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.
Key facts
- Where
- Badalona, Barcelona, Marbella, San Luis de Sabinillas és San Pedro de Alcántara, SpanyolországSee the 9 sites
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- CAP Doctor RobertBadalona, SpanyolországNo longer taking part
- Hospital Universitari Germans Trias i PujolBadalona, SpanyolországNo longer taking part
- BCN CheckpointBarcelona, SpanyolországNo longer taking part
- Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Centro de Salud LeganitosMarbella, SpanyolországNo longer taking part
- Hospital Costa del SolMarbella, SpanyolországNo longer taking part
- Centro de Salud San Luis de SabinillasSan Luis de Sabinillas, SpanyolországNo longer taking part
- Centro de Salud San Pedro de AlcántaraSan Pedro de Alcántara, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
- Trial code
- EU 2023-503963-41-00
- Record updated
- 2024. június 7.
- Original description
The study will evaluate: 1. the acceptability at month 12 of the administration of LA CAB + RPV in AOF from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections. 2. will also assess and compare the safety and tolerability of the LA CAB+RPV.Read full original descriptionShow less
The study will evaluate: 1. the acceptability at month 12 of the administration of LA CAB + RPV in AOF from the perspective of participants receiving outside-hospital injections vs the participants receiving hospital injections. 2. will also assess and compare the safety and tolerability of the LA CAB+RPV.
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 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: Previous antiretroviral treatment interruption during the last 6 months or treatment interruptions for more than a month; Current use of any concomitant treatment as indicated in section 5.6; Hepatitis B infection (section 6.2); History of virological failure or mutations to INSTI or NNRTI; Contraindication for intramuscular injections; Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future.