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

NCT03754803 | Completed Results

• 1 other identifier: 208983
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 18

Brief 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

Keywords

Dolutegravir; Two-drug regimen; Human Immunodeficiency Virus; HIV Symptom Distress Module; Lamivudine; HIV treatment satisfaction questionnaire

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Suppression

  Virologic suppression is defined as a viral load (VL) less than (\<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement \<50 c/mL (within 120 days).

  At Year 3

Secondary Outcomes (17)

• Percentage of Participants With Low Level Viremia

  At Month 6 and years 1, 2 and 3

• Percentage of Participants With Virologic Rebound

  From Baseline until Year 3

• Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability

  From Baseline until Year 3

• Percentage of Participants With Missed Monthly Doses

  At years 1, 2 and 3

• Number of Serious Adverse Events (SAEs)

  From Baseline until Year 3

Study Arms (1)

Total participants

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

Other: HIV symptom distress module (SDM) questionnaire; Other: HIV treatment satisfaction questionnaire (TSQ)

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.

Total participants

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.

Total participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treatment naïve and pre-treated HIV-1 positive participants from Germany were included in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• MUC Research GmbH: collaborator

Study Sites (18)

GSK Investigational Site

Aachen, 52062, Germany

Location

GSK Investigational Site

Berlin, 10243, Germany

Location

GSK Investigational Site

Berlin, 10629, Germany

Location

GSK Investigational Site

Berlin, 10777, Germany

Location

GSK Investigational Site

Berlin, 12163, Germany

Location

GSK Investigational Site

Berlin, 14057, Germany

Location

GSK Investigational Site

Berlin, 14059, Germany

Location

GSK Investigational Site

Bochum, 44787, Germany

Location

GSK Investigational Site

Cologne, 50668, Germany

Location

GSK Investigational Site

Cologne, 50674, Germany

Location

GSK Investigational Site

Hamburg, 20146, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

Mannheim, 68161, Germany

Location

GSK Investigational Site

München, 80331, Germany

Location

GSK Investigational Site

München, 80335, Germany

Location

GSK Investigational Site

München, 80336, Germany

Location

GSK Investigational Site

Osnabrück, 49090, Germany

Location

GSK Investigational Site

Weimar, 99427, Germany

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

SDM; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: November 27, 2018
• Study Start: November 8, 2018
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (18)