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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03518060
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : April 29, 2020
Sponsor:
Collaborator:
MUC Research GmbH
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
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 or disease Intervention/treatment
HIV Infections Drug: Juluca

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Study Type : Observational
Estimated Enrollment : 200 participants
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
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Number of monitoring measures [ Time Frame: Up to 3 years ]
    Number of therapeutic monitoring measures in HIV-infected subjects will be recorded.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Reason for switch to Juluca [ Time Frame: Baseline ]
    The reasons for switch to Juluca will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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): NCT03518060


Contacts
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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
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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
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Study Director: GSK Clinical Trials ViiV Healthcare
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03518060    
Other Study ID Numbers: 208982
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
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 URL http://clinicalstudydatarequest
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

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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:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Dolutegravir, rilpivirine drug combination
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents