Clinical trial NCT00561925: VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 1068
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.


Eligibility 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.

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

Primary outcomes:
measure: Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
timeFrame: week 48
Secondary outcomes:
measure: 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
timeFrame: week 0 to 144
measure: Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
timeFrame: week 144
measure: Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
timeFrame: week 0 to 144
measure: Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
timeFrame: baseline, week 144
measure: Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
timeFrame: baseline, week 144
measure: Occurrence of Rashes
timeFrame: until last patient completed 144 weeks (up to 193 weeks)
measure: Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
timeFrame: until last patient completed 144 weeks (up to 193 weeks)
measure: Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
timeFrame: week 0 to 144
measure: Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
timeFrame: week 0 to 72
measure: Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
timeFrame: week 0 to 72
measure: Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
timeFrame: week 0 to 72
measure: Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
timeFrame: week 0 to 72
measure: Relative Bioavailability Trough C_pre,ss,1
timeFrame: week 132
measure: Occurrence of Hepatic Events
timeFrame: until last patient completed 144 weeks (up to 193 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1100.1486.0040 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 1100.1486.0013 Boehringer Ingelheim Investigational Site
state: Arizona
city: Bakersfield
country: United States
facility: 1100.1486.0017 Boehringer Ingelheim Investigational Site
state: California
city: Beverly Hills
country: United States
facility: 1100.1486.0001 Boehringer Ingelheim Investigational Site
state: California
city: Beverly Hills
country: United States
facility: 1100.1486.0057 Boehringer Ingelheim Investigational Site
state: California
city: Beverly Hills
country: United States
facility: 1100.1486.0059 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1100.1486.0035 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1100.1486.0025 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1100.1486.0034 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1100.1486.0041 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 1100.1486.0032 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1100.1486.0028 Boehringer Ingelheim Investigational Site
state: California
city: Washington
country: United States
facility: 1100.1486.0023 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: 1100.1486.0029 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: 1100.1486.0048 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Clearwater
country: United States
facility: 1100.1486.0037 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 1100.1486.0043 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: 1100.1486.0007 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1100.1486.0012 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 1100.1486.0039 Boehringer Ingelheim Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: 1100.1486.0050 Boehringer Ingelheim Investigational Site
state: Florida
city: Wilton Manors
country: United States
facility: 1100.1486.0014 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1100.1486.0031 Boehringer Ingelheim Investigational Site
state: Georgia
city: Macon
country: United States
facility: 1100.1486.0010 Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: 1100.1486.0053 Boehringer Ingelheim Investigational Site
state: Idaho
city: Chicago
country: United States
facility: 1100.1486.0002 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1100.1486.0026 Boehringer Ingelheim Investigational Site
state: Illinois
city: Lexington
country: United States
facility: 1100.1486.0020 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Berkley
country: United States
facility: 1100.1486.0019 Boehringer Ingelheim Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: 1100.1486.0006 Boehringer Ingelheim Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: 1100.1486.0027 Boehringer Ingelheim Investigational Site
state: Missouri
city: Charlotte
country: United States
facility: 1100.1486.0055 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: 1100.1486.0003 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Akron
country: United States
facility: 1100.1486.0005 Boehringer Ingelheim Investigational Site
state: Ohio
city: Austin
country: United States
facility: 1100.1486.0004 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1100.1486.0018 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1100.1486.0038 Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: 1100.1486.0044 Boehringer Ingelheim Investigational Site
state: Texas
city: Harlingen
country: United States
facility: 1100.1486.0054 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1100.1486.0009 Boehringer Ingelheim Investigational Site
state: Texas
city: Annandale
country: United States
facility: 1100.1486.0046 Boehringer Ingelheim Investigational Site
state: Virginia
city: Capital Federal
country: Argentina
facility: 1100.1486.5401 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1100.1486.5402 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1100.1486.5404 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1100.1486.5407 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1100.1486.5408 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1100.1486.5403 Boehringer Ingelheim Investigational Site
city: Quilmes
country: Argentina
facility: 1100.1486.5409 Boehringer Ingelheim Investigational Site
city: Rosario
country: Argentina
facility: 1100.1486.5405 Boehringer Ingelheim Investigational Site
city: Darlinghurst
country: Australia
facility: 1100.1486.6101 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: 1100.1486.6102 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Surry Hills
country: Australia
