Active, not recruiting

Study Description:

This is a prospective, non-interventional, multi-center study, in subjects with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study is 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. Approximately, 300 treatment naïve and pre-treated HIV-1 positive subjects will be enrolled in the study. The observation period for the study will be 3 years. Data will be collected from routine clinical care via electronic data capture (EDC) system.

Viiv Study ID:

208983


Clinicaltrials.gov Identifier:

NCT03754803


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

dolutegravir;lamivudine

Collaborators

MUC Research GmbH


Date

November 2018 to December 2021

Type

Observational

Phase

N/A


Gender

Both

Age

18 Years - N/A

Accepts Healthy Volunteers


Study Documents

No documents available
This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Germany, Berlin 10243Recruiting
Germany, Koeln 50668Recruiting
Germany, Weimar 99427Recruiting
Germany, Baden-Wuerttemberg, Mannheim 68161Recruiting
Germany, Bayern, Muenchen 80336Recruiting
Germany, Bayern, Muenchen 80331Recruiting
Germany, Bayern, Muenchen 80335Recruiting
Germany, Berlin, Berlin 12163Recruiting
Germany, Berlin, Berlin 10777Recruiting
Germany, Berlin, Berlin 10629Recruiting
Germany, Berlin, Berlin 14057Recruiting
Germany, Berlin, Berlin 14059Recruiting
Germany, Hamburg, Hamburg 20246Recruiting
Germany, Hamburg, Hamburg 20146Recruiting
Germany, Niedersachsen, Osnabrueck 49090Recruiting
Germany, Nordrhein-Westfalen, Aachen 52062Recruiting
Germany, Nordrhein-Westfalen, Bochum 44787Recruiting
Germany, Nordrhein-Westfalen, Koeln 50674Recruiting

Study Design

  • Primary Purpose: Not Available
  • Allocation: Not Available
  • Study Design: Not Available
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Percentage of subjects with sustained virologic suppression, with Viral load (VL) < 50 Copies per Milliliter (c/mL)
    Timeframe: Up to 36 months

Secondary Outcomes:

  • Percentage of pre-treated subjects with low level viremia
    Timeframe: Up to 36 months

  • Percentage of naïve subjects with low level viremia after initial suppression
    Timeframe: Up to 36 months

  • Percentage of virologic non-responders for naïve subjects
    Timeframe: Up to 36 months

  • Percentage of naïve subjects with virologic rebound
    Timeframe: Up to 36 months

  • Percentage of subjects with VL < 50 c/mL
    Timeframe: Up to 36 months

  • Percentage of subjects with two consecutive VL measurements of >=200 c/mL
    Timeframe: Up to 36 months

  • Percentage of subjects with treatment switch
    Timeframe: Up to 36 months

  • Percentage of subjects with VL > 50 c/mL with emergent resistance mutations
    Timeframe: Up to 36 months

  • Number of monitoring measures
    Timeframe: Up to 36 months

  • Number and frequency of serious adverse events (SAE)
    Timeframe: Up to 36 months

  • Number and frequency of adverse drug reactions (ADRs)
    Timeframe: Up to 36 months

  • Adherence to therapy
    Timeframe: Up to 36 months

  • Change from Baseline for lipid laboratory parameter: lactate dehydrogenase (LDH)
    Timeframe: Baseline and up to 36 months

  • Change from Baseline for lipid laboratory parameters: cholesterol and triglycerides
    Timeframe: Baseline and up to 36 months

  • Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (HIV TSQ)
    Timeframe: Up to 36 months

  • Change in Symptom Distress based on HIV Symptom Distress Module questionnaire
    Timeframe: Up to 36 months

  • Reasons for switching to/prescription of DTG plus 3TC
    Timeframe: Day 1

Arms:
  • N/A

Interventions:

  • Other: HIV Symptom Distress Module Questionnaire
  • Other: HIV treatment satisfaction questionnaire

Keyword:

  • Dolutegravir, Two-drug regimen, Human Immunodeficiency Virus, HIV Symptom Distress Module, Lamivudine, HIV treatment satisfaction questionnaire
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 372