Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine (CABO-LA)

April 1, 2024 updated by: Maria Elena Ceballos, Pontificia Universidad Catolica de Chile

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Foreign studies have shown that long-acting (LA) injectable Cabotegravir + Rilpivirine is effective and well tolerated in the long term, demonstrating non-inferiority in relation to oral antiretroviral therapy. One of the main advantages described is that patients report a better quality of life and greater satisfaction with their new antiretroviral therapy.

Currently in Chile, HIV patients have only access to oral antiretroviral therapy as part of their health coverage, either in public ( FONASA) or at private ( ISAPRES). Several issues regarding oral antiretroviral therapy have been detected, including: a) patients who have been in treatment for a long time, often complain of being tired of taking 1 or more pills daily, which might directly affect adherence and success of treatment, b) some patients complain about gastrointestinal intolerance, associated with oral therapy; and c) patients who have to travel abroad for longer than a month, have problems to get an extra dose, in order to adhere to their antiretroviral treatment.

That is why, the possibility of receiving a bimonthly injectable antiretroviral therapy, becomes an attractive alternative for our patients.

Studies evaluating efficacy and security of LA-injectable Cabotegravir + rilpivirine were ATLAS, ATLAS-2M and FLAIR. ATLAS and ATLAS-2M only included 26 and 45 Latin American patients (Argentina and Mexico) from a total of 616 and 1045 participants, respectively. FLAIR study did not include Latin American individuals. Since the majority of patients included in the registration studies were not of Hispanic or Latino ethnicities, it is important to evaluate, in population living in Chile, the real-life impact of Cabotegravir + Rilpivirine injectable treatment on the level of satisfaction, in experienced patients and how it will affect them in the long-term period.

Injectable therapy with Cabotegravir + Rilpivirine needs to be administered by a third person, in an authorized place for such procedures, and requires refrigeration. For this reason, starting the program as a part of a study facilitates the logistic implementation of such program.

The objective of this study is to evaluate, in real life, the level of satisfaction, acceptance of treatment, and quality of life in a group of HIV patients treated in HIV consultation at Red Salud UC-Christus, in Santiago de Chile, who switch to LA injectable therapy Cabotegravir + Rilpivirine, during a 72 weeks follow-up. In order to measure these items, the investigators will use validated instruments (questionnaires).

III. Hypotheses The change from oral to injectable antiretroviral therapy in HIV patients is associated with a high level of satisfaction, good acceptance of treatment, and better quality of life, without affecting adherence to treatment, keeping undetectable HIV viral load an stable CD4 count, and with few serious adverse effects related to injectable therapy.

IV. Objectives Primary Objective: Evaluate the level of satisfaction, acceptance of treatment, and quality of life of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up

Secondary Objectives:

  1. Describe percentage of patients that preferred injectable over oral therapy after 72 weeks follow up
  2. Evaluate the adherence of patients switching to injectable treatment
  3. Evaluate safety/tolerability of the injectable treatment
  4. Monitor the HIV viral load, of the patients every 6 months, to follow their health status
  5. Monitor the CD4 count of the patients every 6 months, to follow their health status 6 Monitor blood chemistry of the patients every 6 months, to follow their health status

7. Register anthropometric changes.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria E Ceballos, MD
  • Phone Number: +56996739404
  • Email: meceball@uc.cl

Study Contact Backup

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 3830000
        • CICUC
        • Contact:
          • Maria E Ceballos, MD
          • Phone Number: +56996739404
          • Email: meceball@uc.cl
        • Contact:
        • Sub-Investigator:
          • Alvaro M Rojas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All HIV patients who meet the inclusion criteria and who are willing to switch from oral to injectable therapy

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the level of satisfaction of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up.
Time Frame: 72 weeks
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.
72 weeks
Evaluate the level of acceptance of treatment of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up.
Time Frame: 72 weeks
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
72 weeks
Evaluate the level of quality of life of undetectable HIV patients who switch from oral to injectable antiretroviral treatment at 72 weeks follow up.
Time Frame: 72 weeks
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
72 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the adherence of patients switching to injectable treatment
Time Frame: 72 weeks
Patient adherence will be measured at 72 weeks, through the number of injections that the patient attends.
72 weeks
Evaluate safety of the injectable treatment
Time Frame: From day 28 to 72 weeks
The evaluation of safety will be monitored through incidence of All Drug related AEs and SAEs, AEs leading to discontinuations
From day 28 to 72 weeks
Describe percentage of patients who prefer injectable over oral therapy at 72 weeks follow up
Time Frame: 72 weeks
Patient´s preference will be described by "SOLAR preference questionnaire" at week 72 by the percentaqe of patients that prefer injectable over oral therapy
72 weeks
Monitor the HIV viral load of the patients every 6 months, to follow their health status
Time Frame: Every 6 months until 72 weeks
HIV-1 RNA by Copies RNA/mL will be registrered at day 1, week 20, 52, and 72.
Every 6 months until 72 weeks
Monitor the lymphocytes CD4 count of the patients every 6 months, to follow their health status
Time Frame: Every 6 months until 72 weeks
Absolute Values for lymphocytes CD4 Count by cells/mm3 will be registered at day 1, week 20, 52, and 72.
Every 6 months until 72 weeks
Monitor the blood chemistry of the patients every 6 months, to follow their health status
Time Frame: Every 6 months until 72 weeks
Blood chemistry includes creatinine, SGOT, GGT, SGPT, alkaline phosphatases and bilirrubin at day 1, week 20, 52, and 72.
Every 6 months until 72 weeks
Register anthropometric changes
Time Frame: From day 1 to 72 weeks
Height, weight and hip measures will be registered at day 1, week 20, 52, and 72.
From day 1 to 72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

ViiV Healthcare

Investigators

  • Principal Investigator: Maria E Ceballos, MD, Pontificia universidad catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 220817002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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