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  
Unknown                 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  
Unknown                 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  
Number of Participants  
[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


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00561925     History of Changes
Other Study ID Numbers: 1100.1486, 2007-003654-29
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