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

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ClinicalTrials.gov Identifier: NCT04001803
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : September 11, 2019
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)
Estimated Enrollment : 135 participants
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
Estimated Primary Completion Date : November 28, 2019
Estimated Study Completion Date : September 17, 2020

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) questionnaire in staff study subjects based on Likert scale [ Time Frame: Baseline and 4 months ]
    The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  2. Change from Baseline for AIM in staff study subjects [ Time Frame: Baseline and 12 months ]
    The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  3. Change from Baseline for AIM in subjects with HIV infection at 4 months [ Time Frame: Baseline and 4 months ]
    The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  4. Change from Baseline for AIM in subjects with HIV infection [ Time Frame: Baseline and 12 months ]
    The responses for acceptability will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  5. Change from Baseline for intervention appropriateness measure (IAM) in staff study subjects at 4 months [ Time Frame: Baseline and 4 months ]
    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  6. Change from Baseline for IAM in staff study subjects [ Time Frame: Baseline and 12 months ]
    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  7. Change from Baseline for IAM in subjects with HIV infection [ Time Frame: Baseline and 12 months ]
    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  8. Change from Baseline for IAM in subjects with HIV infection at 4 months [ Time Frame: Baseline and 4 months ]
    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  9. Change from Baseline for feasibility of intervention measure (FIM) in staff study subjects at 4 months [ Time Frame: Baseline and 4 months ]
    The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.

  10. Change from Baseline for FIM in staff study subjects [ Time Frame: Baseline and 12 months ]
    The responses for feasibility will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.


Secondary Outcome Measures :
  1. Change from Baseline for facilitators using semi-structure interview (SSI) in staff study subjects at 4 months [ Time Frame: Baseline and 4 months ]
    The organizational facilitators and barriers are assessed using consolidated framework for implementation research (CFIR). CFIR comprises of 39 constructs organized into 5 domains.

  2. Change from Baseline for facilitators using SSI in staff study subjects [ Time Frame: Baseline and 12 months ]
    The organizational facilitators and barriers are assessed using consolidated framework for implementation research (CFIR). CFIR comprises of 39 constructs organized into 5 domains.

  3. Change from Baseline for barriers using SSI in staff study subjects at 4 months [ Time Frame: Baseline and 4 months ]
    The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

  4. Change from Baseline for barriers using SSI in staff study subjects [ Time Frame: Baseline and 12 months ]
    The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

  5. Change from Baseline for facilitators using SSI in subjects with HIV infection [ Time Frame: Baseline and 12 months ]
    The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

  6. Change from Baseline for barriers using SSI in subjects with HIV infection [ Time Frame: Baseline and 12 months ]
    The organizational facilitators and barriers are assessed using CFIR. CFIR comprises of 39 constructs organized into 5 domains.

  7. Number of barriers assessed among clinics using short-term facilitation [ Time Frame: Up to 6 months ]
    The barriers will be assessed by short-term facilitation like coaching calls which will include combination of structured and open-ended questions.

  8. Number of facilitators assessed among clinics using short-term facilitation [ Time Frame: Up to 6 months ]
    The facilitators will be assessed by short-term facilitation like coaching calls which will include combination of structured and open-ended questions.

  9. Number of best practices sharing assessed among clinics using short-term facilitation [ Time Frame: Up to 6 months ]
    The best practice sharing among clinics will be assessed by short-term facilitation like coaching calls which will include combination of structured and open-ended questions.

  10. Change from Baseline for the use of support materials/tool kit of staff study subjects at 4 months [ Time Frame: Baseline and 4 months ]
    The use of support materials/toolkit will be assessed using survey responses to a series of questions.

  11. Change from Baseline for the use of support materials/tool kit of staff study subjects [ Time Frame: Baseline and 12 months ]
    The use of support materials/toolkit will be assessed using survey responses to a series of questions.

  12. Change from Baseline for the use of support materials/toolkit of subjects with HIV infection at 4 months [ Time Frame: Baseline and 4 months ]
    The use of support materials/toolkit will be assessed using survey responses to a series of questions.

  13. Change from Baseline for the use of support materials/toolkit of subjects with HIV infection [ Time Frame: Baseline and 12 months ]
    The use of support materials/toolkit will be assessed using survey responses to a series of questions.

