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Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04001803
Recruitment Status : Completed
First Posted : June 28, 2019
Results First Posted : January 10, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity of anti-retroviral therapy (ART), despite advances in development of new ART, which provides extensive insight in management of HIV-infected individuals. Cabotegravir (CAB) is a potent integrase inhibitor (INI) and rilpivirine (RPV) is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI). A two-drug regimen (DR)with CAB plus RPV long acting (LA) product offers many potential advantages over daily oral regimens including better tolerability, improved compliance, adherence, less likely to develop resistance, and overall treatment satisfaction in virologically suppressed subjects. This is a single-arm, open-label, multicenter, short term facilitation study to evaluate the effect of an implementation strategy on the degree of acceptability, appropriateness, feasibility, fidelity and sustainability of clinical practices to deliver the CAB+RPV LA regimen to HIV infected subjects and to also measure subject satisfaction by recording timeliness of visits, length of visit and their education. Approximately 135 subjects will be enrolled in the study and the total duration of the study will be approximately 52-weeks.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: CAB LA+RPV LA Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Qualitative Hybrid III Implementation Study to Identify and Evaluate Strategies for Successful Implementation of the Cabotegravir + Rilpivirine Long-acting Injectable Regimen in the US
Actual Study Start Date : July 8, 2019
Actual Primary Completion Date : October 5, 2020
Actual Study Completion Date : March 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Rilpivirine

Arm Intervention/treatment
Experimental: Subjects with HIV infection
HIV-infected subjects receiving CAB LA+RPV LA will be included in this arm.
Drug: CAB LA+RPV LA
Subjects will receive one tablet of CAB 30 milligram(mg) + RPV 25 mg once daily from Day 1 for 1 month. During month 1, subjects will receive 600 mg of CAB LA injection+ 900 mg of RPV LA injection. Following Month 1, subjects will receive 400mg of CAB LA + 600mg of RPV LA at each subsequent injection.




Primary Outcome Measures :
  1. Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4 [ Time Frame: Baseline and Month 4 ]
    AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  2. Change From Baseline in AIM Total Score in Staff Study Participants at Month 12 [ Time Frame: Baseline and Month 12 ]
    AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  3. Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4 [ Time Frame: Baseline and Month 4 ]
    AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  4. Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12 [ Time Frame: Baseline and Month 12 ]
    AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  5. Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4 [ Time Frame: Baseline and Month 4 ]
    IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  6. Change From Baseline in IAM Score in Staff Study Participants at Month 12 [ Time Frame: Baseline and Month 12 ]
    IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  7. Change From Baseline in IAM Score in Participants With HIV Infection at Month 4 [ Time Frame: Baseline and Month 4 ]
    IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  8. Change From Baseline in IAM Score in Participants With HIV Infection at Month 12 [ Time Frame: Baseline and Month 12 ]
    IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  9. Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4 [ Time Frame: Baseline and Month 4 ]
    FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  10. Change From Baseline for FIM Total Score in Staff Study Participants at Month 12 [ Time Frame: Baseline and Month 12 ]
    FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.


Secondary Outcome Measures :
  1. Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 [ Time Frame: At Month 4 ]
    The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented.

  2. Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 [ Time Frame: At Month 12 ]
    The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented.

  3. Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants [ Time Frame: Baseline and Month 4 ]
    BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, same perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.

  4. Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants [ Time Frame: Baseline and Month 12 ]
    BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, same perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline.

  5. Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 [ Time Frame: At Month 12 ]
    The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented.

  6. Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 [ Time Frame: At Month 12 ]
    Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented.

  7. Number of Barriers Assessed Among Clinics Using Short-term Facilitation [ Time Frame: Up to 6 months ]
    The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.

  8. Number of Facilitators Assessed Among Clinics Using Short-term Facilitation [ Time Frame: Up to 6 months ]
    The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.

  9. Number of Best Practices Assessed Among Clinics Using Short-term Facilitation [ Time Frame: Up to 6 months ]
    The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants.

  10. Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 [ Time Frame: At Month 4 ]
    Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.

  11. Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 [ Time Frame: At Month 12 ]
    Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs.

  12. Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 [ Time Frame: At Month 4 ]
    Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented.

  13. Number of Participants Receiving Injections Within Target Window at Month 4 [ Time Frame: At Month 4 ]
    Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date.

  14. Number of Participants Receiving Injections Within Target Window at Month 12 [ Time Frame: At Month 12 ]
    Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date.

  15. Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores [ Time Frame: At Month 12 ]
    Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts)

  16. HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1 [ Time Frame: At Month 1 ]
    Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.

