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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Juluca


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects receiving Juluca<br>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<br>* Juluca is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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2 drug regimen, Juluca, Rilpivirine, Dolutegravir, Antiretroviral, One pill regimen