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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01524900
First received: January 17, 2012
Last updated: June 1, 2015
Last verified: June 2015
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of patients reporting rash of any severity as adverse event

  • Number of Patients Reporting Hepatic Events [ Time Frame: up to 72 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.


Enrollment: 398
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
nevirapine extended release

Detailed Description:

Study Design:

non-interventional uncontrolled observational study

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV-1 infected patients

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524900

  Show 53 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01524900     History of Changes
Other Study ID Numbers: 1100.1550
Study First Received: January 17, 2012
Results First Received: May 15, 2015
Last Updated: June 1, 2015
Health Authority: Austria: Medicines and Medical Devices Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
Romania: National Medicines Agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on June 30, 2015