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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"false","IpdInfoTypeIcf":"false","IpdInfoTypeCsr":"false","IpdInfoTypeProtocol":"false","IpdInfoTypeSap":"false","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"false","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":"true"},"PatientLevelData":"false","SharingIpd":"No","acronym":"","allocation":"Non-randomized","arm_groups":[{"arm_group_label":"PLS UAT Testing","arm_group_description":"","arm_type":"Other"}],"assignment":"Single Group Assignment","brief_summary":"This is for PLS UAT Testing for ViiV study.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"brief title brief titlebrief titlebrief titlebrief titlebrief titlebrief titlebrief titlebrief titlebrief titlebrief titlebrief title","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"05/01/2019 15:53:56","criteria":"Inclusion Criteria:\n - Be able to understand and comply with protocol requirements, instructions, and restrictions;\n - Understand the long-term commitment to the study and be likely to complete the study as planned;\n - 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.).\nAll Participants eligible for enrolment in the study must meet all of the following criteria:\nAGE\n - Aged 18 years or older at the time of signing the informed consent.\nTYPE OF PARTICIPANT AND DIAGNOSIS INCLUDING DISEASE SEVERITY\n - 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).\nAcceptable stable antiretroviral (ARV) regimens prior to Screening include 2 Non-nucleoside reverse transcriptase inhibitors (NRTIs) plus:\n•\tIntegrase inhibitor (INI) (either the initial or second Combination antiretroviral therapy (cART) regimen)\n•\tNon-nucleoside reverse transcriptase inhibitor (NNRTI) (either the initial or second cART regimen)\n•\tBoosted 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) \n•\tAny suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of DTG/RPV\n - 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;\n - Plasma HIV-1 RNA <50 c/mL at Screening;\nSEX\n - A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at Day 1), not lactating, and at least one of the following conditions applies:\na. Non-reproductive potential defined as:\n•\tPre-menopausal females with one of the following:\no\tDocumented tubal ligation\no\tDocumented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion\no\tHysterectomy\no\tDocumented Bilateral Oophorectomy\n•\tPostmenopausal 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.\nb. 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.\n INFORMED CONSENT\n - 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.\n\nExclusion Criteria:\n HIV-1 RNA\n - Within 6 months prior to Screening, plasma HIV-1 RNA measurement >=50 c/mL;\n - During the previous 12 months, any confirmed HIV-1 RNA measurement >=200 c/mL Exclusionary medical conditions\n - Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study\n - 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 CD4+ counts <200 cells/microliter are not exclusionary\n - 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.\n - 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.\n - 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.\n - The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.\n - 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 DNA as follows:\n•\tParticipants positive for HBsAg are excluded;\n•\tParticipants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded\nNote: 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.\n - 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 DAA based therapy being considered with the medical monitor).\n - Participants with HCV co-infection will be allowed entry into this study if:\n•\tLiver enzymes meet entry criteria\n•\tHCV 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.\n•\tIn the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility \no\tFib-4 score >3.25 is exclusionary\no\tFib-4 scores 1.45 – 3.25 requires Medical Monitor consultation\nFibrosis 4 Score Formula: (Age x AST) / (Platelets x ( sqr [ ALT ])\n - 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).\n - History of liver cirrhosis with or without hepatitis viral co-infection.\n - Ongoing or clinically relevant pancreatitis.\n - 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.\n - 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.\n - 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.\n - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.\n - Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (<=325 mg per day) or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease.\n - Corrected QT interval (QTc (Bazett)) >450 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).\n - Alanine aminotransferase (ALT) >=5 × ULN or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin) over the last 6 months.\n - Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.\n - Participant has estimated creatinine clearance <50 mL/min/1.73m2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey, 2009).\nConcomitant Medications\n - 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;\n - Treatment with any of the following agents within 28 days of Day 1:\n•\tradiation therapy;\n•\tcytotoxic chemotherapeutic agents;\n•\ttuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]);\n•\tanti-coagulation agents;\n•\tImmunomodulators 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.\n - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.\n - Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility. (See SPM for a list of relevant medications)\n - Participants 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.","detailed_description":"","display_gender":"Female","display_gender_internal":"GENDER_FEMALE","display_phase":"Phase 3","display_phase_internal":"PHASE_3","display_status":"Not yet recruiting","display_status_internal":"RECSTATUS_I_NOT_YET_REC","endpoint":"","enrollment":"135","exclusion":"","gender":"Female","gender_based":"Yes","gender_description":"","healthy_volunteers":"No","id":"3d08f018-6724-5c5e-be44-10c1dce04cab","internal":{"content":null,"contentDigest":"3ce9e0a31d570d83fe876a97a6165390","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - Be able to understand and comply with protocol requirements, instructions, and restrictions;\n - Understand the long-term commitment to the study and be likely to complete the study as planned;\n - 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.).\nAll Participants eligible for enrolment in the study must meet all of the following criteria:\nAGE\n - Aged 18 years or older at the time of signing the informed consent.\nTYPE OF PARTICIPANT AND DIAGNOSIS INCLUDING DISEASE SEVERITY\n - 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).\nAcceptable stable antiretroviral (ARV) regimens prior to Screening include 2 Non-nucleoside reverse transcriptase inhibitors (NRTIs) plus:\n•\tIntegrase inhibitor (INI) (either the initial or second Combination antiretroviral therapy (cART) regimen)\n•\tNon-nucleoside reverse transcriptase inhibitor (NNRTI) (either the initial or second cART regimen)\n•\tBoosted 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) \n•\tAny suppressed participants on a triple ART regimen for at least 6 months who had their regimen switched to a 2DR of DTG/RPV\n - 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;\n - Plasma HIV-1 RNA <50 c/mL at Screening;\nSEX\n - A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at Day 1), not lactating, and at least one of the following conditions applies:\na. Non-reproductive potential defined as:\n•\tPre-menopausal females with one of the following:\no\tDocumented tubal ligation\no\tDocumented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion\no\tHysterectomy\no\tDocumented Bilateral Oophorectomy\n•\tPostmenopausal 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.