Patient SatisfactionCABO-LANCT05835635
Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
An observational study of Patient Satisfaction and Patient Preference, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Patient Preference, Quality of Life
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All HIV patients who meet the inclusion criteria and who are willing to switch from oral to injectable therapy
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
CICUC
Santiago, Santiago Metropolitan, 3830000
Maria E Ceballos, MD, +56996739404, meceball@uc.cl
Jimena L Flores, RN, +56993158486, jflores@med.puc.cl
About this study
Official title: 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.
Read the 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:
- Describe percentage of patients that preferred injectable over oral therapy after 72 weeks follow up
- Evaluate the adherence of patients switching to injectable treatment
- Evaluate safety/tolerability of the injectable treatment
- Monitor the HIV viral load, of the patients every 6 months, to follow their health status
- 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
- Register anthropometric changes.
- Keywords
- Quality of life, Acceptability, Satisfaction, Preference, HIV, Long acting- cabotegravir
- Medical subject headings
- Patient Satisfaction, Patient Preference, Patient Acceptance of Health Care, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
Measured: 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.
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
Measured: 72 weeks
Secondary outcomes (7)
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.
Measured: 72 weeks
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
Measured: From day 28 to 72 weeks
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
Measured: 72 weeks
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.
Measured: Every 6 months until 72 weeks
Monitor the lymphocytes CD4 count of the patients every 6 months, to follow their health status
Absolute Values for lymphocytes CD4 Count by cells/mm3 will be registered at day 1, week 20, 52, and 72.
Measured: Every 6 months until 72 weeks
Monitor the blood chemistry of the patients every 6 months, to follow their health status
Blood chemistry includes creatinine, SGOT, GGT, SGPT, alkaline phosphatases and bilirrubin at day 1, week 20, 52, and 72.
Measured: Every 6 months until 72 weeks
Register anthropometric changes
Height, weight and hip measures will be registered at day 1, week 20, 52, and 72.
Measured: From day 1 to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Maria Elena Ceballos, Pontificia Universidad Catolica de Chile
- Investigators
- Maria E Ceballos, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835635
- Sponsor's protocol ID
- 220817002
- Acronym
- CABO-LA
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
Scarsi KK, Swindells S. The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data? J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211009011. doi: 10.1177/23259582211009011.
PubMed 33902356Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.
PubMed 32130809Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, Garcia Deltoro M, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses MA, Van Solingen-Ristea R, van Eygen V, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005. doi: 10.1016/S0140-6736(20)32666-0. Epub 2020 Dec 9.
PubMed 33308425Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Espanol CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.
PubMed 34648734Orkin C, Oka S, Philibert P, Brinson C, Bassa A, Gusev D, Degen O, Garcia JG, Morell EB, Tan DHS, D'Amico R, Dorey D, Griffith S, Thiagarajah S, St Clair M, Van Solingen-Ristea R, Crauwels H, Ford SL, Patel P, Chounta V, Vanveggel S, Cutrell A, Van Eygen V, Vandermeulen K, Margolis DA, Smith KY, Spreen WR. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study. Lancet HIV. 2021 Apr;8(4):e185-e196. doi: 10.1016/S2352-3018(20)30340-4.
PubMed 33794181Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, Van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MS, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Exploring predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis. AIDS. 2021 Jul 15;35(9):1333-1342. doi: 10.1097/QAD.0000000000002883.
PubMed 33730748Cooper V, Clatworthy J, Harding R, Whetham J; Emerge Consortium. Measuring quality of life among people living with HIV: a systematic review of reviews. Health Qual Life Outcomes. 2017 Nov 15;15(1):220. doi: 10.1186/s12955-017-0778-6.
PubMed 29141645Wu AW, Hanson KA, Harding G, Haider S, Tawadrous M, Khachatryan A, Pashos CL, Simpson KN. Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies. Health Qual Life Outcomes. 2013 Mar 12;11:42. doi: 10.1186/1477-7525-11-42.
PubMed 23497257Tatlock S, Arbuckle R, Sanchez R, Grant L, Khan I, Manvelian G, Spertus JA. Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection. Value Health. 2017 Mar;20(3):430-440. doi: 10.1016/j.jval.2016.09.2410. Epub 2016 Dec 1.
PubMed 28292488Chounta V, Overton ET, Mills A, Swindells S, Benn PD, Vanveggel S, van Solingen-Ristea R, Wang Y, Hudson KJ, Shaefer MS, Margolis DA, Smith KY, Spreen WR. Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M). Patient. 2021 Nov;14(6):849-862. doi: 10.1007/s40271-021-00524-0. Epub 2021 May 31.
PubMed 34056699Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.
PubMed 34261093Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.
PubMed 36626155Orkin C, Bernal Morell E, Tan DHS, Katner H, Stellbrink HJ, Belonosova E, DeMoor R, Griffith S, Thiagarajah S, Van Solingen-Ristea R, Ford SL, Crauwels H, Patel P, Cutrell A, Smith KY, Vandermeulen K, Birmingham E, St Clair M, Spreen WR, D'Amico R. Initiation of long-acting cabotegravir plus rilpivirine as direct-to-injection or with an oral lead-in in adults with HIV-1 infection: week 124 results of the open-label phase 3 FLAIR study. Lancet HIV. 2021 Nov;8(11):e668-e678. doi: 10.1016/S2352-3018(21)00184-3. Epub 2021 Oct 14.
