Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT05835635
Eligibility Criteria:
Inclusion Criteria:
All patients who, according to the recommendations for use, can receive LA- injectable Cabotegravir +Rilpivirine therapy will be invited to participate in the study.
Recommendations for use:
* HIV-1 positive patients, on antiretroviral therapy
* Older than 18 years of age at the time of signing the informed consent
* Undetectable HIV viral load in the last 6 months
* Willing to switch from oral to injectable therapy
Exclusion Criteria:
These criteria are defined for those patients who, according to the recommendations for use, cannot receive the therapy:
* Previous virological failure
* Any evidence of primary resistance or the presence of any major known INI or NNRTI resistance-associated mutation by any historical resistance test result.
* Patients with decompensated pathology (physical or mental) or active opportunistic infection at the time of admission
* Concomitant use with: rifampin, carbamazepine, oxcarbazepine, phenytoin and phenobarbital or any contraindication to one of the drugs of the study
* Known hepatitis B co-infection
* Pregnancy (There is insufficient data for people who become pregnant on CAB or those planning to conceive because available pregnancy PK data are limited (n = 3), and data on clinical outcomes in pregnancy are extremely limited. Therefore, CAB is Not Recommended for pregnant or nonpregnant people initiating or restarting ART or for those whose current regimen is not well tolerated and/or not fully suppressive)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05835635
Study Brief:
Protocol Section:
NCT05835635