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Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)- Positive Subjects From the LATTE Study

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ClinicalTrials.gov Identifier: NCT03639311
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral (ART) experienced subjects. Subjects will rollover from the NCT01641809(LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (<50 copies (c) per milliliter [mL]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The subjects will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval). Duration of study will vary from country to country, until regiment receives regulatory approval and becomes commercially available. The study plans to enroll approximately 100 subjects. Any subject who receives at least one dose of CAB LA and/or RPV LA and discontinues the CAB LA plus RPV LA regimen for any reason will enter a 52-week Long-Term Follow-Up (LTFU) phase. Those subjects must remain on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and or RPV LA.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: CAB LA Drug: RPV LA Drug: RPV Drug: DTG Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an Intervention Model, with parallel assignment, where the primary purpose of the study is, treatment, with 2 arms and no masking.
Masking: None (Open Label)
Masking Description: This is an open-label study, thus no masking.
Primary Purpose: Treatment
Official Title: A Phase IIb, Multicenter, Open-label, Rollover Study Evaluating the Efficacy, Safety and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months in HIV-1 Infected Adults Who Are Virologically Suppressed and Participated in Study LAI116482
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : January 13, 2020
Estimated Study Completion Date : January 11, 2021

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Subjects receiving Injection CAB LA plus RPV LA
The eligible subjects in the arm (subjects from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections will be administered 1 month after initial loading dose (CAB LA 600 mg plus RPV LA 900 mg), with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Subjects will continue to receive the treatment until the study intervention is locally approved and commercially available. HAART therapy will be initiated within 8 weeks after the last Q2M injection.
Drug: CAB LA
Administered CAB LA (600 mg) Q2M, intravenously.

Drug: RPV LA
Administered RPV LA (900 mg), Q2M, intravenously.

Experimental: Subjects receiving Oral DTG plus RPV
The eligible subjects in the arm (subjects from LATTE, who were administered oral CAB 30 mg plus RPV 25 mg, who successfully complete Week 300) will receive their first dose of the DTG 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Subjects will continue to receive the treatment until the study intervention is locally approved and commercially available.
Drug: RPV
Oral dose of RPV 25 mg, administered once daily from Day 1 up to Month 12

Drug: DTG
Oral dose of DTG 50 mg administered once daily from Day 1 up to Month 12.




Primary Outcome Measures :
  1. Number of subjects with HIV-RNA >=50 c per mL as per food and drug administration (FDA) Snapshot algorithm at Month 12 [ Time Frame: Month 12 ]
    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.


Secondary Outcome Measures :
  1. Number of subjects with plasma HIV-1 RNA <50 c/mL (c/mL) at Month 12 using the FDA Snapshot algorithm [ Time Frame: At Month 12 ]
    Plasma samples will be collected from the subject at specific timepoints. The Abbott RealTime HIV-1 Assay with LLOD 40 c/mL, will be used.

  2. Number of subjects with protocol defined confirmed virologic failure (CVF) over time [ Time Frame: Up to 40 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.

  3. Number of subjects with HIV-RNA greater than or equal to 50 c/mL as per FDA Snapshot algorithm over time [ Time Frame: Up to 40 months ]
    Plasma samples will be collected from the subject at specific time points. The Abbott RealTime HIV-1 Assay with LLOD 40 c/mL, will be used.

  4. Absolute values of HIV- viral load over time [ Time Frame: Up to 40 months ]
    Plasma samples will be collected at specific time points. This will measure the number of viral particles present in the plasma.

  5. Absolute values of cluster of differentiation 4 (CD4+) cell counts over time [ Time Frame: Up to 40 months ]
    Plasma samples will be collected at specific time points. The CD4+ cells is a glycoprotein found on the surface of immune cells such as the T-helper cells, monocytes, macrophages.

  6. Change from Baseline in HIV viral load over time [ Time Frame: Baseline and Up to 40 months ]
    Plasma samples will be collected at specific time points. This will measure the number of viral particles present in the plasma. Change from Baseline was defined as the post-Baseline value minus the value at Baseline.

  7. Change from Baseline in CD4+ cell count over time [ Time Frame: Baseline and Up to 40 months ]
    Plasma samples will be collected at specific time points. The CD4+ cells is a glycoprotein found on the surface of immune cells such as the T-helper cells, monocytes, macrophages. Change from Baseline was defined as the post-Baseline value minus the value at Baseline.

  8. Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 40 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. 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

  9. Number of subjects who discontinue treatment due to AEs over time. [ Time Frame: Up to 40 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.

