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.

Prior treatment

• 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.

Other illness

• Hepatitis B infection (section 6.2).
• History of virological failure or mutations to INSTI or NNRTI.

Other

• Contraindication for intramuscular injections
• Pregnancy or breastfeeding women, or with the desire to become pregnant in the near future.

• 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