  17. HIV-TSQs Scores at Month 4 [ Time Frame: At Month 4 ]
    Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.

  18. HIV-TSQs Scores at Month 12 [ Time Frame: At Month 12 ]
    Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment.

  19. Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit [ Time Frame: At Month 12 ]
    The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable.

  20. Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit [ Time Frame: At Month 12 ]
    Number of participants with the reported time spent in clinic/practice for each injection visit is presented.

  21. Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment [ Time Frame: At Month 12 ]
    Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable.

  22. Length of Participant Visit [ Time Frame: At Months 1, 5 and 11 ]
    Length of visit was calculated by subtracting the arrival time (Lead time [actual start time of appointment - arrival time] + process time [actual end time of appointment - actual start time of appointment]) from actual end time of appointment.

  23. Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) [ Time Frame: Up to Month 12 ]
    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach.

  24. Percentage of Participants With Confirmed Virologic Failure (CVF) [ Time Frame: Up to Month 12 ]
    Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (>=)200 copies/mL after prior suppression to <200 copies/mL.

  25. Number of Participants With Treatment Emergent Genotypic Resistance to CAB and RPV [ Time Frame: Up to Month 12 ]
    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent genotypic resistance is summarized.

  26. Number of Participants With Treatment Emergent Phenotypic Resistance to CAB and RPV [ Time Frame: Up to Month 12 ]
    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent phenotypic resistance is summarized.

  27. Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs) [ Time Frame: Up to Month 12 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (>=5%) non-SAEs are presented.

  28. Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time [ Time Frame: Up to Month 12 ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off.

  29. Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline [ Time Frame: Up to Month 12 ]
    Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.

  30. Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline [ Time Frame: Up to Month 12 ]
    Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms.

  31. Number of Participants With Urinalysis Result of Potential Clinical Importance [ Time Frame: Up to Month 12 ]
    Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented.

  32. Number of Participants With Injection Site Reactions (ISRs) Over Time [ Time Frame: Up to Month 12 ]
    Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented.

  33. Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the hematology parameters: Platelets, WBCs, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  34. Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  35. Change From Baseline in Hematology Parameter: Hemoglobin [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  36. Change From Baseline in Hematology Parameter: Hematocrit [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  37. Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV) [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  38. Absolute Values of the Hematology Parameters: Platelet Count, WBC Count , Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils [ Time Frame: Up to Month 12 ]
    Blood samples were collected for the analysis of hematology parameters including platelet count, WBCs, basophils, eosinophils, lymphocytes, monocytes and neutrophils

  39. Absolute Values of Hematology Parameter: RBC Count [ Time Frame: Up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: RBC count.

  40. Absolute Values of Hematology Parameter: Hemoglobin [ Time Frame: Up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: Hemoglobin

  41. Absolute Values of Hematology Parameter: Hematocrit [ Time Frame: Up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1)

  42. Absolute Values of Hematology Parameter: Erythrocytes MCV [ Time Frame: Up to Month 12 ]
    Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV.

  43. Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  44. Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  45. Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  46. Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.

  47. Change From Baseline in Clinical Laboratory Parameter: Lipase [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

  48. Change From Baseline in Clinical Laboratory Parameter: Albumin [ Time Frame: Baseline and up to Month 12 ]
    Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

  49. Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate. [ Time Frame: Up to Month 12 ]
    Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate.

  50. Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin [ Time Frame: Up to Month 12 ]
    Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin.

  51. Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase [ Time Frame: Up to Month 12 ]
    Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase.

  52. Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) [ Time Frame: Up to Month 12 ]
    Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA

  53. Absolute Values of Clinical Laboratory Parameter: Lipase [ Time Frame: Up to Month 12 ]
    Blood samples were collected for the analysis of clinical chemistry parameter: Lipase.

  54. Absolute Values of Clinical Laboratory Parameter: Albumin [ Time Frame: Up to Month 12 ]
    Blood samples were collected for the analysis of clinical chemistry parameter: Albumin.


Other Outcome Measures:
  1. Change From Baseline in Urinalysis Parameters: Urine Albumin to Creatinine Ratio [ Time Frame: Baseline and up to Month 12 ]
    Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted.

  2. Change From Baseline in Urinalysis Parameters: Urine Protein to Creatinine Ratio [ Time Frame: Baseline and up to Month 12 ]
    Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted.

  3. Change From Baseline in Urinalysis Parameters: Urine Phosphate [ Time Frame: Baseline and up to Month 12 ]
    Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be able to understand and comply with protocol requirements, instructions, and restrictions;
  • Understand the long-term commitment to the study and be likely to complete the study as planned;
  • Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.).

