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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

Detailed Description

Study Design:

non-interventional uncontrolled observational study

• Study Type: Observational
• Enrollment (Actual): 398

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Boehringer Ingelheim Investigational Site 6
  • Salzburg, Austria
    • Boehringer Ingelheim Investigational Site 5
  • Vienna, Austria
    • Boehringer Ingelheim Investigational Site 1
  • Vienna, Austria
    • Boehringer Ingelheim Investigational Site 2
  • Vienna, Austria
    • Boehringer Ingelheim Investigational Site 3
  • Wels, Austria
    • Boehringer Ingelheim Investigational Site 4
• Poland
  • Bialystok, Poland
    • Boehringer Ingelheim Investigational Site 8
  • Bialystok, Poland
    • Boehringer Ingelheim Investigational Site 7
  • Bydgoszcz, Poland
    • Boehringer Ingelheim Investigational Site 9
  • Bydgoszcz, Poland
    • Boehringer Ingelheim Investigational Site 10
  • Chorzów, Poland
    • Boehringer Ingelheim Investigational Site 11
  • Chorzów, Poland
    • Boehringer Ingelheim Investigational Site 12
  • Gdañsk, Poland
    • Boehringer Ingelheim Investigational Site 13
  • Gdañsk, Poland
    • Boehringer Ingelheim Investigational Site 14
  • Gdañsk, Poland
    • Boehringer Ingelheim Investigational Site 15
  • Kraków, Poland
    • Boehringer Ingelheim Investigational Site 16
  • Kraków, Poland
    • Boehringer Ingelheim Investigational Site 17
  • Poznañ, Poland
    • Boehringer Ingelheim Investigational Site 18
  • Wroc£aw, Poland
    • Boehringer Ingelheim Investigational Site 19
  • Wroc£aw, Poland
    • Boehringer Ingelheim Investigational Site 20
• Romania
  • Bacau, Romania
    • Boehringer Ingelheim Investigational Site 50
  • Brasov, Romania
    • Boehringer Ingelheim Investigational Site 51
  • Brasov, Romania
    • Boehringer Ingelheim Investigational Site 52
  • Brasov, Romania
    • Boehringer Ingelheim Investigational Site 53
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 21
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 22
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 23
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 24
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 25
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 26
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 27
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 28
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 29
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 30
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 31
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 32
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 33
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 34
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 35
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 36
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 37
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 38
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 39
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 40
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 41
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 42
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 43
  • Bucuresti, Romania
    • Boehringer Ingelheim Investigational Site 44
  • Constanta, Romania
    • Boehringer Ingelheim Investigational Site 46
  • Constanta, Romania
    • Boehringer Ingelheim Investigational Site 47
  • Constanta, Romania
    • Boehringer Ingelheim Investigational Site 48
  • Giurgiu, Romania
    • Boehringer Ingelheim Investigational Site 45
  • Ploiesti, Romania
    • Boehringer Ingelheim Investigational Site 49

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HIV-1 infected patients

Description

Inclusion criteria:

1. HIV-1 infected male and female 18 years and above;
2. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
nevirapine extended release

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 1100.1550