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
Results First Received: May 15, 2015  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV Infections

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
387 patients started treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment-naive Patients Patients who were not pretreated with HIV therapy
Patients Switching From Nevirapine IR Patients switching from nevirapine immediate release (IR).
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
Pretreated Patients, Baseline Viral Load >50 Copies/mL Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
Patients With Baseline Viral Load Not Documented Patients with no documented information about the baseline viral load.

Participant Flow:   Overall Study
    Treatment-naive Patients     Patients Switching From Nevirapine IR     Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL     Pretreated Patients, Baseline Viral Load >50 Copies/mL     Patients With Baseline Viral Load Not Documented  
STARTED     49     246     30     22     40  
COMPLETED     43     232     29     21     40  
NOT COMPLETED     6     14     1     1     0  
Lost to Follow-up                 3                 12                 1                 0                 0  
Other reason than stated above                 1                 1                 0                 0                 0  
No reason documented                 2                 1                 0                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from the Treated Set (TS): This patient set includes all HIV-1 infected patients who were dispensed Viramune® and were documented to have taken at least one dose of Viramune®and of a antiretroviral combination partner.

Reporting Groups
  Description
Treatment-naive Patients Patients who were not pretreated with HIV therapy
Patients Switching From Nevirapine IR Patients switching from nevirapine immediate release (IR).
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
Pretreated Patients, Baseline Viral Load>50 Copies/mL Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
Patients With Baseline Viral Load Not Documented Patients with no documented information about the baseline viral load.
Total Total of all reporting groups

Baseline Measures
    Treatment-naive Patients     Patients Switching From Nevirapine IR     Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL     Pretreated Patients, Baseline Viral Load>50 Copies/mL     Patients With Baseline Viral Load Not Documented     Total  
Number of Participants  
[units: participants]
  49     246     30     22     40     387  
Age  
[units: years]
Mean (Standard Deviation)
  34.9  (9.9)     39.8  (13.8)     38.1  (11.1)     33.1  (10.4)     37.4  (13.2)     38.5  (13.1)  
Gender [1]
[units: participants]
           
Female     8     90     11     7     19     135  
Male     41     155     19     14     21     250  
[1] There are two patients with missing gender information, one in the group of the patients switching from nevirapine IR and one in the group of pretreated patients with HIV RNA>=50.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Number of Patients Reporting Rash of Any Severity   [ Time Frame: up to 72 weeks ]

3.  Primary:   Number of Patients Reporting Hepatic Events   [ Time Frame: up to 72 weeks ]

4.  Secondary:   Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)   [ Time Frame: 24 weeks ]

5.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 24   [ Time Frame: baseline and week 24 ]

6.  Secondary:   Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks   [ Time Frame: baseline and week 24 ]

7.  Secondary:   Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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