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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":"NCT02478463","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":"true"},"PatientLevelData":"false","SharingIpd":"None","acronym":"","allocation":"N/A","arm_groups":[{"arm_group_label":"Cabotegravir","arm_group_description":"Subject will receive CAB 30 mg tablet once daily oral dose for 28 days (4 weeks) followed by a washout period of 14 to 42 days. After the washout, subject will receive a single dose of CAB LA 600 mg IM to gluteal region.","arm_type":"Experimental"}],"assignment":"Single Group Assignment","brief_summary":"Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical sites associated with sexual HIV transmission following the proposed 600 milligram (mg) intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1 transmission and supplement the data to support future PrEP clinical trial development. The primary objective is to determine the PK concentrations of CAB following LA administration in plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations associated with sexual HIV-1 transmission: VT, CT, CVF, RT and RF. The study will consist of a screening period, a 28-day oral lead-in phase at a dose of 30 mg per day followed by a 14-42 day washout period, and a single dose of CAB LA 600 mg as an IM (intragluteal) injection with compartmental pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will return for safety assessments and plasma PK sampling at Week 24 and Week 36 post-injection and undergo a follow-up/withdrawal visit at Week 52 post-injection.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:28:33","criteria":"Inclusion Criteria: - Between 18 and 55 years of age inclusive, at the time of signing the informed consent. - Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the medical monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility. - Body weight >= 40 kilogram (kg) and body mass index (BMI) within the range 18.5 to 35 kg /meter square (inclusive). - Male or female - A female subject is eligible to participate if she is pre-menopausal, has an intact uterus and cervix, AND is not pregnant (as confirmed by a negative human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: a) 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, Documented Bilateral Oophorectomy. b)Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer (can be up to 66 weeks on study) after the last dose of study medication and completion of the follow-up visit. Female subjects desiring pregnancy or foresee that they might wish to become pregnant within 52 weeks of receiving a CAB LA injection must be excluded. All subjects participating in the study must be counseled on safe sexual practices including the use of effective barrier methods to minimize risk of HIV transmission. - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Exclusion Criteria: - Liver Function: ALT or AST > upper limit of normal (ULN) - Total bilirubin >ULN (isolated total bilirubin >ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%) - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). - Corrected QT (QTc) Interval: QTc > 450 milliseconds (msec): NOTES: The QTc is the QT interval corrected for heart rate according to Bazette’s formula (QTcB), machine-read or manually over-read. QTcB will be used to determine eligibility for an individual subject. Exclusion criteria for screening electrocardiogram (ECG) (a single repeat is allowed for eligibility determination): Heart rate (<45 and >100 beats per minute (bpm) for males and <50 and >100 bpm for females; QRS duration: >120 msec; QTc interval: >450 msec for males and females - The subject’s systolic blood pressure is outside the range of 90-140 millimeter (mm) mercury (Hg), or diastolic blood pressure is outside the range of 45–90 mmHg. - History of clinically significant cardiovascular disease including: Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization); History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease; Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block (2nd degree [type II] or higher), Wolf Parkinson White [WPW] syndrome); Sinus pauses > 3 seconds. - Any significant arrhythmia which, in the opinion of the principal Investigator and GSK Medical Monitor, will interfere with the safety for the individual subject. Non-sustained (>=3 consecutive ventricular ectopic beats) or sustained ventricular tachycardia. - History of ongoing or clinically relevant seizure disorder within the previous 2 years, including subjects who have required treatment for seizures within this time period. A prior history of seizure, with a seizure free period of at least 2 years, off anti-epileptics, may be considered for enrolment if the investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the medical monitor prior to enrolment - Use of any concurrent prohibited medications as outlined in protocol - History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. - Inability or unwillingness to comply with lifestyle and/or dietary restrictions outlined in protocol. - High-risk behavior for HIV infection which includes, but is not limited to, one of the following risk factors within six months before entering the study (Day 1 of the oral lead-in): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months or intravenous drug use. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. - For subjects participating in magnetic resonance imaging (MRI) imaging: Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other non-MRI compatible metallic objects; b) Intra- orbital metal fragments that have not been removed by a medical professional; c) Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves, d) Inner ear implants, e) History of claustrophobia - Positive hepatitis B surface antigen or positive hepatitis B core antibody with negative hepatitis B surface antibody test result at screening or within 3 months prior to first dose of study treatment. - Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment - A positive pre-study drug/alcohol screen. A positive drug screen is permitted if due to a prescribed medication, provided that medication is not on the list of prohibited medications and approved by the investigator and medical monitor. - A positive test for HIV antibody. - A positive pre-study screen for sexually transmitted diseases including Neisseria gonorrhea or Chlamydia trachomatis, Trichomonas, syphilis, or an active Herpes simplex virus (HSV) genital lesion. - Presence of a tattoo or other dermatological condition overlying the buttocks which in the opinion of the investigator may interfere with the interpretation of injection site reactions. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. - Unwillingness or inability to follow the procedures outlined in the protocol. - Subject is mentally or legally incapacitated. Additional Criteria for Female Subjects Only: - Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the genital tract sampling (e.g., active genital tract infection or lesions). - Inability to abstain from the use of intravaginal products (e.g. tampons, spermicides, lubricants, vaginal hygiene products, diaphragms) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after. - Inability to abstain from any sexual activity (e.g., vaginal intercourse, masturbation, and penetration of the vagina by penises, fingers, tampons, sex toys) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after. Additional Criteria for Male Subjects and Female Subjects who consent to rectal PK sampling: - Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the rectal compartment sampling (e.g., active rectal compartment infection, lesions or disease). - Inability to abstain from the use of intrarectal products (e.g., suppositories, lubricants) for 72 hours prior to the rectal compartment sample collection visits and for up to 72 hours after. - Inability to abstain from any receptive anal sexual activity (e.g., anal receptive intercourse and penetration of the rectum by fingers, sex toys or other) for 72 hours prior to the rectal compartment sample collection visit and for up to 72 hours after.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 1","display_phase_internal":"PHASE_1","display_status":"Recruiting","display_status_internal":"RECSTATUS_RECRUITING","endpoint":"","enrollment":"16","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"Yes","id":"edfdd5d2-b216-52d3-a35d-edba7cbce46e","internal":{"content":null,"contentDigest":"b991f672b2f77f7c7486fbc1ade9ad20","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Between 18 and 55 years of age inclusive, at the time of signing the informed consent. - Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the medical monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility. - Body weight >= 40 kilogram (kg) and body mass index (BMI) within the range 18.5 to 35 kg /meter square (inclusive). - Male or female - A female subject is eligible to participate if she is pre-menopausal, has an intact uterus and cervix, AND is not pregnant (as confirmed by a negative human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: a) 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, Documented Bilateral Oophorectomy. b)Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer (can be up to 66 weeks on study) after the last dose of study medication and completion of the follow-up visit. Female subjects desiring pregnancy or foresee that they might wish to become pregnant within 52 weeks of receiving a CAB LA injection must be excluded. All subjects participating in the study must be counseled on safe sexual practices including the use of effective barrier methods to minimize risk of HIV transmission. - Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Exclusion Criteria: - Liver Function: ALT or AST > upper limit of normal (ULN) - Total bilirubin >ULN (isolated total bilirubin >ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%) - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). - Corrected QT (QTc) Interval: QTc > 450 milliseconds (msec): NOTES: The QTc is the QT interval corrected for heart rate according to Bazette’s formula (QTcB), machine-read or manually over-read. QTcB will be used to determine eligibility for an individual subject. Exclusion criteria for screening electrocardiogram (ECG) (a single repeat is allowed for eligibility determination): Heart rate (<45 and >100 beats per minute (bpm) for males and <50 and >100 bpm for females; QRS duration: >120 msec; QTc interval: >450 msec for males and females - The subject’s systolic blood pressure is outside the range of 90-140 millimeter (mm) mercury (Hg), or diastolic blood pressure is outside the range of 45–90 mmHg. - History of clinically significant cardiovascular disease including: Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization); History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease; Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block (2nd degree [type II] or higher), Wolf Parkinson White [WPW] syndrome); Sinus pauses > 3 