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:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00819052
First received: January 7, 2009
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: December 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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  
Number of Participants  
[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     51     71  
Male     128     244     372  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     0     5     5  
Black     13     20     33  
Hawaiian / Pacific Isle.     1     0     1  
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     70     132     202  
Ex-smoker     36     67     103  
Current smoker     42     96     138  
Alcohol Status  
[units: participants]
     
Non drinker     46     73     119  
Drinks - no interfere with trial     101     216     317  
Drinks - could interfere with trial     1     6     7  



  Outcome Measures
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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 ]


  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


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00819052     History of Changes
Other Study ID Numbers: 1100.1526, 2008-004681-55
Study First Received: January 7, 2009
Results First Received: December 13, 2011
Last Updated: February 24, 2014
Health Authority: France: AFSSAPS
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authorities for Drugs and Medical Products)
Great Britain: MHRA
United States: Food and Drug Administration