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

NCT ID: NCT06185452

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2025-05-30

Brief 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.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hospital Group

Administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg in the hospital (standard of care)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as standard of care.

Outpatient Group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Out of Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as an optional therapy in HIV-Infected patients from Spain.

Interventions

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

Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as standard of care.

Intervention Type: DRUG

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

Out of Hospital administration of long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg as an optional therapy in HIV-Infected patients from Spain.

Intervention Type: DRUG

Other Intervention Names

Administration of LA CAB+RPV in the hospital; Administration of LA CAB+RPV out of hospital

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Spain

References

Negredo E, Hernandez-Sanchez D, Alvarez-Lopez P, Falco V, Rivero A, Jusmet J, Cuerda Palomo MA, Flores de la Cruz AB, Pavon JM, Llavero N, Campany D, Faus V, Broto-Cortes C, Bailon L, Aguilar D, Ruiz F, Miranda C, Puig J, Rovira D, Olalla J. Exploring the acceptability, appropriateness, feasibility and satisfaction of an implementation strategy for out-of-HOspital administration of the Long-Acting combination of cabotegravir and rilpivirine as an optional therapy for HIV in Spain (the HOLA study)-a hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study: study protocol. BMJ Open. 2025 Apr 10;15(4):e088514. doi: 10.1136/bmjopen-2024-088514.

Reference Type: DERIVED

PMID: 40216420 (View on PubMed)

Other Identifiers

Out-of-hospital LA CAB+RPV

Identifier Type: -

Identifier Source: org_study_id