Clinical Trials

MainTitle

Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1 (JUNGLE)

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2020 by ViiV Healthcare

Sponsor
ViiV Healthcare

Collaborator
MUC Research GmbH

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT03518060

First received: April 26, 2018
Last updated: April 27, 2020
Last Verified: April 2020
History of Changes
Purpose

Purpose

This is a prospective, non‐interventional, single‐arm, multi‐center study aimed at gathering real‐world data on Juluca use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive subjects in Germany. Approximately 250 virologically suppressed HIV positive subjects on stable antiretroviral therapy (ART) will be included in the study at the discretion of treating physician. Eligible subjects will be followed up for approximately 3 years and data will be collected during routine clinical care.

Condition Intervention
HIV Infections

Drug : Juluca

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Durability of Antiretroviral Suppression and the Real World Clinical Profile of the Novel 2‐Drug Regimen Juluca, a Onepill‐Regimen Consisting of Dolutegravir and Rilpivirine, in Routine Clinical Care in Germany

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Number of subjects with sustained virologic suppression [ Time Frame: Up to 3 years ]
    Sustained virological suppression is defined as viral load (VL) <50 copies/milliliter (c/mL) or if between 50 to 200 c/mL with a subsequent next available measurement (within 120 days) <50 c/mL at year 1, 2 and 3.
Secondary Outcome Measures:
  • Number of subjects with low level viremia [ Time Frame: Up to 3 years ]
    Low level viremia is defined as a VL measurement >50 to <200 c/mL. Number of subjects with low level viremia will be presented.
  • Number of subjects with VL >50 c/mL with emergent resistance mutations [ Time Frame: Up to 3 years ]
    Number of subjects with VL >50 c/mL with emergent resistance mutations will be presented.
  • Number of subjects with virologic rebound [ Time Frame: Up to 3 years ]
    Virologic rebound is defined as two consecutive VL measurements of >=200 c/mL. Number of subjects with virologic rebound will be presented.
  • Number of subjects with two consecutive measurements of >=200 c/mL, or treatment switch due to virological failure (VF) or due to intolerability as determined at the discretion of the physician [ Time Frame: Up to 3 years ]
    Number of subjects with two consecutive measurements of >=200 c/mL, or treatment switch due to VF or due to intolerability as determined at the discretion of the physician will be presented.
  • Number of subjects with VL <50 c/mL [ Time Frame: Up to 3 years ]
    Number of subjects with VL <50 c/mL will be presented.
  • Number of monitoring measures [ Time Frame: Up to 3 years ]
    Number of therapeutic monitoring measures in HIV-infected subjects will be recorded.
  • Number and frequency of serious adverse events (SAEs) [ Time Frame: Up to 3 years ]
    An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
  • Number and frequency of adverse drug reactions (ADRs) [ Time Frame: Up to 3 years ]
    An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out.
  • Adherence to therapy [ Time Frame: Up to 3 years ]
    Adherence refers to missed monthly doses. At Baseline and at each Follow‐up visit, subjects will be asked to give an estimation of their level of adherence to their ART.
  • Change in lipid laboratory values [ Time Frame: Up to 3 years ]
    Impact on lipid metabolism will be assessed by changes in lipid laboratory values. Changes in lipid laboratory values will be recorded.
  • Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (TSQ) [ Time Frame: Up to 3 years ]
    The HIV TSQ is a 10‐item‐self‐reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility, etc.
  • Change in symptom distress based on HIV Symptom Distress Module questionnaire [ Time Frame: Up to 3 years ]
    HIV Symptom Distress Module (also called the HIV Symptom Index or Symptoms Impact Questionnaire) is a 20‐item self‐reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.
  • Reason for switch to Juluca [ Time Frame: Baseline ]
    The reasons for switch to Juluca will be recorded.

Estimated Enrollment: 200
Study Start Date: June 27, 2018
Estimated Study Completion Date: July 31, 2022
Estimated Primary Completion Date: December 1, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Subjects receiving Juluca
Approximately 250 virologically suppressed HIV positive subjects on a stable antiretroviral regimen as indicated in local SmPC of Juluca will be included in the study. The subjects will be followed for approximately 3 years during routine clinical practice.
Drug: Juluca

Juluca is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Approximately, 250 treatment experienced and virologically suppressed HIV positive subjects will be included in this study. The subjects will be included at the discretion of the treating physician based on the local summary of product characteristics (SmPC) of Juluca.

Criteria

Inclusion Criteria:

  • >=18 years of age.
  • Documented HIV‐1 infection.
  • Virologically suppressed (HIV‐1 ribonucleic acid [RNA] <50 c/mL for at least 6 months)
  • Prescription for Juluca was issued independently from entering this study.
  • Ability to understand informed consent form and other relevant study documents


Exclusion Criteria:
  • Any contraindication according to Juluca SmPC.
  • Documented viral load >50 c/mL at any time point within 6 months prior to inclusion into this study.
  • History of treatment failure.
  • Known or suspected substitutions associated with resistance to any Non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
  • Any ART for the treatment of HIV‐1 in addition to Juluca.
  • Hepatitis B virus (HBV)‐co-infection.
  • Current participation in the ongoing non‐interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
  • Previous participation in clinical trials involving Juluca.

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03518060

Contacts

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

Locations

Germany
GSK Investigational Site Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Christoph Berg
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80331
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Ramona Pauli
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80335
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Hans Jaeger
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80336
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Nils Postel
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80801
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Anja Meurer
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 81675
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Christoph Spinner
GSK Investigational Site Recruiting
Osnabrueck, Niedersachsen, Germany, 49090
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Nils Schuebel
GSK Investigational Site Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52062
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Heribert Knechten
GSK Investigational Site Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44787
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Norbert Brockmeyer
GSK Investigational Site Recruiting
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Stefan Esser
GSK Investigational Site Recruiting
Koeln, Nordrhein-Westfalen, Germany, 50674
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Stefan Scholten
GSK Investigational Site Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48143
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Stefan Christensen
GSK Investigational Site Recruiting
Berlin, Germany, 10117
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Sven Schellberg
GSK Investigational Site Recruiting
Berlin, Germany, 10243
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Christiane Cordes
GSK Investigational Site Recruiting
Berlin, Germany, 10243
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Heribert Hillenbrand
GSK Investigational Site Recruiting
Berlin, Germany, 10629
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Thomas Wuensche
GSK Investigational Site Recruiting
Berlin, Germany, 12163
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Gordon Weinberg
GSK Investigational Site Recruiting
Berlin, Germany, 14057
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Ulrich Bohr
GSK Investigational Site Recruiting
Berlin, Germany, 14059
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Kevin Ummard-Berger
GSK Investigational Site Recruiting
Chemnitz, Germany, 09111
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Thomas Heuchel
GSK Investigational Site Recruiting
Hamburg, Germany, 20146
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Hans-Juergen Stellbrink
GSK Investigational Site Recruiting
Hamburg, Germany, 20246
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Olaf Degen
GSK Investigational Site Recruiting
Koeln, Germany, 50668
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Christoph Wyen
GSK Investigational Site Recruiting
Weimar, Germany, 99427
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com
Principal Investigator: Thomas Seidel

Sponsors and Collaborators

ViiV Healthcare
MUC Research GmbH

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT03518060   History of Changes  
Other Study ID Numbers: 208982  
Study First Received: April 26, 2018  
Last Updated: April 27, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by ViiV Healthcare:

2 drug regimen
Juluca
Rilpivirine
Dolutegravir
Antiretroviral
One pill regimen

Additional relevant MeSH terms:
HIV Infections
Dolutegravir, rilpivirine drug combination

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.