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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-25

Study Completion Date

2023-05-14

Brief Summary

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This was 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 participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants who received JULUCA

Virologically suppressed HIV positive participants, on a stable antiretroviral regimen, who switched to the 2-Drug Regimen JULUCA (Dolutegravir \[DTG\] / Rilpivirine \[RPV\]) were included in the study. Participants were followed-up for approximately 3 years during routine clinical practice.

JULUCA

Intervention Type DRUG

JULUCA is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).

Interventions

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JULUCA

JULUCA is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Greated than or equal to (\>=)18 years of age.
* Documented HIV-1 infection.
* Virologically suppressed (HIV-1 ribonucleic acid \[RNA\] less than \[\<\] 50 copies \[c\]/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 greater than (\>) 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No