N/A
Completed N=368
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
Source: ClinicalTrials.gov NCT03754803 ↗Enrolled (actual)
368
Serious AEs
21.5%
Results posted
Aug 2025
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Suppression — 67.7; 75.5; 0; 0.3 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Suppression |
67.7; 75.5; 0; 0.3 | — |
| SECONDARY Percentage of Participants With Low Level Viremia |
3.2; 1.8; 3.2; 1.5; 6.5; 0.9 | — |
| SECONDARY Percentage of Participants With Virologic Rebound |
3.4; 0.3 | — |
| SECONDARY Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability |
3.2; 1.5; 9.7; 3.6 | — |
| SECONDARY Percentage of Participants With Missed Monthly Doses |
93; 14; 1; 1; 98; 1 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
1; 78 | — |
| SECONDARY Frequency of Serious Adverse Events |
0.01; 0.09 | — |
| SECONDARY Number of Serious and Non-serious Adverse Drug Reactions (ADRs) |
5; 27; 5; 22 | — |
| SECONDARY Frequency of Any Adverse Drug Reactions |
0.06; 0.03 | — |
| SECONDARY Discontinuation Rates Due to Adverse Drug Reactions |
3.9 | — |
| SECONDARY Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations |
0; 0.3 | — |
| SECONDARY Change in Lipid Laboratory Values |
13.0; -4.0; -1.0; -1.0; 8.5; -6.0 | — |
| SECONDARY Percentage of Participants With Reasons for Therapy Switch to DTG+3TC |
39; 14; 62; 26; 1; 21 | — |
| SECONDARY Percentage of Participants With Reasons for DTG+3TC Therapy Initiation |
3; 45; 6; 6; 16; 23 | — |
| SECONDARY Change in Treatment Satisfaction |
1.0; 1.0; 1.0 | — |
| SECONDARY Change in Symptom Distress |
-2.0; -2.0; 3.0; 0.0; -1.0; 0.0 | — |
| SECONDARY Number of HIV-RNA Monitoring Measures |
4; 4 | — |
| SECONDARY Percentage of Participants Referred to Another Medical Specialist |
38.7; 71.6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03754803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.