Active, not recruiting

Study Description:

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.

Viiv Study ID:

209035


Clinicaltrials.gov Identifier:

NCT03639311


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

GSK3365791;cabotegravir;dolutegravir;rilpivirine

Collaborators

Janssen


Date

August 2018 to January 2021

Type

Interventional

Phase

2


Gender

All

Age

18 years - N/A

Accepts Healthy Volunteers

No


Study Documents

No documents available
This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Canada, British Columbia, Vancouver V6Z 2T1Active, not recruiting
Canada, Ontario, Toronto M5G 1K2Active, not recruiting
Canada, Ontario, Toronto M4N 3M5Active, not recruiting
Canada, Québec, Montreal H3A 1T1Active, not recruiting
Canada, Québec, Montreal H2L 4E9Active, not recruiting
United States, Arizona, Phoenix 85015Active, not recruiting
United States, California, Bakersfield 93301Active, not recruiting
United States, California, Beverly Hills 90211Active, not recruiting
United States, California, Long Beach 90813Active, not recruiting
United States, California, Los Angeles 90069Active, not recruiting
United States, Colorado, Denver 80209Active, not recruiting
United States, District of Columbia, Washington 20037Active, not recruiting
United States, District of Columbia, Washington 20007Active, not recruiting
United States, Florida, Fort Lauderdale 33316Active, not recruiting
United States, Florida, Fort Pierce 34982Active, not recruiting
United States, Florida, Orlando 32803Active, not recruiting
United States, Florida, West Palm Beach 33407Active, not recruiting
United States, Georgia, Augusta 30912-3130Active, not recruiting
United States, Georgia, Macon 31201Active, not recruiting
United States, Georgia, Savannah 31401Active, not recruiting
United States, Indiana, Indianapolis 46202Active, not recruiting
United States, Nebraska, Omaha 68198Active, not recruiting
United States, Nevada, Las Vegas 89106Active, not recruiting
United States, New York, Buffalo 14215Active, not recruiting
United States, New York, New York 10032Active, not recruiting
United States, New York, New York 10065Completed
United States, South Carolina, Charleston 29425Active, not recruiting
United States, Texas, Austin 78705Active, not recruiting
United States, Texas, Dallas 75246Active, not recruiting
United States, Virginia, Annandale 22003Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Non-randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: This is an open-label study, thus no masking.
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Number of subjects with HIV-RNA >=50 c per mL as per food and drug administration (FDA) Snapshot algorithm at Month 12
    Timeframe: Month 12

Secondary Outcomes:

  • Number of subjects with plasma HIV-1 RNA <50 c/mL (c/mL) at Month 12 using the FDA Snapshot algorithm
    Timeframe: At Month 12

  • Number of subjects with protocol defined confirmed virologic failure (CVF) over time
    Timeframe: Up to 40 months

  • Number of subjects with HIV-RNA greater than or equal to 50 c/mL as per FDA Snapshot algorithm over time
    Timeframe: Up to 40 months

  • Absolute values of HIV- viral load over time
    Timeframe: Up to 40 months

  • Absolute values of cluster of differentiation 4 (CD4+) cell counts over time
    Timeframe: Up to 40 months

  • Change from Baseline in HIV viral load over time
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in CD4+ cell count over time
    Timeframe: Baseline and Up to 40 months

  • Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
    Timeframe: Up to 40 months

  • Number of subjects who discontinue treatment due to AEs over time.
    Timeframe: Up to 40 months

  • Number of subjects with abnormal hematology findings
    Timeframe: Up to 40 months

  • Number of subjects with abnormal clinical chemistry findings
    Timeframe: Up to 40 months

  • Number of subjects with abnormal lipid findings
    Timeframe: Up to 40 months

  • Change from Baseline in hematology parameters of platelets, WBC count, basophils, eosinophils, lymphocytes, monocytes and neutrophils
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in hematology parameters of RBC count
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in hematology parameters- Hemoglobin
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in hematology parameter of hematocrit
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in clinical laboratory parameters of sodium, potassium, carbon-dioxide (total), chloride, and glucose
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in clinical laboratory parameters of creatinine and total bilirubin
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in clinical laboratory parameters of ALT, ALP and AST
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in clinical laboratory parameters of Creatine phosphokinase
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in clinical laboratory parameters of Creatinine clearance
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in clinical laboratory parameters of lipase
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in urinalysis parameters, urine albumin to creatinine ratio
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in urinalysis parameters, urine protein to creatinine ratio
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in urinalysis parameters, urine phosphate
    Timeframe: Baseline and Up to 40 months

  • Change from Baseline in fasting lipid parameters: Total cholesterol, HDL cholesterol, LDL cholesterol, and Triglycerides
    Timeframe: Baseline and Up to 40 months

  • Number of subjects with treatment emergent genotypic resistance for CAB, RPV, and DTG plus RPV
    Timeframe: Up to 40 months

  • Trough concentrations (Ctrough) for CAB LA
    Timeframe: Pre-dose: Day 1 and Month 12

  • Number of subjects with treatment emergent phenotypic resistance for CAB, RPV, and DTG plus RPV
    Timeframe: Up to 40 months

  • Ctrough for RPV LA
    Timeframe: Pre-dose: Day 1 and Month 12

  • Change from Baseline (Day 1) in HIV Dependent Quality of Life (HIVDQoL)
    Timeframe: Baseline and Up to Month12

  • Change from baseline (Day 1) in HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
    Timeframe: Baseline and Up to Month12

  • Change in treatment satisfaction over time using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)
    Timeframe: Baseline and Up to Month12

Arms:
  • 2

Interventions:

  • Drug: CAB LA
  • Drug: RPV LA
  • Drug: RPV
  • Drug: DTG

Keyword:

  • HIV, ART, maintenance, Long acting, LATTE
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 98