Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice

Study Overview
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Brief Summary
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This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and pre-treated patients switching from nevirapine immediate release or other anti-retroviral therapy (ART) will be included in the study. The decision to initiate treatment with nevirapine extended release is independent of this study and is based entirely on individual patient need and the judgement of the treating physician. The aim of the study is to assess the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1 infected patients in routine clinical practice. It is planned to document five visits for each patient over a twenty four week observational period.

Detailed Description
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Study Design: non-interventional uncontrolled observational study

Official Title
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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

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: HIV-1 infected male and female 18 years and above; anti-retroviral therapy (ART) naive and pre-treated patients switching from a nevirapine immediate release or other ART. Exclusion criteria: Consistent with the current VIRAMUNE prolonged release SPC.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nevirapine extended release<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | 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. | up to 72 weeks | 
| Number of Patients Reporting Rash of Any Severity | Number of patients reporting rash of any severity as adverse event | up to 72 weeks | 
| Number of Patients Reporting Hepatic Events | 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. | up to 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | 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. | 24 weeks | 
| Change in CD4+ Cell Count From Baseline to 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. | baseline and week 24 | 
| Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | 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. | baseline and week 24 | 
| Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation. | 24 weeks |