seconds. - Any significant arrhythmia which, in the opinion of the principal Investigator and GSK Medical Monitor, will interfere with the safety for the individual subject. Non-sustained (>=3 consecutive ventricular ectopic beats) or sustained ventricular tachycardia. - History of ongoing or clinically relevant seizure disorder within the previous 2 years, including subjects who have required treatment for seizures within this time period. A prior history of seizure, with a seizure free period of at least 2 years, off anti-epileptics, may be considered for enrolment if the investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the medical monitor prior to enrolment - Use of any concurrent prohibited medications as outlined in protocol - History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits. - Inability or unwillingness to comply with lifestyle and/or dietary restrictions outlined in protocol. - High-risk behavior for HIV infection which includes, but is not limited to, one of the following risk factors within six months before entering the study (Day 1 of the oral lead-in): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months or intravenous drug use. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. - For subjects participating in magnetic resonance imaging (MRI) imaging: Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other non-MRI compatible metallic objects; b) Intra- orbital metal fragments that have not been removed by a medical professional; c) Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves, d) Inner ear implants, e) History of claustrophobia - Positive hepatitis B surface antigen or positive hepatitis B core antibody with negative hepatitis B surface antibody test result at screening or within 3 months prior to first dose of study treatment. - Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment - A positive pre-study drug/alcohol screen. A positive drug screen is permitted if due to a prescribed medication, provided that medication is not on the list of prohibited medications and approved by the investigator and medical monitor. - A positive test for HIV antibody. - A positive pre-study screen for sexually transmitted diseases including Neisseria gonorrhea or Chlamydia trachomatis, Trichomonas, syphilis, or an active Herpes simplex virus (HSV) genital lesion. - Presence of a tattoo or other dermatological condition overlying the buttocks which in the opinion of the investigator may interfere with the interpretation of injection site reactions. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Exposure to more than four new chemical entities within 12 months prior to the first dosing day. - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. - Unwillingness or inability to follow the procedures outlined in the protocol. - Subject is mentally or legally incapacitated. Additional Criteria for Female Subjects Only: - Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the genital tract sampling (e.g., active genital tract infection or lesions). - Inability to abstain from the use of intravaginal products (e.g. tampons, spermicides, lubricants, vaginal hygiene products, diaphragms) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after. - Inability to abstain from any sexual activity (e.g., vaginal intercourse, masturbation, and penetration of the vagina by penises, fingers, tampons, sex toys) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after. Additional Criteria for Male Subjects and Female Subjects who consent to rectal PK sampling: - Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the rectal compartment sampling (e.g., active rectal compartment infection, lesions or disease). - Inability to abstain from the use of intrarectal products (e.g., suppositories, lubricants) for 72 hours prior to the rectal compartment sample collection visits and for up to 72 hours after. - Inability to abstain from any receptive anal sexual activity (e.g., anal receptive intercourse and penetration of the rectum by fingers, sex toys or other) for 72 hours prior to the rectal compartment sample collection visit and for up to 72 hours after.","interventions":[{"arm_group_label":"Cabotegravir","intervention_description":"GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237","intervention_name":"Cabotegravir tablet 30 mg once daily for 28 days.","intervention_type":"Drug"},{"arm_group_label":"Cabotegravir","intervention_description":"Cabotegravir will be supplied as sterile suspension for injection 200 mg/mL vial. Each vial appears as sterile white to slightly colored suspension containing 200 mg/mL of CAB for administration by intramuscular (intragluteal) injection and will be administered as 1 × 3 mL Injections (3 mL [600 mg] total) IM given once on Day 1 of injection phase","intervention_name":"Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":["Cabotegravir","Pharmacokinetic","Healthy Adult Volunteers","GSK1265744"],"last_follow_up_date":"09/10/2019 00:00:00","links":[],"locations":[{"City":"Baltimore","Latitude":"39.2903848","CountryDisplay":"United States","Longitude":"-76.6121893","Name":"GSK Investigational Site","StateDisplay":"Maryland","PostalCode":"21287-5554","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"},{"City":"Pittsburgh","Latitude":"40.4379259","CountryDisplay":"United States","Longitude":"-79.9556424","Name":"GSK Investigational Site","StateDisplay":"Pennsylvania","PostalCode":"15213","StatusDisplay":"Recruiting","StatusDisplayInternal":"LOCSTATUS_RECRUITING","StatusMapped":"Recruiting"}],"masking":"","maximum_age_raw":"55 