Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPontificia Universidad Catolica de Chile
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
All HIV patients who meet the inclusion criteria and who are willing to switch from oral to injectable therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluate the level of satisfaction of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up.
Level of satisfaction of HIV treatment will be measured by HIVTSQs (HIV Treatment Satisfaction Questionnaire) at day one, week 4,12, 36,52 and 72. Questionnaire produce a Treatment Satisfaction score (range: 0 to 66). The higher the score, the greater the satisfaction with treatment.
Time frame
72 weeks2
Evaluate the level of acceptance of treatment of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up.
Acceptance of treatment will be measured by ACCEPT questionnaire (Chronic Treatment Acceptance Questionnaire) at day 1, week 36 and week 72. Questionnaire score has ranges from 0 to 66. The higher the score, indicates greater acceptance
Time frame
72 weeks3
Evaluate the level of quality of life of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up.
Quality of life will be evaluated by MOS-HIV (Medical Outcomes Study HIV Health Survey) Questionnaires at day 1, weeks 4,36,60 and 72. Questionnaire score has ranges from 0 to 100. The higher the score, indicates better health
Time frame
72 weeksSecondary outcomes
1
Evaluate the adherence of patients switching to injectable treatment
Patient adherence will be measured at 72 weeks, through the number of injections that the patient attends.
Time frame
72 weeks2
Evaluate safety of the injectable treatment
The evaluation of safety will be monitored through incidence of All Drug related AEs and SAEs, AEs leading to discontinuations
Time frame
From day 28 to 72 weeks3
Describe percentage of patients who prefer injectable over oral therapy at 72 weeks follow up
Patient´s preference will be described by "SOLAR preference questionnaire" at week 72 by the percentaqe of patients that prefer injectable over oral therapy
Time frame
72 weeks4
Monitor the HIV viral load of the patients every 6 months, to follow their health status
HIV-1 RNA by Copies RNA/mL will be registrered at day 1, week 20, 52, and 72.
Time frame
Every 6 months until 72 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pontificia Universidad Catolica de Chile
Lead sponsor
ViiV Healthcare
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: