Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression

N/ACompletedNCT02191202

Boehringer Ingelheim283 enrolled

Overview

Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients

Study Type

OBSERVATIONAL

Enrollment

283

Conditions

HIV Infections

Interventions

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)DRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score

Time frame: Baseline, month 1, 6 and 12

Secondary Outcomes

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

Time frame: Baseline, 12 months

Changes in symptom scale score

Time frame: Baseline, month 1, 6 and 12

Changes in Hospital Anxiety and Depression scale (HADS)

Time frame: Baseline, month 1, 6 and 12

Changes in cluster of differentiation 4 (CD4) cell count

Time frame: Baseline and month 3, 6, 9, 12

Changes in viral load

Time frame: Baseline and month 3, 6, 9, 12

Changes in liver function tests

Time frame: Baseline and month 3, 6, 9, 12

Changes in total cholesterol

Time frame: Baseline, month 6 and 12

Changes in triglycerides

Time frame: Baseline, month 6 and 12

Changes in fasting blood glucose

Time frame: Baseline, month 6 and 12

Changes in haemoglobin

Time frame: Baseline, month 6 and 12

Data from ClinicalTrials.gov

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