Status:
COMPLETED
Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
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 st...
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,...
Eligibility Criteria
Inclusion
- Patients equal or older than 18 years old
- Chronic HIV infection
- HIV patients in whom LA CAB+RPV is prescribed
- Recommended triple or dual therapy for at least 12 months, including CAB+RPV LA.
- 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.
- 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.
- Patients which have access to an out of hospital center in which can be treated without inconvenience
- Patient who agrees to participate in the study and signs the informed consent.
Exclusion
- Hepatitis B infection (section 6.2).
- History of virological failure or mutations to INSTI or NNRTI.
- Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month.
- Contraindication for intramuscular injections
- Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future.
- Current use of any concomitant treatment as indicated in section 5.6.
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT06185452
Start Date
September 26 2023
End Date
May 30 2025
Last Update
July 14 2025
Active Locations (9)
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1
Germans Trias I Pujol Hospital
Badalona, BARCELONA, Spain, 08916
2
CAP Dr ROBERT
Barcelona, Barcelona, Spain, 08001
3
Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron
Barcelona, Barcelona, Spain, 08001
4
BCN CheckPoint
Barcelona, Barcelona, Spain, 08015