  10. Number of subjects with abnormal hematology findings [ Time Frame: Up to 40 months ]
    Blood samples will be collected to measure platelets, white blood cell (WBC count), red blood cell (RBC) count, reticulocyte count, hemoglobin, hematocrit, RBC indices, mean corpuscular volume (MCV), basophils, eosinophils, lymphocytes, monocytes and neutrophils.

  11. Number of subjects with abnormal clinical chemistry findings [ Time Frame: Up to 40 months ]
    Blood samples will be collected to measure blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, potassium, chloride, Total carbon dioxide (CO2), lipase, phosphorous, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CK), creatinine clearance, albumin.

  12. Number of subjects with abnormal lipid findings [ Time Frame: Up to 40 months ]
    Subjects will be advised to do overnight fasting and then samples will be assessed for abnormal Total cholesterol, High density lipoprotein (HDL) cholesterol , Low density lipoprotein (LDL) cholesterol, and triglycerides.

  13. Change from Baseline in hematology parameters of platelets, WBC count, basophils, eosinophils, lymphocytes, monocytes and neutrophils [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure platelets, WBC count, basophils, eosinophils, lymphocytes, monocytes and neutrophils.

  14. Change from Baseline in hematology parameters of RBC count [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure RBC count .

  15. Change from Baseline in hematology parameters- Hemoglobin [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure Hemoglobin.

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

  17. Change from Baseline in clinical laboratory parameters of sodium, potassium, carbon-dioxide (total), chloride, and glucose [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure sodium, potassium, carbon-dioxide (total), chloride, and glucose.

  18. Change from Baseline in clinical laboratory parameters of creatinine and total bilirubin [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure creatinine and total bilirubin .

  19. Change from Baseline in clinical laboratory parameters of ALT, ALP and AST [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure ALT, ALP and AST

  20. Change from Baseline in clinical laboratory parameters of Creatine phosphokinase [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure Creatine phosphokinase.

  21. Change from Baseline in clinical laboratory parameters of Creatinine clearance [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure Creatinine clearance

  22. Change from Baseline in clinical laboratory parameters of lipase [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure lipase.

  23. Change from Baseline in urinalysis parameters, urine albumin to creatinine ratio [ Time Frame: Baseline and Up to 40 months ]
    Urine samples will be collected at the specified timepoints, for assessment of urine albumin to creatinine ratio.

  24. Change from Baseline in urinalysis parameters, urine protein to creatinine ratio [ Time Frame: Baseline and Up to 40 months ]
    Urine samples will be collected at the specified timepoints, for assessment of urine protein to creatinine ratio

  25. Change from Baseline in urinalysis parameters, urine phosphate [ Time Frame: Baseline and Up to 40 months ]
    Urine samples will be collected at the specified timepoints, for assessment of urine phosphate

  26. Change from Baseline in fasting lipid parameters: Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides [ Time Frame: Baseline and Up to 40 months ]
    Blood samples will be collected to measure, the change from Baseline values for Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides

  27. Number of subjects with treatment emergent genotypic resistance for CAB, RPV, and DTG plus RPV [ Time Frame: Up to 40 months ]
    Whole venous blood samples will be obtained from each subject to provide peripheral blood mononuclear cells (PBMCs) and plasma for storage samples. Analysis will be done to conduct for protease (PRO), reverse transcriptase (RT), and integrase assays.

  28. Trough concentrations (Ctrough) for CAB LA [ Time Frame: Pre-dose: Day 1 and Month 12 ]
    Serial blood samples will be collected at specific timepoints for PK analysis.

  29. Number of subjects with treatment emergent phenotypic resistance for CAB, RPV, and DTG plus RPV [ Time Frame: Up to 40 months ]
    Whole venous blood samples will be obtained from each subject to provide PBMCs and plasma for storage samples. Analysis will be done to conduct for PRO, RT, and integrase assays.

  30. Ctrough for RPV LA [ Time Frame: Pre-dose: Day 1 and Month 12 ]
    Serial blood samples will be collected at specific timepoints for PK analysis.

  31. Change from Baseline (Day 1) in HIV Dependent Quality of Life (HIVDQoL) [ Time Frame: Baseline and Up to Month12 ]
    The HIVDQoL is an individualized, self-completion questionnaire, specifically designed to measure quality of life in people living with HIV. The HIVDQoL was based on Audit of Diabetes-Dependent Quality of Life (ADDQoL) -a widely used questionnaire designed for diabetics and linguistically validated in more than 60 languages. The HIVDQoL includes two overview items, 26 condition-specific domain items and a free text box. The overview items ask subjects to rate their generic 'present QoL' (7-point Likert scale, ranging from 3 [excellent] to -3 [extremely bad]) and HIV-specific 'impact of HIV on QoL' (5-point Likert scale, ranging from 3 [very much better] to 1 [worse]). The "Preference" question will contain a single item exploring whether subjects prefer the CAB LA + RPV LA injectable to the oral CAB + RPV regimen administered in LATTE. The "Reason for Switch" question will contain a single item exploring the reasons why subjects are interested in switching to the CAB LA + RPV LA.

