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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.

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ClinicalTrials.gov Identifier: NCT00736502
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : August 31, 2012
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition HIV Infections
Enrollment 280
Recruitment Details 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 This was an observational, non-interventional, uncontrolled, prospective post marketing study.
Arm/Group Title Nevirapine
Hide Arm/Group Description Patients treated with 200 mg Nevirapine twice daily (administered orally).
Period Title: Overall Study
Started 278 [1]
Completed 213
Not Completed 65
Reason Not Completed
Adverse Event             22
Lack of Efficacy             16
Lost to Follow-up             27
[1]
Entered and treated.
Arm/Group Title Nevirapine
Hide Arm/Group Description Patients treated with 200 mg Nevirapine twice daily (administered orally).
Overall Number of Baseline Participants 278
Hide Baseline Analysis Population Description
Treated set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 278 participants
38.5  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 278 participants
Female
59
  21.2%
Male
219
  78.8%
1.Primary Outcome
Title Proportion of Patients Reporting Adverse Events
Hide Description the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.
Arm/Group Title Nevirapine
Hide Arm/Group Description:
Patients treated with 200 mg Nevirapine twice daily (administered orally).
Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: Percentage of participants
any event 25.5
serious adverse events 4.3
adverse events leading to discontinuation 9.7
rash, any severity 3.2
hepatic events, any severity 3.2
Central Nervous system side effects, any severity 3.6
2.Secondary Outcome
Title Virologic Response (VR)
Hide Description VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by 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 was defined as a permanent discontinuation of Nevirapine.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Nevirapine
Hide Arm/Group Description:
Patients treated with 200 mg Nevirapine twice daily (administered orally).
Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: Participants
with VR 139
without VR 16
missing 123
3.Secondary Outcome
Title Change in CD4+ Cell Count From Baseline to Week 48
Hide Description Calculated as CD4+ cell count at week 48 minus the baseline value
Time Frame Baseline and week 48
Hide Outcome Measure Data
Hide Analysis Population Description
TS with non-missing data at baseline and week 48
Arm/Group Title Nevirapine
Hide Arm/Group Description:
Patients treated with 200 mg Nevirapine twice daily (administered orally).
Overall Number of Participants Analyzed 155
Mean (Standard Deviation)
Unit of Measure: Cells/mm^3
148.5  (154.6)
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nevirapine
Hide Arm/Group Description Patients treated with 200 mg Nevirapine twice daily (administered orally).
All-Cause Mortality
Nevirapine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nevirapine
Affected / at Risk (%)
Total   12/278 (4.32%) 
Blood and lymphatic system disorders   
Anemia  1  1/278 (0.36%) 
Lymphadenopathy, generalised  1  1/278 (0.36%) 
Pancytopenia  1  1/278 (0.36%) 
Gastrointestinal disorders   
Abdominal pain  1  1/278 (0.36%) 
Cholecystitis  1  1/278 (0.36%) 
Diarrhea  1  1/278 (0.36%) 
Gastroenteritis  1  1/278 (0.36%) 
Melena  1  1/278 (0.36%) 
General disorders   
Fever  1  2/278 (0.72%) 
Malaise  1  1/278 (0.36%) 
Pregnancy  1  1/278 (0.36%) 
Infections and infestations   
Clostridia enteritis  1  1/278 (0.36%) 
Helicobacter phylori infection  1  1/278 (0.36%) 
porta catheter infection  1  1/278 (0.36%) 
Staphylococcus sepsis  1  1/278 (0.36%) 
Injury, poisoning and procedural complications   
Fracture of foot  1  1/278 (0.36%) 
Investigations   
Hyperkaliemia  1  1/278 (0.36%) 
Musculoskeletal and connective tissue disorders   
Chest pain  1  1/278 (0.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lymphoma of the brain  1  1/278 (0.36%) 
Nervous system disorders   
Diabetes insipitus  1  1/278 (0.36%) 
Respiratory, thoracic and mediastinal disorders   
Pneumocystitis  1  1/278 (0.36%) 
Pneumonia  1  2/278 (0.72%) 
Skin and subcutaneous tissue disorders   
Enanthema  1  1/278 (0.36%) 
Herpes eczema  1  1/278 (0.36%) 
Rash  1  1/278 (0.36%) 
Vascular disorders   
Fever  1  1/278 (0.36%) 
Hypertension  1  1/278 (0.36%) 
Pulmonary embolism  1  2/278 (0.72%) 
Shunt thrombosis  1  1/278 (0.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nevirapine
Affected / at Risk (%)
Total   0/278 (0.00%) 
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00736502     History of Changes
Other Study ID Numbers: 1100.1527
First Submitted: July 7, 2008
First Posted: August 18, 2008
Results First Submitted: July 30, 2012
Results First Posted: August 31, 2012
Last Update Posted: March 7, 2014