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
- Conditions
- HIV Infections
- Interventions
- Other: HIV Symptom Distress Module QuestionnaireOther: HIV treatment satisfaction questionnaire
- Registration Number
- NCT03754803
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 366
- Subjects with >= 18 years of age.
- Subjects with documented HIV-1 infection.
- Prescription of DTG + 3TC was issued independently from entering this study.
- Subjects with the ability to understand informed consent form and other relevant regulatory documents.
- Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).
- Subjects 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).
- Subjects with hepatitis B virus (HBV)- coinfection.
- Subjects 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.
- Subjects who had previously participated in clinical trials assessing DTG+ 3TC.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment naïve subjects with HIV infection HIV Symptom Distress Module Questionnaire Treatment naïve HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included Pre-treated subjects with HIV infection HIV treatment satisfaction questionnaire Pre-treated HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included. Pre-treated subjects with HIV infection HIV Symptom Distress Module Questionnaire Pre-treated HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included. Treatment naïve subjects with HIV infection HIV treatment satisfaction questionnaire Treatment naïve HIV-1 positive subjects for whom DTG+3TC is indicated according to local label will be included
- Primary Outcome Measures
Name Time Method Percentage of subjects with sustained virologic suppression, with Viral load (VL) < 50 Copies per Milliliter (c/mL) Up to 36 months Percentage of subjects with sustained virologic suppression, defined as VL \<50 c/mL or if between 50-200 c/mL with a subsequent next available measurement \<50 c/mL (within 120 days) will be evaluated.
- Secondary Outcome Measures
Name Time Method Percentage of pre-treated subjects with low level viremia Up to 36 months Percentage of subjects with low level viremia, defined as a VL measurement between \>50 to \<200 c/mL for pre-treated subjects will be evaluated.
Percentage of naïve subjects with low level viremia after initial suppression Up to 36 months Percentage of subjects with low level viremia, defined as a VL measurement between \>50 to \<200 c/mL after initial suppression of \<50 c/mL for naïve subjects will be evaluated.
Percentage of virologic non-responders for naïve subjects Up to 36 months Percentage of virologic non-responders, defined as two consecutive measurements \>=200 c/mL after at least 24 weeks of treatment in naïve subjects will be evaluated.
Percentage of subjects with two consecutive VL measurements of >=200 c/mL Up to 36 months Percentage of subjects with two consecutive VL measurements of \>=200 c/mL will be evaluated.
Percentage of subjects with VL < 50 c/mL Up to 36 months Percentage of subjects with VL \<50 c/mL will be evaluated.
Percentage of subjects with treatment switch Up to 36 months Percentage of subjects with treatment switch due to virologic failure (VF) or due to intolerability determined at the discretion of the physician will be evaluated.
Percentage of subjects with VL > 50 c/mL with emergent resistance mutations Up to 36 months Percentage of subjects with VL \>50 c/mL with emergent resistance mutations will be summarized. Resistance analysis will be performed at the physician's discretion.
Change from Baseline for lipid laboratory parameter: lactate dehydrogenase (LDH) Baseline and up to 36 months Lipid laboratory parameter LDH data will be evaluated at indicated time points.
Change in Symptom Distress based on HIV Symptom Distress Module questionnaire Up to 36 months The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. This included sub-scales change in treatment satisfaction, individual satisfaction with treatment change. Treatment satisfaction score summed all items to produce scores ranging from +30 to -30, higher the score, greater the improvement in satisfaction with treatment, lower score greater is the deterioration in satisfaction. Individual item scores which included All rate score ranging from +3 (much more satisfied, much more convenient, much more flexible) to -3 (much less satisfied, much less convenient, much less flexible). General satisfaction and life style scores all items summed to produce score range +15 to -15, where higher the score greater the improvement in satisfaction, lower score greater is the deterioration in satisfaction.
Reasons for switching to/prescription of DTG plus 3TC Day 1 The reasons for switching to/prescription of DTG plus 3TC as selected by the investigator from a pre-specified list will be summarized
Percentage of naïve subjects with virologic rebound Up to 36 months Percentage of naïve subjects with virologic rebound, defined as two consecutive VL measurements \>=200 c/mL after suppression (one VL \<50 c/mL) will be evaluated.
Number of monitoring measures Up to 36 months Number of monitoring measures (normalized to subject years) will be summarized.
Number and frequency of serious adverse events (SAE) Up to 36 months An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Adherence to therapy Up to 36 months Adherence to therapy will be determined from the number of monthly doses missed.
Number and frequency of adverse drug reactions (ADRs) Up to 36 months An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, that is the relationship cannot be ruled out.
Change in treatment satisfaction based on HIV Treatment Satisfaction questionnaire (HIV TSQ) Up to 36 months 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. In treatment satisfaction score will range from 0-60, higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction , there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale.
Change from Baseline for lipid laboratory parameters: cholesterol and triglycerides Baseline and up to 36 months Lipid laboratory parameters cholesterol and triglycerides data will be evaluated at indicated time points.
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Weimar, Germany