NCT05835635Not yet recruiting
Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
Level of Satisfaction and Quality of Life in People Living With HIV in Chile, Who Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
Source: ClinicalTrials.gov · Last updated 7 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This protocol will assess the level of satisfaction, acceptance of treatment and quality of life of patients with undetectable HIV who voluntarily change from oral to injectable antiretroviral treatment at 72 weeks of follow-up.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 24 Mar 2023
- Start date
- 1 May 2025
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Diseases
- HIV
- NCT number
- NCT05835635
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 May 2025 to the primary completion date, 1 Dec 2025
- 1 site 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
- These criteria are defined for those patients who, according to the recommendations for use, cannot receive the therapy:
- Previous virological failure
- Concomitant use with: rifampin, carbamazepine, oxcarbazepine, phenytoin and phenobarbital or any contraindication to one of the drugs of the study
Other illness
- Patients with decompensated pathology (physical or mental) or active opportunistic infection at the time of admission
- Known hepatitis B co-infection
Other
- Any evidence of primary resistance or the presence of any major known INI or NNRTI resistance-associated mutation by any historical resistance test result.
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CICUC Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.