All Participants eligible for enrolment in the study must meet all of the following criteria:

  • Aged 18 years or older at the time of signing the informed consent.
  • HIV-1 infected and must be on an active highly active antiretroviral therapy (HAART) (2 or 3 drug) 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 treatment failure (HIV-1 RNA >=200 c/mL).

Acceptable stable ARV regimens prior to Screening include 2 NRTIs plus:

• INI (either the initial or second Combination antiretroviral therapy (cART) regimen)

  • NNRTI (either the initial or second cART regimen)
  • Boosted prediction interval (PI) (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability)
  • Any suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of dolutegravir (DTG)/RPV

    - Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: at least one within 6 months prior to Screening;

    • Plasma HIV-1 RNA <50 c/mL at Screening;
    • A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test at screen and at Day 1), not lactating, and at least one of the following conditions applies:

      1. Non-reproductive potential defined as:
  • Pre-menopausal females with one of the following:

    • Documented tubal ligation
    • Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
    • Hysterectomy
    • Documented Bilateral Oophorectomy
  • Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

    b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.

    - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.

Exclusion Criteria:

  • Within 6 months prior to Screening, plasma HIV-1 RNA measurement >=50 c/mL;
  • During the previous 12 months, any confirmed HIV-1 RNA measurement >=200 c/mL Exclusionary medical conditions
  • 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, except cutaneous Kaposi's sarcoma not requiring systemic therapy, and Cluster of Differentiation (CD4+) counts <200 cells/microliter are not exclusionary
  • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
  • Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low.
  • Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
  • The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
  • Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows:

    • Participants positive for HBsAg are excluded;
    • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
  • Participants who are anticipated to require HCV treatment within 12 months must be excluded. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded; investigators must carefully assess if therapy specific for HCV infection is required. (HCV treatment on study may be permitted, following consultation and approval of the direct acting antiviral (DAA) drug based therapy being considered with the medical monitor).
  • Participants with HCV co-infection will be allowed entry into this study if:

    • Liver enzymes meet entry criteria
    • HCV Disease has undergone appropriate work-up, and is not advanced. Additional information (where available) on participants with HCV coinfection at screening should include results from any liver biopsy, Fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
    • In the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility

      • Fib-4 score >3.25 is exclusionary
      • Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation Fibrosis 4 Score Formula: (Age x AST) / (Platelets x ( sqr [ 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 (<=325 milligram (mg) per day) or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease.
  • Corrected QT interval (QTc [Bazett]) >450 milli second (msec) or QTc (Bazett) >480 msec for subjects with bundle branch block). Exclusionary Laboratory Values or Clinical Assessments (a single repeat to determine eligibility is allowed).
  • Any evidence of primary resistance based on the presence of any major known INI or NNRTI resistance-associated mutation, except for K103N, (International acquired immune deficiency syndrome [AIDS] Society [IAS]-USA) by any historical resistance test result.
  • ALT >=5 × Upper Limit Normal (ULN) or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin) over the last 6 months.
  • 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 mL/min/1.73meter^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

Concomitant Medications

  • 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 with the exception of isoniazid (isonicotinylhydrazid [INH]);
    • anti-coagulation agents;
    • Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Participants using short-term (e.g. <=21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment.
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  • Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility.
  • Subjects receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication. Note: Any prohibited medications that decrease CAB or RPV concentrations should be discontinued for a minimum of four weeks or a minimum of three half-lives (whichever is longer) prior to the first dose and any other prohibited medications should be discontinued for a minimum of two weeks or a minimum of three half-lives (whichever is longer) prior to the first dose.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001803


Locations
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United States, California
GSK Investigational Site
Sacramento, California, United States, 95825
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20017
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
GSK Investigational Site
Miami Beach, Florida, United States, 33140
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30309
United States, Michigan
GSK Investigational Site
Berkley, Michigan, United States, 48072
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64111
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75208
Sponsors and Collaborators
ViiV Healthcare
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
  Study Documents (Full-Text)

Documents provided by ViiV Healthcare:
Study Protocol  [PDF] November 16, 2020
Statistical Analysis Plan  [PDF] October 29, 2020

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT04001803    
Other Study ID Numbers: 209493
First Posted: June 28, 2019    Key Record Dates
Results First Posted: January 10, 2022
Last Update Posted: May 17, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ViiV Healthcare:
Antiretroviral therapy, HIV infections, cabotegravir, rilpivirine, long-acting intramuscular injection,
Additional relevant MeSH terms:
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HIV Infections
Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases