NCT03754803

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 376 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2018-11-08
• Primary completion: 2024-05-06
• Completion: 2024-05-06
• First posted: 2018-11-27
• Last updated: 2025-08-17
• Results posted: 2025-08-17

Locations

18 sites across 1 country: Germany