  32. Change from baseline (Day 1) in HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) [ Time Frame: Baseline and Up to Month12 ]
    The HIVTSQ is a 10-item self-reported scale which will measure the overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The items will be summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Change from Baseline was defined as the post-Baseline value minus the value at Baseline.

  33. Change in treatment satisfaction over time using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) [ Time Frame: Baseline and Up to Month12 ]
    HIVTSQc is 12-item questionnaire, which retains option of calculating the total score as if it only had the original 10 items (as the original 10 items are included in the HIVTSQ 12). In addition, it allows for calculation of an 11-item scale score including the "easy/difficult" item (item-11). The "pain/discomfort" item (item-12) will be included in questionnaire as a stand-alone item to evaluate potentially painful injectables. Overall satisfaction with treatment and by specific domains e.g. convenience, flexibility is assessed. The items are summed up to produce treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. Higher the score, greater the improvement in treatment satisfaction as compared to the past few weeks. Change from Baseline was defined as the post-Baseline value minus the value at Baseline.



Information from the National Library of Medicine

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


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

Inclusion Criteria:

  • Aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.
  • A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test at Day 1), not lactating, and at least with one of following conditions.
  • 1.Non-reproductive potential defined as, Pre-menopausal females with one of the following conditions as 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.
  • 2.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, 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 subjects understand how to properly use the methods of contraception.
  • Capable of giving signed informed consent.
  • Must have been on oral CAB 30 mg plus RPV 25 mg regimen through at minimum Week 300 of the LATTE study as per LATTE protocol dosing requirements and until Day 1 of the POLAR study. Any disruptions in dosing during LATTE must be discussed with the Medical Monitor for a final determination of eligibility.
  • Plasma HIV-1 RNA <50 c/mL at Week 300. If subject has plasma HIV-1 RNA >= 50 c/mL at Week 300 in LATTE, a single repeat to determine eligibility may be allowed ONLY after consultation with the medical monitor.

Exclusion Criteria:

  • During the last 6 months of participation in LATTE, consecutive (2 or more sequential) plasma HIV-1 RNA measurements >=50 c/mL.
  • During the last 6 months of participation in LATTE, any HIV-1 RNA measurement >=200 c/mL.
  • 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.
  • Subjects with moderate to severe hepatic impairment determined by Child-Pugh classification.
  • Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject.
  • Subjects determined by the Investigator to have a high risk of seizures, including subjects with an unstable or poorly controlled seizure disorder. A subject with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low.
  • Subjects who, in the investigator's judgment, pose a significant suicide risk. Subject's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
  • Subject 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 DNA as follows; Subjects positive for HBsAg are excluded; subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
  • Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; subjects who are anticipated to require HCV treatment within 12 months must be excluded. (HCV treatment on study may be permitted, following consultation with the medical monitor).
  • Subjects 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 subjects, 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 fibrosis- 4 (Fib-4) score will be used to verify eligibility where Fib-4 score >3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation where the Fibrosis 4 Score Formula: age multiplied by aspartate amino transferase (AST) divided by platelets multiplied by square of alanine aminotransferase (ALT).
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • History of liver cirrhosis with or without hepatitis viral co-infection.
  • Ongoing or clinically relevant pancreatitis.
  • Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomization.
  • 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 subject unable to receive study medication.
  • History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
  • Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (<=325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
  • Corrected QT interval (QTc (Bazett)) >450 millisecond (msec) or QTc (Bazett) >480 msec for subjects with bundle branch block.
  • Any verified Grade 4 laboratory abnormality over the last 6 months in LATTE. A single repeat test is allowed to verify a result.
  • Any acute laboratory abnormality over the last 6 months in LATTE, which, in the opinion of the investigator, would preclude the subject's participation in the study of an investigational compound.
  • ALT>=5 times upper limit of normal (ULN) or ALT >= 3 times ULN and bilirubin >= 1.5xULN (with >35% direct bilirubin) over the last 6 months in LATTE.
  • Exposure to an experimental drug (with the exception of those in the LATTE study including CAB and RPV) or experimental vaccine within either 30 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: Subjects using short-term (e.g. <=21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment.
  • 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. Any prohibited medications that decrease CAB, RPV and/or DTG 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): NCT03639311


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

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Sponsors and Collaborators
ViiV Healthcare
Janssen, LP
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03639311     History of Changes
Other Study ID Numbers: 209035
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 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:
HIV
ART
maintenance
Long acting
LATTE

Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus 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