Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine

Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Apr 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how satisfied patients with undetectable HIV are when they switch from taking oral medications to receiving long-acting injections of Cabotegravir and Rilpivirine. The study will follow participants for 72 weeks to see how this change affects their quality of life and how much they accept the new treatment option.

To join the study, patients must be over 18 years old, be HIV-positive and currently on treatment, and have an undetectable viral load in the last six months. They should also be willing to switch to the injectable therapy. However, some patients may not be eligible, such as those who have experienced treatment failure or have certain health conditions. If you decide to participate, you can expect to share your experiences with the treatment, and this feedback will help improve care for others living with HIV.

Gender

ALL

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)