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

HIV Infections Clinical Trial

— JUNGLE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518060
• Other study ID #: 208982
• Status: Completed
• Start date: June 27, 2018
• Est. completion date: May 14, 2023

Study information

• Verified date: August 2023
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 14, 2023
• Est. primary completion date: May 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Chemnitz
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Osnabrueck	Niedersachsen
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weimar

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	MUC Research GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of subjects with VL <50 c/mL	Number of subjects with VL <50 c/mL will be presented.	Up to 3 years
Secondary	Number of monitoring measures	Number of therapeutic monitoring measures in HIV-infected subjects will be recorded.	Up to 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Reason for switch to Juluca	The reasons for switch to Juluca will be recorded.	Baseline