years","maximum_age":"55","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"10/01/2018 22:37:25","number_of_arms":"1","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"official_title":"A Phase 1, Multicompartmental Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers","org_study_id":"201767","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Recruiting - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"No","fda_regulated_drug":"Yes","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"1","primary_compl_date":"09/10/2019 00:00:00","primary_outcomes":[{"outcome_description":"Blood samples will be collected from male and female subjects at the indicated time points after administration of a single CAB 600 mg intramuscular dose.","outcome_measure":"CAB CONCENTRATION IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8, Weeks 4, 8, 12, 24, 36 and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"VT sample will be collected only on Day 3 (48 hour) and Week 8 in female subjects following a single CAB 600 mg intramuscular dose.","outcome_measure":"CAB CONCENTRATION IN VT","outcome_time_frame":"Day 3 and Week 8 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CT sample will be collected from female subjects at the indicated time points following a single CAB 600 mg intramuscular dose.","outcome_measure":"CAB CONCENTRATION IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF sample will be collected from female subjects at the indicated time points following a single CAB 600 mg intramuscular dose.","outcome_measure":"CAB CONCENTRATION IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT samples will be collected from male and female subjects at the indicated time points following a single CAB 600 mg intramuscular dose.","outcome_measure":"CAB CONCENTRATION IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF samples will be collected from male and female subjects at the indicated time points following a single CAB 600 mg intramuscular dose.","outcome_measure":"CAB CONCENTRATION IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"The concentration of CAB in VT relative to blood plasma following a single IM dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIOS OF VT VERSUS (VS) BLOOD PLASMA","outcome_time_frame":"Day 3 and Week 8 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The concentration of CAB in CT relative to blood plasma following a single IM dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIO OF CT VS BLOOD PLASMA","outcome_time_frame":"Day 3, Day 8 and Weeks 4, 8 and 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The concentration of CAB in CVF relative to blood plasma following a single IM dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIO OF CVF VS BLOOD PLASMA","outcome_time_frame":"Day 3, Day 8 and Weeks 4, 8 and 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The concentration of CAB in CT relative to CVF following a single IM dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIO OF CT VS CVF","outcome_time_frame":"Day 3, Day 8 and Weeks 4, 8 and 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The concentration of CAB in VT relative to CVF following a single IM dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIO OF VT VS CVF","outcome_time_frame":"Day 3 and Week 8 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The concentration of CAB in RT relative to blood plasma following a single IM dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIO OF RT VS BLOOD PLASMA","outcome_time_frame":"Day 3, Day 8 and Weeks 4, 8 and 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The concentration of CAB in RF relative to blood plasma following a single intramuscular dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIO OF RF VS BLOOD PLASMA","outcome_time_frame":"Day 3, Day 8 and Weeks 4, 8 and 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The concentration of CAB in RT relative to RF following a single intramuscular dose of CAB 600 mg will be evaluated.","outcome_measure":"CONCENTRATION RATIO OF RT VS RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected at the indicated time points.","outcome_measure":"MAXIMUM OBSERVED CONCENTRATION (CMAX) OF CAB IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8 and Weeks 4, 8, 12, 24, 36, and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CT biopsy samples will be collected at the indicated time points","outcome_measure":"CMAX OF CAB IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"CMAX OF CAB IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT biopsy samples will be collected at the indicated time points","outcome_measure":"CMAX OF CAB IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF will be collected at the indicated time points","outcome_measure":"CMAX OF CAB IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected at the indicated time points","outcome_measure":"AREA UNDER THE CONCENTRATION TIME CURVE FROM TIME ZERO TO LAST QUANTIFIABLE TIME POINT (AUC(0-LAST)) IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8 and Weeks 4, 8, 12, 24, 36, and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-LAST) IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"AUC(0-LAST) IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-LAST) IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF will be collected at the indicated time points","outcome_measure":"AUC(0-LAST) IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected at the indicated time points","outcome_measure":"AREA