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

Sponsor
ViiV Healthcare
Study ID
NCT03754803
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HIV symptom distress module (SDM) questionnaire — 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) — 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.

Study Details

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.

Key Dates

Start date
Nov 8, 2018
Status verified
Jul 2025
Primary completion
May 6, 2024
Completion
May 6, 2024

Study Design

Enrollment
376 participants (actual)

Arms

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

Primary Outcome Measure

Percentage of Participants With Sustained Virologic Suppression [ Time Frame: At Year 3 ]

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