Text Size

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

This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01524900
First received: January 17, 2012
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients reporting adverse events [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]
  • Proportion of patients reporting serious adverse events [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]
  • Proportion of patients with adverse events leading to discontinuation [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients reporting rash of any severity [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]
  • Proportion of patients reporting hepatic events of any severity [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients with virologic response at week 24 (viral load <50 copies/mL) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in CD4+ cell count from baseline to week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in Morisky Medication Adherence Scale score from baseline to 24 weeks [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients reporting once daily nevirapine more convenient than twice daily formulation [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of respondents reporting once daily nevirapine as "very much more convenient" compared to twice daily formulation [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 470
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524900

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 64 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01524900     History of Changes
Other Study ID Numbers: 1100.1550
Study First Received: January 17, 2012
Last Updated: May 2, 2013
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
Anti-HIV Agents
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Nevirapine
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013