UNDER THE CONCENTRATION TIME CURVE FROM TIME ZERO TO INFINITY (AUC(0-INF)) IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8 and Weeks 4, 8, 12, 24, 36, and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-INF) IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"AUC(0-INF) IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-INF) IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF will be collected at the indicated time points","outcome_measure":"AUC(0-INF) IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected at the indicated time points","outcome_measure":"AREA UNDER THE CONCENTRATION TIME CURVE FROM TIME ZERO TO WEEK 4 (AUC(0-WK4)) IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8 and Weeks 4, 8, 12, 24, 36, and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-WK4) IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"AUC(0-WK4) IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-WK4) IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF will be collected at the indicated time points","outcome_measure":"AUC(0-WK4) IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected at the indicated time points","outcome_measure":"AREA UNDER THE CONCENTRATION TIME CURVE FROM TIME ZERO TO WEEK 8 (AUC(0-WK8) IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8 and Weeks 4, 8, 12, 24, 36, and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-WK8) IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"AUC(0-WK8) IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-WK8) IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF will be collected at the indicated time points","outcome_measure":"AUC(0-WK8) IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected at the indicated time points","outcome_measure":"AREA UNDER THE CONCENTRATION TIME CURVE FROM TIME ZERO TO WEEK 12 (AUC(0-WK12)) IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8 and Weeks 4, 8, 12, 24, 36, and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-WK12) IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"AUC(0-WK12) IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT biopsy samples will be collected at the indicated time points","outcome_measure":"AUC(0-WK12) IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF will be collected at the indicated time points","outcome_measure":"AUC(0-WK12) IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"Blood samples will be collected at the indicated time points","outcome_measure":"APPARENT TERMINAL PHASE HALF-LIFE (T1/2) IN BLOOD PLASMA","outcome_time_frame":"Predose, Day 1 (4 hour), Day 3, Day 5, Day 8 and Weeks 4, 8, 12, 24, 36, and 52 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"T1/2 IN CT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"CVF will be collected at the indicated time points","outcome_measure":"T1/2 IN CVF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RT biopsy samples will be collected at the indicated time points","outcome_measure":"T1/2 IN RT","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"RF will be collected at the indicated time points","outcome_measure":"T1/2 IN RF","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in tissue and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"TISSUE:BLOOD PLASMA RATIO OF AUC(0-LAST)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in tissue and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"TISSUE:BLOOD PLASMA RATIO OF AUC(0-INF)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in tissue and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"TISSUE:BLOOD PLASMA RATIO OF AUC(0-WK4)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in tissue and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"TISSUE:BLOOD PLASMA RATIO OF AUC(0-WK8)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in tissue and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"TISSUE:BLOOD PLASMA RATIO OF AUC(0-WK12)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in fluid and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"FLUID:BLOOD PLASMA RATIO OF AUC(0-LAST)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in fluid and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"FLUID:BLOOD PLASMA RATIO OF AUC(0-INF)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in fluid and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"FLUID:BLOOD PLASMA RATIO OF AUC(0-WK4)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in fluid and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"FLUID:BLOOD PLASMA RATIO OF AUC(0-WK8)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"The ratio of AUC in fluid and blood plasma matrices will be determined from concentration-time data.","outcome_measure":"FLUID:BLOOD PLASMA RATIO OF AUC(0-WK12)","outcome_time_frame":"Day 3, Day 8, Week 4, Week 8 and Week 12 post intramuscular dose","outcome_safety_issue":null},{"outcome_description":"VT biopsy sample will be collected on Day 29 to determine CAB concentration following administration of oral CAB 30 mg tablet once daily for 4 weeks in the oral lead-in phase.","outcome_measure":"CAB CONCENTRATION (C24) FOLLOWING ORAL ADMINISTRATION IN VT","outcome_time_frame":"Day 29","outcome_safety_issue":null},{"outcome_description":"CT biopsy sample will be collected on Day 29 to determine CAB concentration following administration of oral CAB 30 mg tablet once daily for 4 weeks in the oral lead-in phase.","outcome_measure":"C24 FOLLOWING ORAL ADMINISTRATION IN CT","outcome_time_frame":"Day 29","outcome_safety_issue":null},{"outcome_description":"CVF