  14. Number of support materials/toolkit used by staff study subjects [ Time Frame: Up to 12 months ]
    The use of support materials/toolkit will be assessed through SSI.

  15. Number of subjects receiving injections within target window at 4 months [ Time Frame: Baseline and 4 months ]
    The implementation of fidelity will be assessed using SSI from the validated CFIR framework.

  16. Number of subjects receiving injections within target window [ Time Frame: Up to 12 months ]
    The implementation of fidelity will be assessed using SSI from the validated CFIR framework.

  17. Implementation sustainability assessed in staff study subjects using program sustainability assessment tool (PSAT) [ Time Frame: At month 12 ]
    The implementation sustainability in staff study subjects will be assessed using PSAT tool. This tool evaluates the capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after conclusion of the study.

  18. Number of survey responses with subject satisfaction at month 1 [ Time Frame: At month 1 ]
    Subject survey responses will be assessed to measure subject satisfaction by calculating timelines of visit, length of visit and subject education.

  19. Number of survey responses with subject satisfaction at month 4 [ Time Frame: At month 4 ]
    Subject survey responses will be assessed to measure subject satisfaction by calculating timelines of visit, length of visit and subject education.

  20. Number of survey responses with subject satisfaction at month 12 [ Time Frame: At months 12 ]
    Subject survey responses will be assessed to measure subject satisfaction by calculating timelines of visit, length of visit and subject education.

  21. Change from Baseline in subject's timeliness of visit [ Time Frame: Baseline and at month 12 ]
    The timeliness of visit for each subject will be assessed using SSI responses.

  22. Change from Baseline in subject's length of visit [ Time Frame: Baseline and at month 12 ]
    The length of hospital visit for each subject will be assessed using SSI responses

  23. Change from Baseline in subject's knowledge about the CAB + RPV LA treatment [ Time Frame: Baseline and at month 12 ]
    The subject's knowledge about CAB + RPV LA treatment will be assessed using SSI responses

  24. Length of subject visit [ Time Frame: At month 1 ]
    The length of subject visit will be assessed from arrival until departure from clinic.

  25. Length of subject visit [ Time Frame: At month 5 ]
    The length of subject visit will be assessed from arrival until departure from clinic.

  26. Length of subject visit [ Time Frame: At month 11 ]
    The length of subject visit will be assessed from arrival until departure from clinic.

  27. Number of subjects with plasma HIV-1 Ribo Nucleic Acid (RNA)<50 copies/milliliter (c/mL) [ Time Frame: Up to 12 months ]
    Plasma samples will be collected from the subject at specific time points. The Abbott RealTime HIV-1 Assay lower limit of detection (LLOD) 40 c/mL, will be used.

  28. Number of subjects with confirmed virologic failure (CVF) [ Time Frame: Up to 12 months ]
    CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL.

  29. Number of subjects with treatment emergent genotypic resistance to CAB and RPV [ Time Frame: Up to 12 months ]
    Blood samples will be collected and used for the analysis of genotypic resistance in subjects with CVF.

  30. Number of subjects with phenotypic resistance to CAB and RPV [ Time Frame: Up to 12 months ]
    Blood samples will be collected and used for the analysis of phenotypic resistance in subjects with CVF.

  31. Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 12 months ]
    An AE is any untoward medical occurrence in a subject or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, and is associated with liver injury and impaired liver function.

  32. Number of subjects who discontinue treatment due to AEs over time [ Time Frame: Up to 12 months ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects who will discontinue the treatment due to AEs will be reported.

  33. Number of subjects with abnormal hematology findings [ Time Frame: Up to 12 months ]
    Blood samples will be collected to measure platelets, red blood cells (RBC) count, white blood cells (WBC) count (absolute), hemoglobin, hematocrit, mean corpuscular volume (MCV), neutrophils, lymphocytes, monocytes, eosinophils and basophils.

  34. Number of subjects with abnormal clinical chemistry findings [ Time Frame: Up to 12 months ]
    Blood samples will be collected to measure blood urea nitrogen (BUN), creatinine, glucose, sodium, potassium, chloride, Total carbon dioxide (CO2), lipase, phosphate, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatine phosphokinase (CK) and creatinine clearance.

