Phase 3
N=430
A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04399551 ↗Enrolled (actual)
430
Serious AEs
4.0%
Results posted
May 2023
Primary outcome: Primary: Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 — 3.8; 3.9; 0.28; 0.33 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CAB OLI (Drug); CAB LA (Drug); RPV OLI (Drug); RPV LA (Drug); Continuous Quality Improvement (CQI) calls (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 |
3.8; 3.9; 0.28; 0.33 | — |
| PRIMARY Change From Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 |
3.8; 3.9; 0.22; 0.31 | — |
| PRIMARY Change From Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 |
4.0; 4.0; 0.06; 0.34 | — |
| PRIMARY Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Acceptability |
28; 28; 0; 0; 3; 1 | — |
| PRIMARY Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Appropriateness |
16; 19; 24; 19; 2; 4 | — |
| PRIMARY Number of Participants That Discussed Themes Arising Out of Qualitative Semi-structured Interviews Which Are Coded as Feasibility |
10; 7; 22; 22; 16; 19 | — |
| SECONDARY Number of Staff Study Participants That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) |
0; 1; 2; 0; 1; 3 | — |
| SECONDARY Number of Staff Study Participants That Discussed Barriers for Acceptability Assessed Via SSIs |
1; 1 | — |
| SECONDARY Number of Staff Study Participants That Discussed Facilitators for Appropriateness Assessed Via SSIs |
1; 2; 0; 2; 1; 1 | — |
| SECONDARY Number of Staff Study Participants That Discussed Barriers for Appropriateness Assessed Via SSIs |
0; 0 | — |
| SECONDARY Number of Staff Study Participants That Discussed Facilitators for Feasibility Assessed Via SSIs |
2; 3; 0; 1; 2; 2 | — |
| SECONDARY Number of Staff Study Participants That Discussed Barriers for Feasibility Assessed Via SSIs |
0; 0 | — |
| SECONDARY Change From Baseline in Implementation Leadership Scale (ILS) Score at Month 12 |
2.3; 2.0; -0.1; 0.2 | — |
| SECONDARY Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12 |
2.5; 2.8; 2.7; 2.6 | — |
| SECONDARY Number of Modifications Reported by SSPs Assessed Via FRAME-IS |
15; 7; 10; 2; 5; 2 | — |
| SECONDARY Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course |
23 | — |
| SECONDARY Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed Via Questionnaire |
71; 134; 99; 48; 19; 8 | — |
| SECONDARY Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed Via Questionnaire |
190; 100; 54; 25; 5; 5 | — |
| SECONDARY Number of Participants Rating Acceptability With the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed Via Questionnaire |
140; 151; 72; 11; 0; 5 | — |
| SECONDARY Number of Participants Rating Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed Via Questionnaire |
163; 154; 51; 6; 0; 5 | — |
| SECONDARY Number of Participants Taking Time Off From Work to Attend Appointment Assessed Via Questionnaire |
27; 20; 5; 3; 9; 20 | — |
| SECONDARY Number of Participants With Time it Took Them to Get to the Clinic Where They Receive HIV Treatment/Check-ups Assessed Via Questionnaire |
66; 138; 87; 44; 39; 5 | — |
| SECONDARY Number of Participants Who Seek Additional Care From a Dependent to Attend Appointment Assessed Via Questionnaire |
16; 318; 39; 6 | — |
| SECONDARY Number of Participants That Endorsed Type of Transportation Used to Attend Appointments |
13; 12; 164; 49; 138; 3 | — |
| SECONDARY Number of Participants Taking Time Off From Work to Recover From Any Injection Site Reaction Issue Assessed Via Questionnaire |
294; 45; 9; 7; 5; 16 | — |
| SECONDARY Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed Via Questionnaire |
175; 154; 43; 4; 0; 3 | — |
| SECONDARY Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed Via Questionnaire |
158; 153; 25; 2; 0; 39 | — |
| SECONDARY Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed Via Questionnaire |
234; 112; 23; 4; 0; 6 | — |
| SECONDARY Number of Participants That Rated Perceived Knowledge About CAB+RPV Injection Treatment Assessed Via Questionnaire |
124; 188; 57; 6; 0; 4 | — |
| SECONDARY Number of Participants With Appointment Reminders Received Assessed Via Questionnaire |
80; 275; 48; 161; 21; 3 | — |
| SECONDARY Number of Participants Who Rated Helpfulness of Appointment Outside of Typical Work Times Assessed Via Questionnaire |
135; 123; 50; 38; 28; 5 | — |