will be collected on Day 29 to determine CAB concentration following administration of oral CAB 30 mg tablet once daily for 4 weeks in the oral lead-in phase.","outcome_measure":"C24 FOLLOWING ORAL ADMINISTRATION IN CVF","outcome_time_frame":"Day 29","outcome_safety_issue":null},{"outcome_description":"RT biopsy sample will be collected on Day 29 to determine CAB concentration following administration of oral CAB 30 mg tablet once daily for 4 weeks in the oral lead-in phase.","outcome_measure":"C24 FOLLOWING ORAL ADMINISTRATION IN RT","outcome_time_frame":"Day 29","outcome_safety_issue":null},{"outcome_description":"RF will be collected on Day 29 to determine CAB concentration following administration of oral CAB 30 mg tablet once daily for 4 weeks in the oral lead-in phase.","outcome_measure":"C24 FOLLOWING ORAL ADMINISTRATION IN RF","outcome_time_frame":"Day 29","outcome_safety_issue":null},{"outcome_description":"Blood sample will be collected on Day 29 to determine CAB concentration following administration of oral CAB 30 mg tablet once daily for 4 weeks in the oral lead-in phase.","outcome_measure":"C24 FOLLOWING ORAL ADMINISTRATION IN BLOOD PLASMA","outcome_time_frame":"Day 29","outcome_safety_issue":null},{"outcome_description":"AEs and SAEs will be collected from the start of study Treatment until the follow-up contact.","outcome_measure":"NUMBER OF SUBJECTS WITH ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENT (SAE) FOLLOWING ORAL CAB DOSE","outcome_time_frame":"Up to Day 71","outcome_safety_issue":null},{"outcome_description":"AEs and SAEs will be collected from the start of study Treatment until the follow-up contact.","outcome_measure":"NUMBER OF SUBJECTS WITH AE AND SAE FOLLOWING IM CAB DOSE","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, calcium, magnesium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein, creatine phosphokinase and albumin.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL CLINICAL CHEMISTRY PARAMETERS FOLLOWING ORAL CAB DOSE","outcome_time_frame":"Up to Day 29","outcome_safety_issue":null},{"outcome_description":"The following clinical chemistry parameters will be evaluated: BUN, creatinine, glucose, potassium, sodium, calcium, magnesium, AST, ALT, alkaline phosphatase, total and direct bilirubin, total protein, creatine phosphokinase and albumin.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL CLINICAL CHEMISTRY PARAMETERS FOLLOWING IM CAB DOSE","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"The following hematology parameters will be evaluated: platelet count, red blood cell (RBC) count, Hemoglobin, Hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and immature band forms.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL HEMATOLOGY PARAMETERS FOLLOWING ORAL CAB DOSE","outcome_time_frame":"Up to Day 29","outcome_safety_issue":null},{"outcome_description":"The following hematology parameters will be evaluated: platelet count, RBC count, Hemoglobin, Hematocrit, MCV, MCH, MCHC, neutrophils, lymphocytes, monocytes, eosinophils, basophils and immature band forms.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL HEMATOLOGY PARAMETERS FOLLOWING IM CAB DOSE","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"The following urine parameters will be analyzed: specific gravity, hydrogen ion concentration (pH), glucose, protein, blood and ketones by dipstick, microscopic examination.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL URINE PARAMETERS FOLLOWING ORAL CAB DOSE","outcome_time_frame":"Up to Day 29","outcome_safety_issue":null},{"outcome_description":"The following urine parameters will be analyzed: specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL URINE PARAMETERS FOLLOWING IM CAB DOSE","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"Temperature will be measured in semi-supine position after 10 minutes rest.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL TEMPERATURE MEASUREMENTS FOLLOWING ORAL CAB DOSE","outcome_time_frame":"Up to Day 29","outcome_safety_issue":null},{"outcome_description":"Temperature will be measured in semi-supine position after 10 minutes rest.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL TEMPERATURE MEASUREMENTS FOLLOWING IM CAB DOSE","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"Systolic and diastolic blood pressure will be measured in semi-supine position after 10 minutes rest.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL BLOOD PRESSURE FOLLOWING ORAL CAB DOSE","outcome_time_frame":"Up to Day 29","outcome_safety_issue":null},{"outcome_description":"Systolic and diastolic blood pressure will be measured in semi-supine position after 10 minutes rest.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL BLOOD PRESSURE FOLLOWING IM CAB DOSE","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null},{"outcome_description":"Pulse rate will be measured in semi-supine position after 10 minutes rest.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL PULSE RATE FOLLOWING ORAL CAB DOSE","outcome_time_frame":"Up to Day 29","outcome_safety_issue":null},{"outcome_description":"Pulse rate will be measured in semi-supine position after 10 minutes rest.","outcome_measure":"NUMBER OF SUBJECTS WITH ABNORMAL PULSE RATE FOLLOWING IM CAB DOSE","outcome_time_frame":"Up to Week 52","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"02/27/2017 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":false}},"pageContext":{"studyId":"201767"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}