Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+rilpivirine (HOLA)

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

Status and phase: Active, not recruiting; Phase 4

Conditions: HIV-1 Infection

Treatments: Drug: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06185452

Out-of-hospital LA CAB+RPV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Hospital Group

Active Comparator group

Description:

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

Treatment:

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

Outpatient Group

Experimental group

Description:

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

Treatment:

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