Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00561925




Registration number
NCT00561925
Ethics application status
Date submitted
20/11/2007
Date registered
21/11/2007
Date last updated
7/04/2014

Titles & IDs
Public title
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
Scientific title
A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)
Secondary ID [1] 0 0
2007-003654-29
Secondary ID [2] 0 0
1100.1486
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - nevirapine IR
Treatment: Drugs - nevirapine XR

Experimental: nevirapine XR - 400 mg QD

Active comparator: nevirapine IR - 200 mg BID


Treatment: Drugs: nevirapine IR
200 mg BID

Treatment: Drugs: nevirapine XR
400 mg QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Timepoint [1] 0 0
week 48
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
week 0 to 144
Secondary outcome [2] 0 0
Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Timepoint [2] 0 0
week 144
Secondary outcome [3] 0 0
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Timepoint [3] 0 0
week 0 to 144
Secondary outcome [4] 0 0
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
Timepoint [4] 0 0
baseline, week 144
Secondary outcome [5] 0 0
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
Timepoint [5] 0 0
baseline, week 144
Secondary outcome [6] 0 0
Occurrence of Rashes
Timepoint [6] 0 0
until last patient completed 144 weeks (up to 193 weeks)
Secondary outcome [7] 0 0
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
Timepoint [7] 0 0
until last patient completed 144 weeks (up to 193 weeks)
Secondary outcome [8] 0 0
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Timepoint [8] 0 0
week 0 to 144
Secondary outcome [9] 0 0
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Timepoint [9] 0 0
week 0 to 72
Secondary outcome [10] 0 0
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Timepoint [10] 0 0
week 0 to 72
Secondary outcome [11] 0 0
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Timepoint [11] 0 0
week 0 to 72
Secondary outcome [12] 0 0
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Timepoint [12] 0 0
week 0 to 72
Secondary outcome [13] 0 0
Relative Bioavailability Trough C_pre,ss,1
Timepoint [13] 0 0
week 132
Secondary outcome [14] 0 0
Occurrence of Hepatic Events
Timepoint [14] 0 0
until last patient completed 144 weeks (up to 193 weeks)

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation
2. HIV-1 infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot
3. No previous antiretroviral treatment
4. Males with CD4+ counts >50 - <400 cells/ml or females with CD4+ counts >50-<250 cells/ml
5. Adequate renal function defined as a calculated creatinine clearance (CLCr) greater than or equal to 50 mL/min according to the Cockcroft-Gault formula as follows:

Male: (140 - age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min).

