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Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany

NCT ID: NCT03754803

Last Updated: 2025-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-08

Study Completion Date

2024-05-06

Brief Summary

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This is a prospective, non-interventional, multi-center study, in participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study was to generate the real world evidence for the use of DTG+3TC in routine clinical care in Germany to supplement data obtained from controlled clinical trials. Treatment naïve and pre-treated HIV-1 positive participants were enrolled in the study. The observation period for the study was 3 years. Data was collected from routine clinical care via electronic data capture (EDC) system.

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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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Total participants

Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.

HIV symptom distress module (SDM) questionnaire

Intervention Type OTHER

The SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.

HIV treatment satisfaction questionnaire (TSQ)

Intervention Type OTHER

The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.

Interventions

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HIV symptom distress module (SDM) questionnaire

The SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.

Intervention Type OTHER

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 and flexibility.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants \>= 18 years of age.
* Participants with documented HIV-1 infection.
* Prescription of DTG + 3TC was issued independently from entering this study.
* Participants with the ability to understand informed consent form and other relevant regulatory documents.

Exclusion Criteria

* Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).
* Participants with VL \> 500 c/mL.
* Any antiretroviral therapy for the treatment of HIV-1 in addition to DTG and 3TC or the DTG/3TC fixed dose combination (FDC).
* Participants with hepatitis B virus (HBV)- coinfection.
* Participants with current participation in the ongoing non-interventional study TRIUMPH (study number: 202033, NCT number: NCT02342769) or in any interventional clinical trial irrespective of indication.
* Participants who had previously participated in clinical trials assessing DTG+ 3TC.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MUC Research GmbH

OTHER

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Aachen, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Bochum, , Germany

Site Status

GSK Investigational Site

Cologne, , Germany

Site Status

GSK Investigational Site

Cologne, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Mannheim, , Germany

Site Status

GSK Investigational Site

München, , Germany

Site Status

GSK Investigational Site

München, , Germany

Site Status

GSK Investigational Site

München, , Germany

Site Status

GSK Investigational Site

Osnabrück, , Germany

Site Status

GSK Investigational Site

Weimar, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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208983

Identifier Type: -

Identifier Source: org_study_id

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