Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression
Completed
- Conditions
- HIV Infections
- Interventions
- Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
- Registration Number
- NCT02191202
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Inclusion Criteria
- NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load < 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included
- Patients must read and write French
Exclusion Criteria
- Patients in whom a new treatment is initiated because of treatment failure
- new treatment does not comprise an NNRTI
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) -
- Primary Outcome Measures
Name Time Method Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score Baseline, month 1, 6 and 12
- Secondary Outcome Measures
Name Time Method Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population Baseline, 12 months Changes in liver function tests Baseline and month 3, 6, 9, 12 Changes in total cholesterol Baseline, month 6 and 12 Changes in triglycerides Baseline, month 6 and 12 Changes in fasting blood glucose Baseline, month 6 and 12 Changes in haemoglobin Baseline, month 6 and 12 Changes from baseline in plasma urea Baseline, month 12 Changes from baseline in creatinine Baseline, month 12 Changes in symptom scale score Baseline, month 1, 6 and 12 Changes in Hospital Anxiety and Depression scale (HADS) Baseline, month 1, 6 and 12 Changes in cluster of differentiation 4 (CD4) cell count Baseline and month 3, 6, 9, 12 Changes in viral load Baseline and month 3, 6, 9, 12