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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Juluca

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14059
    • GSK Investigational Site
  • Berlin, Germany, 14057
    • GSK Investigational Site
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 10629
    • GSK Investigational Site
  • Berlin, Germany, 12163
    • GSK Investigational Site
  • Berlin, Germany, 10243
    • GSK Investigational Site
  • Chemnitz, Germany, 09111
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20146
    • GSK Investigational Site
  • Koeln, Germany, 50668
    • GSK Investigational Site
  • Weimar, Germany, 99427
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Tuebingen, Baden-Wuerttemberg, Germany, 72076
      • GSK Investigational Site
  • Bayern
    • Muenchen, Bayern, Germany, 81675
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80335
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80336
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80331
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80801
      • GSK Investigational Site
  • Niedersachsen
    • Osnabrueck, Niedersachsen, Germany, 49090
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52062
      • GSK Investigational Site
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • GSK Investigational Site
    • Essen, Nordrhein-Westfalen, Germany, 45122
      • GSK Investigational Site
    • Koeln, Nordrhein-Westfalen, Germany, 50674
      • GSK Investigational Site
    • Muenster, Nordrhein-Westfalen, Germany, 48143
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with sustained virologic suppression	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.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with low level viremia	Low level viremia is defined as a VL measurement >50 to <200 c/mL. Number of subjects with low level viremia will be presented.	Up to 3 years
Number of subjects with VL >50 c/mL with emergent resistance mutations	Number of subjects with VL >50 c/mL with emergent resistance mutations will be presented.	Up to 3 years
Number of subjects with virologic rebound	Virologic rebound is defined as two consecutive VL measurements of >=200 c/mL. Number of subjects with virologic rebound will be presented.	Up to 3 years
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	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.	Up to 3 years
Number of subjects with VL <50 c/mL	Number of subjects with VL <50 c/mL will be presented.	Up to 3 years
Number of monitoring measures	Number of therapeutic monitoring measures in HIV-infected subjects will be recorded.	Up to 3 years
Number and frequency of serious adverse events (SAEs)	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.	Up to 3 years
Number and frequency of adverse drug reactions (ADRs)	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.	Up to 3 years
Adherence to therapy	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.	Up to 3 years
Change in lipid laboratory values	Impact on lipid metabolism will be assessed by changes in lipid laboratory values. Changes in lipid laboratory values will be recorded.	Up to 3 years
Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (TSQ)	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.	Up to 3 years
Change in symptom distress based on HIV Symptom Distress Module questionnaire	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.	Up to 3 years
Reason for switch to Juluca	The reasons for switch to Juluca will be recorded.	Baseline

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: MUC Research GmbH
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): May 14, 2023
• Study Completion (Actual): May 14, 2023

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dolutegravir; Rilpivirine; Antiretroviral; 2 drug regimen; Juluca; One pill regimen
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Dolutegravir, rilpivirine drug combination
• Other Study ID Numbers: 208982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site URL http://clinicalstudydatarequest
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No