PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736502
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : August 31, 2012
Last Update Posted : March 7, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: HIV Infections

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 280 patients enrolled but two patients were lost to follow up before the second visit (2 weeks). For these two patients no information about Nevirapine intake could be assessed. So they were not included in the treated set which was used for most of the analyses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an observational, non-interventional, uncontrolled, prospective post marketing study.

Reporting Groups
Nevirapine Patients treated with 200 mg Nevirapine twice daily (administered orally).

Participant Flow:   Overall Study
STARTED   278 [1] 
Adverse Event                22 
Lack of Efficacy                16 
Lost to Follow-up                27 
[1] Entered and treated.

  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.
Treated set

Reporting Groups
Nevirapine Patients treated with 200 mg Nevirapine twice daily (administered orally).

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 38.5  (10.3) 
[Units: Participants]
Female   59 
Male   219 

  Outcome Measures

1.  Primary:   Proportion of Patients Reporting Adverse Events   [ Time Frame: 48 weeks ]

2.  Secondary:   Virologic Response (VR)   [ Time Frame: 48 weeks ]

3.  Secondary:   Change in CD4+ Cell Count From Baseline to Week 48   [ Time Frame: Baseline and week 48 ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information