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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 1, 2021

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ViiV Healthcare
  • Collaborator
    • MUC Research GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, ViiV Healthcare
  • Overall Contact(s)
    • US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

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