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.

Phase 1

• Conditions: HIV-Infected patients; MedDRA version: 20.1Level: LLTClassification code: 10008922Term: Chronic infection with HIV Class: 10021881; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2023-503963-41-00
• Lead Sponsor: Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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 partner1) from 14 days prior to the first IMP administration until at least 13 months after the last IMP administration; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol., Patient who agrees to participate in the study and signs the informed consent., Patients which have access to an out of hospital center in which can be treated without inconvenience

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified