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NCT06185452CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 14 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
103 (actual)
First submitted
22 Sept 2023
Start date
Sept 2023
Primary completion date
May 2025
Lead sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Diseases
HIV
NCT number
NCT06185452

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 103
  • From Sept 2023 to the primary completion date, May 2025
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Germans Trias I Pujol Hospital
Coordinator of this site? Confirm its status
BadalonaSpainUnknown status
Hospital Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
BCN Checkpoint
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Centre de Salut Internacional i Malalties Transmissibles Drassanes - Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
CAP Dr ROBERT
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Cs Leganitos
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Hospital Costa del Sol
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Cs San Pedro de Alcántara
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Cs San Luis de Sabinillas
Coordinator of this site? Confirm its status
San Luis de SabinillasSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.