Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
|ClinicalTrials.gov Identifier: NCT01524900|
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : June 2, 2015
Last Update Posted : June 2, 2015
|Condition or disease|
non-interventional uncontrolled observational study
|Study Type :||Observational|
|Actual Enrollment :||398 participants|
|Official Title:||Observational Study Assessing the Safety, Efficacy and Treatment Adherence of Nevirapine Extended Release (Combined With Other Antiretroviral Drugs) in HIV Infected Patients in Daily Clinical Practice|
|Study Start Date :||March 2012|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
|nevirapine extended release|
- Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation [ Time Frame: up to 72 weeks ]The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.
- Number of Patients Reporting Rash of Any Severity [ Time Frame: up to 72 weeks ]Number of patients reporting rash of any severity as adverse event
- Number of Patients Reporting Hepatic Events [ Time Frame: up to 72 weeks ]Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.
- Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) [ Time Frame: 24 weeks ]Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of < 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.
- Change in CD4+ Cell Count From Baseline to Week 24 [ Time Frame: baseline and week 24 ]The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.
- Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks [ Time Frame: baseline and week 24 ]The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
- Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation [ Time Frame: 24 weeks ]The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524900
Show 53 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|