\nb. 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.\n INFORMED CONSENT\n - 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.\n\nExclusion Criteria:\n HIV-1 RNA\n - Within 6 months prior to Screening, plasma HIV-1 RNA measurement >=50 c/mL;\n - During the previous 12 months, any confirmed HIV-1 RNA measurement >=200 c/mL Exclusionary medical conditions\n - Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study\n - 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 CD4+ counts <200 cells/microliter are not exclusionary\n - 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.\n - 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.\n - 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.\n - The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.\n - 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 DNA as follows:\n•\tParticipants positive for HBsAg are excluded;\n•\tParticipants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded\nNote: 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.\n - 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 DAA based therapy being considered with the medical monitor).\n - Participants with HCV co-infection will be allowed entry into this study if:\n•\tLiver enzymes meet entry criteria\n•\tHCV 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.\n•\tIn the event that recent biopsy or imaging data is not available or inconclusive, the Fib-4 score will be used to verify eligibility \no\tFib-4 score >3.25 is exclusionary\no\tFib-4 scores 1.45 – 3.25 requires Medical Monitor consultation\nFibrosis 4 Score Formula: (Age x AST) / (Platelets x ( sqr [ ALT ])\n - 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).\n - History of liver cirrhosis with or without hepatitis viral co-infection.\n - Ongoing or clinically relevant pancreatitis.\n - 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.\n - 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.\n - 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.\n - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.\n - Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (<=325 mg per day) or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease.\n - Corrected QT interval (QTc (Bazett)) >450 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).\n - Alanine aminotransferase (ALT) >=5 × ULN or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin) over the last 6 months.\n - Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening phase to verify a result.\n - Participant has estimated creatinine clearance <50 mL/min/1.73m2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Levey, 2009).\nConcomitant Medications\n - 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;\n - Treatment with any of the following agents within 28 days of Day 1:\n•\tradiation therapy;\n•\tcytotoxic chemotherapeutic agents;\n•\ttuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid [INH]);\n•\tanti-coagulation agents;\n•\tImmunomodulators 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.\n - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.\n - Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility. (See SPM for a list of relevant medications)\n - Participants 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.","interventions":[{"arm_group_label":"PLS UAT Testing","intervention_description":"PLS UAT Testing","intervention_name":"PLS UAT","intervention_type":"Other"}],"interventional_subtype":"Health Services Research","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Antiretroviral therapy, HIV infections, cabotegravir, rilpivirine, long-acting intramuscular injection,"],"last_follow_up_date":"08/12/2020 00:00:00","links":[],"locations":[{"City":"Atlanta","Latitude":"33.7971137","CountryDisplay":"United States","Longitude":"-84.3804888","Name":"GSK Investigational Site","StateDisplay":"Georgia","PostalCode":"30309","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Berkley","Latitude":"42.5007019","CountryDisplay":"United States","Longitude":"-83.1916937","Name":"GSK Investigational Site","StateDisplay":"Michigan","PostalCode":"48072","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Bronx","Latitude":"40.8723987","CountryDisplay":"United States","Longitude":"-73.8713099","Name":"GSK Investigational Site","StateDisplay":"New York","PostalCode":"10467","StatusDisplay":"Withdrawn","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Columbia","Latitude":"34.1156043","CountryDisplay":"United States","Longitude":"-81.0533854","Name":"GSK Investigational Site","StateDisplay":"South Carolina","PostalCode":"29203","StatusDisplay":"Withdrawn","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Dallas","Latitude":"32.7457134","CountryDisplay":"United States","Longitude":"-96.8458204","Name":"GSK Investigational Site","StateDisplay":"Texas","PostalCode":"75208","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Greensboro","Latitude":"36.0676041","CountryDisplay":"United States","Longitude":"-79.7568107","Name":"GSK Investigational Site","StateDisplay":"North Carolina","PostalCode":"27401-","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Jackson","Latitude":"32.3361632","CountryDisplay":"United States","Longitude":"-90.1565209","Name":"GSK Investigational Site","StateDisplay":"Mississippi","PostalCode":"39216-","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Jacksonville","Latitude":"30.3617348","CountryDisplay":"United States","Longitude":"-81.6966306","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"32209","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Kansas City","Latitude":"39.0587452","CountryDisplay":"United States","Longitude":"-94.5985613","Name":"GSK Investigational Site","StateDisplay":"Missouri","PostalCode":"64111","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Los Angeles","Latitude":"34.0664817","CountryDisplay":"United States","Longitude":"-118.3520389","Name":"GSK Investigational Site","StateDisplay":"California","PostalCode":"90036","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"Miami Beach","Latitude":"25.8176795","CountryDisplay":"United States","Longitude":"-80.1372757","Name":"GSK Investigational Site","StateDisplay":"Florida","PostalCode":"33140","StatusDisplay":"Not yet recruiting","StatusDisplayInternal":"LOCSTATUS_NOT_YET_REC","StatusMapped":"Will Be Recruiting"},{"City":"New Orleans","Latitude":"29.9682679","CountryDisplay":"United States","Longitude":"-90.0326531","Name":"GSK Investigational Site","StateDisplay":"Louisiana","PostalCode":"70117","StatusDisplay":"Withdrawn","StatusDisplayInternal":"LOCSTATUS_TERMINATED","StatusMapped":"Terminated/Withdrawn"},{"City":"Orlando","Latitude":"28.5542151","CountryDisplay":"United States","Longitude":"-81.3454417","Name":"GSK Investigational 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