Overview

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

Status:
Active, not recruiting
Trial end date:
2025-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Treatments:
Cabotegravir
Rilpivirine
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).

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.