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VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00561925
First received: November 20, 2007
Last updated: March 7, 2014
Last verified: March 2014
Results First Received: December 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: nevirapine IR
Drug: nevirapine XR

  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
No text entered.

Reporting Groups
  Description
NVP IR 200mg QD Nevirapine immediate release 200 mg given once daily
NVP IR 200mg BID Nevirapine immediate release 200 mg given twice daily
NVP XR 400mg QD Nevirapine extended release 400 mg given once daily
NVP XR No text entered.
NVP IR to XR No text entered.

Participant Flow for 3 periods

Period 1:   14 Day Lead-In Period
    NVP IR 200mg QD   NVP IR 200mg BID   NVP XR 400mg QD   NVP XR   NVP IR to XR
STARTED   1068   0   0   0   0 
COMPLETED   1013   0   0   0   0 
NOT COMPLETED   55   0   0   0   0 
Adverse Event                38                0                0                0                0 
In/Exclusion criteria                4                0                0                0                0 
Lost to Follow-up                4                0                0                0                0 
Withdrawal by Subject                4                0                0                0                0 
Other                5                0                0                0                0 

Period 2:   144-week Double-blind, Double-dummy
    NVP IR 200mg QD   NVP IR 200mg BID   NVP XR 400mg QD   NVP XR   NVP IR to XR
STARTED   0   508   505   0   0 
COMPLETED   0   358   378   0   0 
NOT COMPLETED   0   150   127   0   0 
Adverse Event                0                48                43                0                0 
Protocol Violation                0                15                9                0                0 
Lost to Follow-up                0                15                12                0                0 
Withdrawal by Subject                0                19                7                0                0 
Lack of Efficacy                0                36                33                0                0 
Pregnancy                0                1                9                0                0 
Death                0                6                3                0                0 
Not treated with study drug                0                2                0                0                0 
Other                0                8                11                0                0 

Period 3:   Open-Label Extension Period
    NVP IR 200mg QD   NVP IR 200mg BID   NVP XR 400mg QD   NVP XR   NVP IR to XR
STARTED   0   1   0   358   378 
COMPLETED   0   1   0   315   328 
NOT COMPLETED   0   0   0   43   50 
Declined entry into extension period                0                0                0                43                50 



  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.
No text entered.

Reporting Groups
  Description
NVP IR 200mg QD Nevirapine immediate release 200 mg tablets given once daily
NVP IR 200mg BID Nevirapine immediate release 200 mg tablets given twice daily
NVP XR 400mg QD Nevirapine extended release 400 mg tablets given once daily
Total Total of all reporting groups

Baseline Measures
   NVP IR 200mg QD   NVP IR 200mg BID   NVP XR 400mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   508   505   1013 
Age 
[Units: Years]
Mean (Standard Deviation)
    38.0  (9.7)   38.3  (9.7)   38.1  (9.7) 
Age, Customized 
[Units: Participants]
       
18 to < 41 years      316   299   615 
41 to < 56 years      165   182   347 
56 to < 65 years      25   19   44 
65 years or more      2   5   7 
Gender 
[Units: Participants]
       
Female      75   74   149 
Male      433   431   864 
Race/Ethnicity, Customized 
[Units: Participants]
       
American Indian / Alaskan Native      6   8   14 
Asian      13   15   28 
Black      113   94   207 
Hawaiian / Pacific Isle.      0   1   1 
White      376   387   763 
Race/Ethnicity, Customized 
[Units: Participants]
       
Hispanic / Latino      109   115   224 
Not Hispanic / Latino      399   390   789 
Region of Enrollment 
[Units: Participants]
       
North America / Australia      149   141   290 
Europe      253   257   510 
Latin America      49   58   107 
Africa      57   49   106 
Smoking History 
[Units: Participants]
       
Never smoked      250   224   474 
Ex-smoker      81   86   167 
Current smoker      177   195   372 
Alcohol Status 
[Units: Participants]
       
Non drinker      151   168   319 
Drinks - no interfere with trial      354   335   689 
Drinks - could interfere with trial      3   2   5 


  Outcome Measures
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1.  Primary:   Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 48 ]

2.  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 144 ]

3.  Secondary:   Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population   [ Time Frame: week 144 ]

4.  Secondary:   Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population   [ Time Frame: week 0 to 144 ]

5.  Secondary:   Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population   [ Time Frame: baseline, week 144 ]

6.  Secondary:   Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population   [ Time Frame: baseline, week 144 ]

7.  Secondary:   Occurrence of Rashes   [ Time Frame: until last patient completed 144 weeks (up to 193 weeks) ]

8.  Secondary:   Occurrence of Elevations in Laboratory Measurement by DAIDS Grade   [ Time Frame: until last patient completed 144 weeks (up to 193 weeks) ]

9.  Secondary:   Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication   [ Time Frame: week 0 to 144 ]

10.  Secondary:   Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities   [ Time Frame: week 0 to 72 ]

11.  Secondary:   Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities   [ Time Frame: week 0 to 72 ]

12.  Secondary:   Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events   [ Time Frame: week 0 to 72 ]

13.  Secondary:   Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash   [ Time Frame: week 0 to 72 ]

14.  Secondary:   Relative Bioavailability Trough C_pre,ss,1   [ Time Frame: week 132 ]

15.  Secondary:   Occurrence of Hepatic Events   [ Time Frame: until last patient completed 144 weeks (up to 193 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
For the lead-in-period with NVP IR 200mg QD, MedDRA Version 12.1 was used for AE/SAE reporting.


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00561925     History of Changes
Other Study ID Numbers: 1100.1486
2007-003654-29 ( EudraCT Number: EudraCT )
Study First Received: November 20, 2007
Results First Received: December 13, 2011
Last Updated: March 7, 2014
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica (A.N.M.A.T.)
Australia: Responsilble Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada (TPD)
France: AFSSAPS
Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)
Great Britain: MHRA
Ireland: Irish Medicines Board
Italy: Comitato Etico Interaziendale delle ASL di Torino
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Republic of Botswana: Ministry of Health Harvard University Research Ethics Commitee
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
South Africa: MCC (Medicines Control Council)
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Switzerland: Swissmedic
United States: Food and Drug Administration