PubMed 34656207
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05835635
- Acronym / sponsor ID
- CABO-LA / 220817002
- Keywords
- Quality of life, Acceptability, Satisfaction, Preference, HIV, Long acting- cabotegravir
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Describe percentage of patients that preferred injectable over oral therapy after 72 weeks follow up
- Evaluate the adherence of patients switching to injectable treatment
- Evaluate safety/tolerability of the injectable treatment
- Monitor the HIV viral load, of the patients every 6 months, to follow their health status
- 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
- Register anthropometric changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HIV patients who meet the inclusion criteria and who are willing to switch from oral to injectable therapy
Key inclusion criteria (6 listed)
- All patients who, according to the recommendations for use, can receive LA- injectable Cabotegravir +Rilpivirine therapy will be invited to participate in the study.
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
7 secondary outcomes
Evaluate the adherence of patients switching to injectable treatment
Time frame: 72 weeks
Evaluate safety of the injectable treatment
Time frame: 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
Monitor the HIV viral load of the patients every 6 months, to follow their health status
Time frame: 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
Monitor the blood chemistry of the patients every 6 months, to follow their health status
Time frame: Every 6 months until 72 weeks
Register anthropometric changes
Time frame: From day 1 to 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Results publication: PubMed 33902356Scarsi KK, Swindells S. The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data? J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211009011. doi: 10.1177/23259582211009011.
- Results publication: PubMed 32130809Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masia M, Latiff G, Pokrovsky V, Bredeek F, Smith G, Cahn P, Kim YS, Ford SL, Talarico CL, Patel P, Chounta V, Crauwels H, Parys W, Vanveggel S, Mrus J, Huang J, Harrington CM, Hudson KJ, Margolis DA, Smith KY, Williams PE, Spreen WR. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. doi: 10.1056/NEJMoa1904398. Epub 2020 Mar 4.
- Results publication: PubMed 33308425Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, Garcia Deltoro M, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses MA, Van Solingen-Ristea R, van Eygen V, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005. doi: 10.1016/S0140-6736(20)32666-0. Epub 2020 Dec 9.
- Results publication: PubMed 34648734Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Espanol CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.
- Results publication: PubMed 33794181Orkin C, Oka S, Philibert P, Brinson C, Bassa A, Gusev D, Degen O, Garcia JG, Morell EB, Tan DHS, D'Amico R, Dorey D, Griffith S, Thiagarajah S, St Clair M, Van Solingen-Ristea R, Crauwels H, Ford SL, Patel P, Chounta V, Vanveggel S, Cutrell A, Van Eygen V, Vandermeulen K, Margolis DA, Smith KY, Spreen WR. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study. Lancet HIV. 2021 Apr;8(4):e185-e196. doi: 10.1016/S2352-3018(20)30340-4.
- Results publication: PubMed 33730748Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, Van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MS, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Exploring predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis. AIDS. 2021 Jul 15;35(9):1333-1342. doi: 10.1097/QAD.0000000000002883.
- Results publication: PubMed 29141645Cooper V, Clatworthy J, Harding R, Whetham J; Emerge Consortium. Measuring quality of life among people living with HIV: a systematic review of reviews. Health Qual Life Outcomes. 2017 Nov 15;15(1):220. doi: 10.1186/s12955-017-0778-6.
- Results publication: PubMed 23497257Wu AW, Hanson KA, Harding G, Haider S, Tawadrous M, Khachatryan A, Pashos CL, Simpson KN. Responsiveness of the MOS-HIV and EQ-5D in HIV-infected adults receiving antiretroviral therapies. Health Qual Life Outcomes. 2013 Mar 12;11:42. doi: 10.1186/1477-7525-11-42.
- Results publication: PubMed 28292488Tatlock S, Arbuckle R, Sanchez R, Grant L, Khan I, Manvelian G, Spertus JA. Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection. Value Health. 2017 Mar;20(3):430-440. doi: 10.1016/j.jval.2016.09.2410. Epub 2016 Dec 1.
- Results publication: PubMed 34056699Chounta V, Overton ET, Mills A, Swindells S, Benn PD, Vanveggel S, van Solingen-Ristea R, Wang Y, Hudson KJ, Shaefer MS, Margolis DA, Smith KY, Spreen WR. Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M). Patient. 2021 Nov;14(6):849-862. doi: 10.1007/s40271-021-00524-0. Epub 2021 May 31.
- Results publication: PubMed 34261093Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.
- Results publication: PubMed 36626155Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.
- Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Transmission in the United States.Link provided by the sponsor.
- A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically SuppressedLink provided by the sponsor.
- Information leaflet for professionals VOCABRIA prolonged-release injectable suspension 600 mg/3ml.Link provided by the sponsor.
- Use of cabotegravir and rilpivirine tablets to control the planned interruption of the injection dose every 2 months with cabotegravir long-acting plus rilpivirine. ViiV HealthcareLink provided by the sponsor.
- HIGHLIGHTS OF PRESCRIBING INFORMATIONLink provided by the sponsor.
- Information leaflet for ptofessionals Vocabria prolonged-release injectable suspension 600 mg/3ml. updatedLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria E Ceballos, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Patient Preference, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria E Ceballos, MD (+56996739404, meceball@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05835635, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.