol.
•7. Patients which have access to an out of hospital center in which can be treated without inconvenience
•8. Patient who agrees to participate in the study and signs the informed consent.

Exclusion Criteria

•1. Hepatitis B infection (section 6.2).
•2. History of virological failure or mutations to INSTI or NNRTI.
•3. Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
•4. Contraindication for intramuscular injections
•5. Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future.
•6. Current use of any concomitant treatment as indicated in section 5.6.

Locations (9)

Germans Trias I Pujol Hospital

Badalona, BARCELONA, Spain

CAP Dr ROBERT

Barcelona, Barcelona, Spain

Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron

Barcelona, Barcelona, Spain

BCN CheckPoint

Barcelona, Barcelona, Spain

Hospital Vall D' Hebrón

Barcelona, Barcelona, Spain

Hospital Costa Del Sol

Málaga, Malaga, Spain

Cs Leganitos

Málaga, Málaga, Spain

Cs San Pedro de Alcántara

Málaga, Málaga, Spain

Cs San Luis de Sabinillas

San Luis de Sabinillas, Málaga, Spain

Key Dates

Start Date

September 26, 2023

Primary Completion Date

May 30, 2025

Completion Date

May 30, 2025

Last Updated

July 14, 2025

Enrollment

103

ACTUAL participants

Conditions

HIV-1 Infection

Interventions

Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration

DRUG

Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration

DRUG

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

NCT06602622

HIVHIV Associate Weight Loss+4 more

View study

NOT_YET_RECRUITINGNA

Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS

NCT06902038

HIV-1 Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS

Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)

Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients

Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)