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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.
EU CTIS ID: 2023-503963-41-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.