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

NCT05835635 | Not Yet Recruiting

• 1 other identifier: 220817002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Satisfaction; Patient Preference; Quality of Life; Acceptability of Health Care

Keywords

Quality of life; Acceptability; Satisfaction; Preference; HIV; Long acting- cabotegravir

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  72 weeks

Secondary Outcomes (7)

• Evaluate the adherence of patients switching to injectable treatment

  72 weeks

• Evaluate safety of the injectable treatment

  From day 28 to 72 weeks

• Describe percentage of patients who prefer injectable over oral therapy at 72 weeks follow up

  72 weeks

• Monitor the HIV viral load of the patients every 6 months, to follow their health status

  Every 6 months until 72 weeks

• Monitor the lymphocytes CD4 count of the patients every 6 months, to follow their health status

  Every 6 months until 72 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• ViiV Healthcare: collaborator

Study Sites (1)

CICUC

Santiago, Santiago Metropolitan, 3830000, Chile

Location

Related Publications (13)

• 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.

  PMID: 33902356 RESULT

• Swindells 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.

  PMID: 32130809 RESULT

• Overton 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.

  PMID: 33308425 RESULT

• Jaeger 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.

  PMID: 34648734 RESULT

• Orkin 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.

  PMID: 33794181 RESULT

• Cutrell 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.

  PMID: 33730748 RESULT

• Cooper 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.

  PMID: 29141645 RESULT

• Wu 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.

  PMID: 23497257 RESULT

• Tatlock 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.

  PMID: 28292488 RESULT

• Chounta 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.

  PMID: 34056699 RESULT

• Swindells 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.

  PMID: 34261093 RESULT

• Karver 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.

  PMID: 36626155 RESULT

• Orkin 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.

  PMID: 34656207 RESULT

Related Links

• Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Transmission in the United States.
• 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 Suppressed
• Information leaflet for professionals VOCABRIA prolonged-release injectable suspension 600 mg/3ml.
• 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 Healthcare
• HIGHLIGHTS OF PRESCRIBING INFORMATION
• Information leaflet for ptofessionals Vocabria prolonged-release injectable suspension 600 mg/3ml. updated

MeSH Terms

Conditions

Patient Satisfaction; Patient Preference; Patient Acceptance of Health Care; Personal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Maria E Ceballos, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria E Ceballos, MD

CONTACT

+56996739404; meceball@uc.cl

Jimena L Flores, RN

CONTACT

+56993158486; jflores@med.puc.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor School of Medicine

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 28, 2023
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)