| SECONDARY Number of Participants That Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed Via Questionnaire |
283; 75; 15; 1; 1; 4 | — |
| SECONDARY Number of Participants With Things Tried to Reduce Soreness Following Injections Assessed Via Questionnaire |
139; 20; 19; 87; 71; 61 | — |
| SECONDARY Number of PSPs That Discussed Facilitators for Acceptability Assessed Via Semi Structured Interviews (SSIs) |
105; 100; 82; 76; 66; 64 | — |
| SECONDARY Number of PSPs That Discussed Barriers for Acceptability Assessed Via SSIs |
67; 33; 11; 11 | — |
| SECONDARY Number of PSPs That Discussed Facilitators for Appropriateness Assessed Via SSIs |
— | — |
| SECONDARY Number of PSPs That Discussed Barriers for Appropriateness Assessed Via SSIs |
22; 12 | — |
| SECONDARY Number of PSPs That Discussed Facilitators for Feasibility Assessed Via SSIs |
102; 69; 65; 57; 57; 52 | — |
| SECONDARY Number of PSPs That Discussed Barriers for Feasibility Assessed Via SSIs |
38; 23; 21; 14 | — |
| SECONDARY Change From Baseline in Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12 |
4.55; 0.10 | — |
| SECONDARY Change From Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12 |
4.47; 0.13 | — |
| SECONDARY Change From Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12 |
4.51; 0.07 | — |
| SECONDARY Associated Person Clinical Sustainability Assessment Tool (APCSAT) Average Domain Score at Month 12 |
5.57; 5.58; 5.00; 5.05; 5.37; 5.49 | — |
| SECONDARY Percentage of PSP Receiving Injections Within Target Window |
99; 93; 91; 91; 94; 91 | — |
| SECONDARY Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (c/ml) |
99; 96; 93; 86; 87 | — |
| SECONDARY Number of Participants With Confirmed Virologic Failure (CVF) Over Time |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of PSPs With Adverse Events (AEs) And Serious AEs (SAEs) |
420; 15 | — |
| SECONDARY Number of PSPs Discontinuing Treatment Due to AEs |
2 | — |
| SECONDARY Number of PSP With Preference for Therapy Assessed Via Preference Questionnaire |
2; 275; 0; 2; 100 | — |
Summary
The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants [PSP]) as well as the healthcare providers at the investigator site level (staff study participants [SSP]). SSPs consists of 2 groups: standard and enhanced arm.
Eligibility Criteria
Inclusion Criteria
- Participants aged 18 years or older at the time of signing the informed consent.
- HIV-1 infected and must be suppressed on a guideline recommended active Highly active antiretroviral therapy (HAART) regimen for at least 6 months prior to screening. Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for virologic failure (on treatment HIV-1 RNA more than or equal to [>=]200 c/mL).
- Documented evidence of at least two plasma HIV-1 RNA measurements =50 c/mL.
- During the previous 12 months, any confirmed HIV-1 RNA measurement >=200 c/mL.
- Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study.
- Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy, and historical or current Cluster of Differentiation 4 (CD4)+ counts )3.25 is exclusionary.
- Fib-4 score 1.45-3.25 requires Medical Monitor consultation Fibrosis 4 score formula:
(Age times Aspartate aminotransferase [AST]) / (Platelets times (square [Alanine aminotransferase]{ALT}).
- Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
- History of liver cirrhosis with or without hepatitis viral co-infection.
- Ongoing or clinically relevant pancreatitis.
- Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to inclusion.
- Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [ =5 times the upper limit of normal (ULN) or ALT >=3 times ULN and bilirubin >=1.5 times ULN (with >35 percent [%] direct bilirubin).
- Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.
- Participant has estimated creatinine clearance <50 milliliters per minute (mL/min)/1.73 m^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.
- Treatment with any of the following agents within 28 days of Day 1:
- Radiation therapy.
- Cytotoxic chemotherapeutic agents.
- Tuberculosis therapy except for isoniazid (isonicotinylhydrazid [INH]).
- Anti-coagulation agents.
- Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
- Use of medicatio
Data sourced from ClinicalTrials.gov (NCT04399551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.