facility: 1100.1486.6104 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Brisbane
country: Australia
facility: 1100.1486.6103 Boehringer Ingelheim Investigational Site
state: Queensland
city: Brugge
country: Belgium
facility: 1100.1486.3208 Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: 1100.1486.3207 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1100.1486.3201 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1100.1486.3203 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1100.1486.3205 Boehringer Ingelheim Investigational Site
city: Charleroi
country: Belgium
facility: 1100.1486.3209 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1100.1486.3202 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1100.1486.3204 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1100.1486.3206 Boehringer Ingelheim Investigational Site
city: Francistown
country: Botswana
facility: 1100.1486.2605 Boehringer Ingelheim Investigational Site
city: Gaborone
country: Botswana
facility: 1100.1486.2601 Boehringer Ingelheim Investigational Site
city: Gaborone
country: Botswana
facility: 1100.1486.2603 Boehringer Ingelheim Investigational Site
city: Vancouver
country: Canada
facility: 1100.1486.1002 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1100.1486.1004 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Toronto
country: Canada
facility: 1100.1486.1013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1100.1486.1016 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1100.1486.1005 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1100.1486.1010 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1100.1486.1014 Boehringer Ingelheim Investigational Site
state: Quebec
city: Quebec (Ste Foy)
country: Canada
facility: 1100.1486.1011 Boehringer Ingelheim Investigational Site
state: Quebec
city: Angers
country: France
facility: 1100.1486.3305A Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 1100.1486.3305B Boehringer Ingelheim Investigational Site
city: Bondy
country: France
facility: 1100.1486.3307A Boehringer Ingelheim Investigational Site
city: Bordeaux Cedex
country: France
facility: 1100.1486.3317A Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1100.1486.3316A Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1100.1486.3316B Boehringer Ingelheim Investigational Site
city: Caen cedex 5
country: France
facility: 1100.1486.3314E Boehringer Ingelheim Investigational Site
city: Clamart
country: France
facility: 1100.1486.3304A Boehringer Ingelheim Investigational Site
city: Lyon Cedex 3
country: France
facility: 1100.1486.3308A Boehringer Ingelheim Investigational Site
city: Lyon Cedex 3
country: France
facility: 1100.1486.3308C Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301A Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301C Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301D Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301E Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301F Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301G Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301H Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1100.1486.3301I Boehringer Ingelheim Investigational Site
city: Nice cedex 3
country: France
facility: 1100.1486.3306A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1100.1486.3303A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1100.1486.3303B Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1100.1486.3303C Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1100.1486.3303D Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1100.1486.3312A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 1100.1486.3312B Boehringer Ingelheim Investigational Site
city: Saint Etienne
country: France
facility: 1100.1486.3309A Boehringer Ingelheim Investigational Site
city: Saint Etienne
country: France
facility: 1100.1486.3309B Boehringer Ingelheim Investigational Site
city: Toulon cedex
country: France
facility: 1100.1486.3318A Boehringer Ingelheim Investigational Site
city: Toulon cedex
country: France
facility: 1100.1486.3318B Boehringer Ingelheim Investigational Site
city: Toulon cedex
country: France
facility: 1100.1486.3318C Boehringer Ingelheim Investigational Site
city: Toulon cedex
country: France
facility: 1100.1486.3318D Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 1100.1486.3302A Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 1100.1486.3302B Boehringer Ingelheim Investigational Site
city: Toulouse cedex 9
country: France
facility: 1100.1486.3302C Boehringer Ingelheim Investigational Site
city: Villeneuve St Georges cedex
country: France
facility: 1100.1486.3310A Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1100.1486.4902 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1100.1486.4928 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 1100.1486.4932 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1100.1486.4922 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1100.1486.4911 Boehringer Ingelheim Investigational Site
city: Düsseldorf
country: Germany
facility: 1100.1486.4919 Boehringer Ingelheim Investigational Site
city: Erlangen
country: Germany
facility: 1100.1486.4908 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1100.1486.4906 Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: 1100.1486.4916 Boehringer Ingelheim Investigational Site
city: Frankfurt/Main
country: Germany
facility: 1100.1486.4929 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1100.1486.4926 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1100.1486.4901 Boehringer Ingelheim Investigational Site
city: Freiburg
country: Germany
facility: 1100.1486.4930 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1100.1486.4909 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1100.1486.4920 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1100.1486.4925 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1100.1486.4915 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1100.1486.4923 Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: 1100.1486.4910 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1100.1486.4907 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1100.1486.4924 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1100.1486.4927 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1100.1486.4903 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1100.1486.4904 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1100.1486.4912 Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: 1100.1486.4905 Boehringer Ingelheim Investigational Site
