HIV Infections
Conditions
Brief summary
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients
Interventions
DRUGNon-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score | Baseline, month 1, 6 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 in viral load | Baseline and month 3, 6, 9, 12 |
| Changes from baseline in creatinine | Baseline, month 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 |
| 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 symptom scale score | Baseline, month 1, 6 and 12 |
| Changes from baseline in plasma urea | Baseline, month 12 |
Outcome results
None listed