  35. Number of subjects with abnormal urinalysis [ Time Frame: Up to 12 months ]
    Urine samples will be collected and analyzed from subjects at indicated time points.

  36. Number of subjects with injection site reactions (ISRs) over time [ Time Frame: Up to 12 months ]
    The ISRs will be assessed through-out the study. All ISRs that are either serious, grade 3 or higher or persisting beyond 2 weeks will be discussed with the Medical Monitor to determine etiology and assess appropriate continued study participation.

  37. Change from Baseline in hematology parameters of platelet count, WBC count, basophil count, eosinophil count, lymphocyte count , monocyte count and neutrophil count (all 10^9 cells/Liter) [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure hematology parameters including: platelet count, WBC count, basophil count, eosinophil count, lymphocyte count , monocyte count and neutrophil count.

  38. Change from Baseline in hematology parameters-RBC count [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure RBC count.

  39. Change from Baseline in hematology parameters- Hemoglobin [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure Hemoglobin.

  40. Change from Baseline in hematology parameter-hematocrit [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure hematocrit.

  41. Change from Baseline in hematology parameter-MCV [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure MCV.

  42. Change from Baseline in clinical laboratory parameters of sodium, potassium, carbon-dioxide, chloride and glucose (all millimoles per liter) [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure sodium, potassium, carbon-dioxide, chloride, and glucose.

  43. Change from Baseline in clinical laboratory parameters of creatinine and total bilirubin [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure creatinine and total bilirubin

  44. Change from Baseline in clinical laboratory parameters of ALT, ALP and AST [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure ALT, ALP and AST.

  45. Change from Baseline in clinical laboratory parameter-Creatine phosphokinase [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure Creatine phosphokinase.

  46. Change from Baseline in clinical laboratory parameter-Creatinine clearance [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure Creatinine clearance

  47. Change from Baseline in clinical laboratory parameter-lipase [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure lipase.

  48. Change from Baseline in clinical laboratory parameters-BUN [ Time Frame: Baseline and Up to 12 months ]
    Blood samples will be collected to measure BUN.

  49. Change from Baseline in urinalysis parameters, urine albumin to creatinine ratio [ Time Frame: Baseline and Up to 12 months ]
    Urine samples will be collected at the specified timepoints, for assessment of urine albumin to creatinine ratio.

  50. Change from Baseline in urinalysis parameters, urine protein to creatinine ratio [ Time Frame: Baseline and Up to 12 months ]
    Urine samples will be collected at the specified timepoints, for assessment of urine protein to creatinine ratio.

  51. Change from Baseline in urinalysis parameters, urine phosphate [ Time Frame: Baseline and Up to 12 months ]
    Urine samples will be collected at the specified timepoints, for assessment of urine phosphate.



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.


Layout table for eligibility information
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


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, California
GSK Investigational Site Recruiting
Sacramento, California, United States, 95825
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jason A Flamm         
United States, District of Columbia
GSK Investigational Site Recruiting
Washington, District of Columbia, United States, 20017
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Richard Elion         
United States, Florida
GSK Investigational Site Recruiting
Jacksonville, Florida, United States, 32209
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Malleswari Ravi         
GSK Investigational Site Recruiting
Miami Beach, Florida, United States, 33140
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Michael B. Wohlfeiler         
United States, Georgia
GSK Investigational Site Recruiting
Atlanta, Georgia, United States, 30309
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Christine A Zurawski         
United States, Michigan
GSK Investigational Site Recruiting
Berkley, Michigan, United States, 48072
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Paul Benson         
United States, Mississippi
GSK Investigational Site Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Leandro Mena         
United States, Missouri
GSK Investigational Site Recruiting
Kansas City, Missouri, United States, 64111
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Blair Thedinger         
United States, Texas
GSK Investigational Site Recruiting
Dallas, Texas, United States, 75208
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Gary Sinclair         
Sponsors and Collaborators
ViiV Healthcare
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT04001803     History of Changes
Other Study ID Numbers: 209493
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
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 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Rilpivirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents