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NCT02191202 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Observational Study of the Impact on Quality-of-life of a Switch From a Virologically Effective Regimen to a Regimen Containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) Clinical Phase IV

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02191202
Other study ID # 1100.1461
Secondary ID
Status Completed
Phase N/A
First received July 15, 2014
Last updated July 15, 2014
Start date June 2004

Study information
Verified date July 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 283
Est. completion date
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score Baseline, month 1, 6 and 12 No
Secondary 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 No
Secondary Changes in symptom scale score Baseline, month 1, 6 and 12 No
Secondary Changes in Hospital Anxiety and Depression scale (HADS) Baseline, month 1, 6 and 12 No
Secondary Changes in cluster of differentiation 4 (CD4) cell count Baseline and month 3, 6, 9, 12 No
Secondary Changes in viral load Baseline and month 3, 6, 9, 12 No
Secondary Changes in liver function tests Baseline and month 3, 6, 9, 12 No
Secondary Changes in total cholesterol Baseline, month 6 and 12 No
Secondary Changes in triglycerides Baseline, month 6 and 12 No
Secondary Changes in fasting blood glucose Baseline, month 6 and 12 No
Secondary Changes in haemoglobin Baseline, month 6 and 12 No
Secondary Changes from baseline in plasma urea Baseline, month 12 No
Secondary Changes from baseline in creatinine Baseline, month 12 No
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