city: Osnabrück
country: Germany
facility: 1100.1486.4918 Boehringer Ingelheim Investigational Site
city: Ulm/Donau
country: Germany
facility: 1100.1486.4913 Boehringer Ingelheim Investigational Site
city: Würzburg
country: Germany
facility: 1100.1486.4914 Boehringer Ingelheim Investigational Site
city: Dublin 8
country: Ireland
facility: 1100.1486.3531 Boehringer Ingelheim Investigational Site
city: Dublin
country: Ireland
facility: 1100.1486.3532 Boehringer Ingelheim Investigational Site
city: Palermo
country: Italy
facility: 1100.1486.3908 Boehringer Ingelheim Investigational Site
city: Pescara
country: Italy
facility: 1100.1486.3905 Boehringer Ingelheim Investigational Site
city: Torino
country: Italy
facility: 1100.1486.3901 Boehringer Ingelheim Investigational Site
city: Treviso
country: Italy
facility: 1100.1486.3907 Boehringer Ingelheim Investigational Site
city: Verbania
country: Italy
facility: 1100.1486.3906 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1100.1486.5207 Boehringer Ingelheim Investigational Site
city: León
country: Mexico
facility: 1100.1486.5204 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1100.1486.3107 Boehringer Ingelheim Investigational Site
city: Arnhem
country: Netherlands
facility: 1100.1486.3103 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1100.1486.3101 Boehringer Ingelheim Investigational Site
city: Zwolle
country: Netherlands
facility: 1100.1486.3102 Boehringer Ingelheim Investigational Site
city: Bydgoszcz
country: Poland
facility: 1100.1486.4803 Boehringer Ingelheim Investigational Site
city: Chorzow
country: Poland
facility: 1100.1486.4801 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1100.1486.4804 Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: 1100.1486.3503 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1100.1486.3501 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1100.1486.3504 Boehringer Ingelheim Investigational Site
city: Ponce
country: Puerto Rico
facility: 1100.1486.0024 Boehringer Ingelheim Investigational Site
city: San Juan
country: Puerto Rico
facility: 1100.1486.0033 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1100.1486.4001 Boehringer Ingelheim Investigational Site
city: Bucharest
country: Romania
facility: 1100.1486.4002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1100.1486.7002 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1100.1486.7001 Boehringer Ingelheim Investigational Site
city: Bloemfontein
country: South Africa
facility: 1100.1486.2707 Boehringer Ingelheim Investigational Site
city: Bloemfontein
country: South Africa
facility: 1100.1486.2712 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1100.1486.2703 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1100.1486.2709 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1100.1486.2711 Boehringer Ingelheim Investigational Site
city: Edenvale
country: South Africa
facility: 1100.1486.2701 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1100.1486.2710 Boehringer Ingelheim Investigational Site
city: Nelspruit
country: South Africa
facility: 1100.1486.2706 Boehringer Ingelheim Investigational Site
city: Port Elizabeth
country: South Africa
facility: 1100.1486.2702 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1100.1486.2704 Boehringer Ingelheim Investigational Site
city: Alcalá de Henares (Madrid)
country: Spain
facility: 1100.1486.3406 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1100.1486.3401 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1100.1486.3402 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1100.1486.3410 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1100.1486.3415 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1100.1486.3417 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat
country: Spain
facility: 1100.1486.3404 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1100.1486.3403 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1100.1486.3405 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1100.1486.3407 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1100.1486.3414 Boehringer Ingelheim Investigational Site
city: Mataro
country: Spain
facility: 1100.1486.3416 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1100.1486.3408 Boehringer Ingelheim Investigational Site
city: Basel
country: Switzerland
facility: 1100.1486.4101 Boehringer Ingelheim Investigational Site
city: Bern
country: Switzerland
facility: 1100.1486.4109 Boehringer Ingelheim Investigational Site
city: Genève
country: Switzerland
facility: 1100.1486.4107 Boehringer Ingelheim Investigational Site
city: La Chaux-de-Fonds
country: Switzerland
facility: 1100.1486.4106 Boehringer Ingelheim Investigational Site
city: Lausanne
country: Switzerland
facility: 1100.1486.4104 Boehringer Ingelheim Investigational Site
city: Lugano
country: Switzerland
facility: 1100.1486.4102 Boehringer Ingelheim Investigational Site
city: St. Gallen
country: Switzerland
facility: 1100.1486.4108 Boehringer Ingelheim Investigational Site
city: Zürich
country: Switzerland
facility: 1100.1486.4110 Boehringer Ingelheim Investigational Site
city: Birmingham
country: United Kingdom
facility: 1100.1486.4406 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1100.1486.4403 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1100.1486.4404 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1100.1486.4405 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1100.1486.4407 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1100.1486.4401 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1100.1486.4408 Boehringer Ingelheim Investigational Site
city: Plaistow, London
country: United Kingdom
facility: 1100.1486.4402 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Gathe J, Andrade-Villanueva J, Santiago S, Horban A, Nelson M, Cahn P, Bogner J, Spencer D, Podzamczer D, Yong CL, Nguyen T, Zhang W, Drulak M, Quinson AM. Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. Antivir Ther. 2011;16(5):759-69. doi: 10.3851/IMP1803.