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Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00819052
First Posted: January 8, 2009
Last Update Posted: November 10, 2014
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: December 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Nevirapine XR
Drug: Nevirapine IR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two patients were randomized, but have not been treated. They were excluded from the treated set.

Reporting Groups
  Description
Nevirapine Immediate Release (NVP IR) Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine Extended Release (NVP XR) Nevirapine extended release 400 mg tablets given once daily

Participant Flow:   Overall Study
    Nevirapine Immediate Release (NVP IR)   Nevirapine Extended Release (NVP XR)
STARTED   148   295 
COMPLETED   142   281 
NOT COMPLETED   6   14 
Adverse Event                0                5 
Protocol Violation                1                2 
Lost to Follow-up                1                2 
Withdrawal by Subject                1                2 
Lack of Efficacy                1                1 
Pregnancy                1                2 
Death or events leading to death                1                0 



  Baseline Characteristics
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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.
Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment

Reporting Groups
  Description
Nevirapine Immediate Release (NVP IR) Nevirapine immediate release 200 mg tablets given twice daily
Nevirapine Extended Release (NVP XR) Nevirapine extended release 400 mg tablets given once daily
Total Total of all reporting groups

Baseline Measures
   Nevirapine Immediate Release (NVP IR)   Nevirapine Extended Release (NVP XR)   Total 
Overall Participants Analyzed 
[Units: Participants]
 148   295   443 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.6  (9.8)   47.3  (9.6)   47.4  (9.7) 
Age, Customized 
[Units: Participants]
     
18 to < 41 years   36   70   106 
41 to < 56 years   79   168   247 
56 to < 65 years   24   38   62 
65 years or more   9   19   28 
Gender 
[Units: Participants]
     
Female   20   49   69 
Male   128   246   374 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   0   5   5 
Black   14   20   34 
White   134   270   404 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic / Latino   132   269   401 
Not Hispanic / Latino   16   26   42 
Region of Enrollment 
[Units: Participants]
     
North America   46   98   144 
Europe   102   197   299 
Smoking History 
[Units: Participants]
     
Never smoked   68   131   199 
Ex-smoker   37   67   104 
Current smoker   43   97   140 
Alcohol Status 
[Units: Participants]
     
Non drinker   44   75   119 
Drinks - no interfere with trial   103   214   317 
Drinks - could interfere with trial   1   6   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 24 ]

2.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population   [ Time Frame: week 2 ]

3.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population   [ Time Frame: week 4 ]

4.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population   [ Time Frame: week 8 ]

5.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population   [ Time Frame: week 12 ]

6.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population   [ Time Frame: week 24 ]

7.  Secondary:   Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 0 to 24 ]

8.  Secondary:   Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population   [ Time Frame: week 0 ]

9.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 2 ]

10.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 4 ]

11.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 8 ]

12.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 12 ]

13.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 24 ]

14.  Secondary:   Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 24 ]

15.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 48 ]

16.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 60 ]

17.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 72 ]

18.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 84 ]

19.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 96 ]

20.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 108 ]

21.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 120 ]

22.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 132 ]

23.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 144 ]

24.  Secondary:   Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: last available visit, up to 144 weeks ]

25.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 48 ]

26.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 60 ]

27.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 72 ]

28.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 84 ]

29.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 96 ]

30.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 108 ]

31.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 120 ]

32.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 132 ]

33.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, week 144 ]

34.  Secondary:   Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population   [ Time Frame: baseline, last available visit (up to 144 weeks) ]

35.  Secondary:   Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144   [ Time Frame: week 144 ]

36.  Secondary:   Change From Baseline in VL (HIV-1 Viral Load) at Each Visit   [ Time Frame: week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit ]

37.  Secondary:   Changes in Safety Parameters Related to Treatment   [ Time Frame: until week 144 ]

38.  Secondary:   Occurence of Rashes   [ Time Frame: 144 weeks ]

39.  Secondary:   Occurence of Hepatic Events   [ Time Frame: 144 weeks ]

40.  Secondary:   New AIDS or AIDS-related Progression Event or Death   [ Time Frame: 144 weeks ]

41.  Secondary:   Time to Loss of Virologic Response   [ Time Frame: 48 weeks ]

42.  Secondary:   Genotypic Resistance Associated With Virologic Failure   [ Time Frame: 48 weeks ]

43.  Secondary:   Trough Plasma Concentration   [ Time Frame: Day 1 to week 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00819052     History of Changes
Other Study ID Numbers: 1100.1526
2008-004681-55 ( EudraCT Number: EudraCT )
First Submitted: January 7, 2009
First Posted: January 8, 2009
Results First Submitted: December 13, 2011
Results First Posted: February 24, 2012
Last Update Posted: November 10, 2014