Female: (140 - age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min).
6. Karnofsky score >70 (see Appendix 10.4)
7. An HIV-1 viral load of 1,000 copies/mL
8. Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2
9. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study.
10. For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy. Refusal to participate in the PK substudy is not an exclusion criterion for participation in the trial. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Active drug abuse or chronic alcoholism at the investigator's discretion
2. Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive
3. Female patients of child-bearing potential who: are pregnant at screening; are breast feeding; are planning to become pregnant; are not willing to use a barrier method of contraception, or; are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives Note: During participation in this study, females and males have to use barrier methods of contraception in addition or instead of ethinyl estradiol containing oral contraceptives.
4. Laboratory parameters >DAIDS Grade 2
5. ALT/AST > DAIDS Grade 1
6. Hypersensitivity to any ingredients of the test products
7. Previous use of Viramune® (nevirapine) or any other antiretroviral agents (does not include use of single dose NVP for the prevention of mother to child transmission)
8. Resistance to NNRTIs or either one of the components of Truvada® (emtricitabine or tenofovir disoproxil fumarate) or lamivudine (3TC) based on HIV-1 genotypic resistance testing report obtained at screening
9. Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
10. Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
11. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
12. Patients who have been diagnosed with malignant disease
13. Patients who in the opinion of the investigator are not candidates for inclusion in the study
14. Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
15. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
1068
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
1100.1486.6101 Boehringer Ingelheim Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
1100.1486.6102 Boehringer Ingelheim Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
1100.1486.6104 Boehringer Ingelheim Investigational Site - Surry Hills
Recruitment hospital [4] 0 0
1100.1486.6103 Boehringer Ingelheim Investigational Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Surry Hills
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Capital Federal
Country [17] 0 0
Argentina
State/province [17] 0 0
Mar del Plata
Country [18] 0 0
Argentina
State/province [18] 0 0
Quilmes
Country [19] 0 0
Argentina
State/province [19] 0 0
Rosario
Country [20] 0 0
Belgium
State/province [20] 0 0
Brugge
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussel
Country [22] 0 0
Belgium
State/province [22] 0 0
Bruxelles
Country [23] 0 0
Belgium
State/province [23] 0 0
Charleroi
Country [24] 0 0
Belgium
State/province [24] 0 0
Gent
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Botswana
State/province [26] 0 0
Francistown
Country [27] 0 0
Botswana
State/province [27] 0 0
Gaborone
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Manitoba
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
France
State/province [32] 0 0
Angers
Country [33] 0 0
France
State/province [33] 0 0
Bondy
Country [34] 0 0
France
State/province [34] 0 0
Bordeaux Cedex
Country [35] 0 0
France
State/province [35] 0 0
Brest Cedex
Country [36] 0 0
France
State/province [36] 0 0
Caen cedex 5
Country [37] 0 0
France
State/province [37] 0 0
Clamart
Country [38] 0 0
France
State/province [38] 0 0
Lyon Cedex 3
Country [39] 0 0
France
State/province [39] 0 0
Nantes
Country [40] 0 0
France
State/province [40] 0 0
Nice cedex 3
Country [41] 0 0
France
State/province [41] 0 0
Paris
Country [42] 0 0
France
State/province [42] 0 0
Saint Etienne
Country [43] 0 0
France
State/province [43] 0 0
Toulon cedex
Country [44] 0 0
France
State/province [44] 0 0
Toulouse cedex 9
Country [45] 0 0
France
State/province [45] 0 0
Villeneuve St Georges cedex
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
Country [47] 0 0
Germany
State/province [47] 0 0
Bochum
Country [48] 0 0
Germany
State/province [48] 0 0
Bonn
Country [49] 0 0
Germany
State/province [49] 0 0
Dortmund
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Germany
State/province [50] 0 0
Düsseldorf
Country [51] 0 0
Germany
State/province [51] 0 0
Erlangen
Country [52] 0 0
Germany
State/province [52] 0 0
Essen
Country [53] 0 0
Germany
State/province [53] 0 0
Frankfurt/Main
Country [54] 0 0
Germany
State/province [54] 0 0
Frankfurt
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Germany
State/province [55] 0 0
Freiburg
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Germany
State/province [56] 0 0
Hamburg
Country [57] 0 0
Germany
State/province [57] 0 0
Hannover
Country [58] 0 0
Germany
State/province [58] 0 0
Kiel
Country [59] 0 0
Germany
State/province [59] 0 0
Köln
Country [60] 0 0
Germany
State/province [60] 0 0
Mainz
Country [61] 0 0
Germany
State/province [61] 0 0
München
Country [62] 0 0
Germany
State/province [62] 0 0
Münster
Country [63] 0 0
Germany
State/province [63] 0 0
Osnabrück
Country [64] 0 0
Germany
State/province [64] 0 0
Ulm/Donau
Country [65] 0 0
Germany
State/province [65] 0 0
Würzburg
Country [66] 0 0
Ireland
State/province [66] 0 0
Dublin 8
Country [67] 0 0
Ireland
State/province [67] 0 0
Dublin
Country [68] 0 0
Italy
State/province [68] 0 0
Palermo
Country [69] 0 0
Italy
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Pescara
Country [70] 0 0
Italy
State/province [70] 0 0
Torino
Country [71] 0 0
Italy
State/province [71] 0 0
Treviso
Country [72] 0 0
Italy
State/province [72] 0 0
Verbania
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Mexico
State/province [73] 0 0
Guadalajara
Country [74] 0 0
Mexico
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León
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Netherlands
State/province [75] 0 0
Amsterdam
Country [76] 0 0
Netherlands
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Arnhem
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Netherlands
State/province [77] 0 0
Rotterdam
Country [78] 0 0
Netherlands
State/province [78] 0 0
Zwolle
Country [79] 0 0
Poland
State/province [79] 0 0
Bydgoszcz
Country [80] 0 0
Poland
State/province [80] 0 0
Chorzow
Country [81] 0 0
Poland
State/province [81] 0 0
Warsaw
Country [82] 0 0
Portugal
State/province [82] 0 0
Amadora
Country [83] 0 0
Portugal
State/province [83] 0 0
Lisboa
Country [84] 0 0
Puerto Rico
State/province [84] 0 0
Ponce
Country [85] 0 0
Puerto Rico
State/province [85] 0 0
San Juan
Country [86] 0 0
Romania
State/province [86] 0 0
Bucharest
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Moscow
Country [88] 0 0
Russian Federation
State/province [88] 0 0
St. Petersburg
Country [89] 0 0
South Africa
State/province [89] 0 0
Bloemfontein
Country [90] 0 0
South Africa
State/province [90] 0 0
Cape Town
Country [91] 0 0
South Africa
State/province [91] 0 0
Edenvale
Country [92] 0 0
South Africa
State/province [92] 0 0
Johannesburg
Country [93] 0 0
South Africa
State/province [93] 0 0
Nelspruit
Country [94] 0 0
South Africa
State/province [94] 0 0
Port Elizabeth
Country [95] 0 0
South Africa
State/province [95] 0 0
Pretoria
Country [96] 0 0
Spain
State/province [96] 0 0
Alcalá de Henares (Madrid)
Country [97] 0 0
Spain
State/province [97] 0 0
Barcelona
Country [98] 0 0
Spain
State/province [98] 0 0
L'Hospitalet de Llobregat
Country [99] 0 0
Spain
State/province [99] 0 0
Madrid
Country [100] 0 0
Spain
State/province [100] 0 0
Mataro
Country [101] 0 0
Spain
State/province [101] 0 0
Valencia
Country [102] 0 0
Switzerland
State/province [102] 0 0
Basel
Country [103] 0 0
Switzerland
State/province [103] 0 0
Bern
Country [104] 0 0
Switzerland
State/province [104] 0 0
Genève
Country [105] 0 0
Switzerland
State/province [105] 0 0
La Chaux-de-Fonds
Country [106] 0 0
Switzerland
State/province [106] 0 0
Lausanne
Country [107] 0 0
Switzerland
State/province [107] 0 0
Lugano
Country [108] 0 0
Switzerland
State/province [108] 0 0
St. Gallen
Country [109] 0 0
Switzerland
State/province [109] 0 0
Zürich
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Birmingham
Country [111] 0 0
United Kingdom
State/province [111] 0 0
London
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Manchester
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Plaistow, London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00561925