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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: nevirapine IR
Drug: nevirapine XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL

  • 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 ] [ Designated as safety issue: No ]
  • Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population [ Time Frame: baseline, week 144 ] [ Designated as safety issue: No ]
  • Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population [ Time Frame: baseline, week 144 ] [ Designated as safety issue: No ]
  • Occurrence of Rashes [ Time Frame: until last patient completed 144 weeks (up to 193 weeks) ] [ Designated as safety issue: No ]
    Frequency of patients with drug related rash events by functional grouping

  • Occurrence of Elevations in Laboratory Measurement by DAIDS Grade [ Time Frame: until last patient completed 144 weeks (up to 193 weeks) ] [ Designated as safety issue: No ]
  • Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication [ Time Frame: week 0 to 144 ] [ Designated as safety issue: No ]
  • Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities [ Time Frame: week 0 to 72 ] [ Designated as safety issue: No ]
  • Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities [ Time Frame: week 0 to 72 ] [ Designated as safety issue: No ]
  • Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events [ Time Frame: week 0 to 72 ] [ Designated as safety issue: No ]
  • Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash [ Time Frame: week 0 to 72 ] [ Designated as safety issue: No ]
  • Relative Bioavailability Trough C_pre,ss,1 [ Time Frame: week 132 ] [ Designated as safety issue: No ]
    Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.

  • Occurrence of Hepatic Events [ Time Frame: until last patient completed 144 weeks (up to 193 weeks) ] [ Designated as safety issue: No ]
    Frequency of patients with hepatitis symptoms


Enrollment: 1068
Study Start Date: November 2007
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nevirapine XR
400 mg QD
Drug: nevirapine XR
400 mg QD
Active Comparator: nevirapine IR
200 mg BID
Drug: nevirapine IR
200 mg BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561925

  Hide Study Locations
Locations
United States, Alabama
1100.1486.0040 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
1100.1486.0013 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
1100.1486.0017 Boehringer Ingelheim Investigational Site
Bakersfield, California, United States
1100.1486.0059 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1100.1486.0057 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1100.1486.0001 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1100.1486.0035 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1100.1486.0041 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1100.1486.0034 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1100.1486.0025 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1100.1486.0032 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
1100.1486.0028 Boehringer Ingelheim Investigational Site
San Diego, California, United States
United States, District of Columbia
1100.1486.0048 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
1100.1486.0029 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
1100.1486.0023 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
United States, Florida
1100.1486.0037 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1100.1486.0043 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1100.1486.0012 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1100.1486.0007 Boehringer Ingelheim Investigational Site
Miami Beach, Florida, United States
1100.1486.0039 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1100.1486.0050 Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
1100.1486.0014 Boehringer Ingelheim Investigational Site
Wilton Manors, Florida, United States
United States, Georgia
1100.1486.0031 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1100.1486.0010 Boehringer Ingelheim Investigational Site
Macon, Georgia, United States
United States, Idaho
1100.1486.0053 Boehringer Ingelheim Investigational Site
Boise, Idaho, United States
United States, Illinois
1100.1486.0026 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1100.1486.0002 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Kentucky
1100.1486.0020 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
United States, Michigan
1100.1486.0019 Boehringer Ingelheim Investigational Site
Berkley, Michigan, United States
United States, Missouri
1100.1486.0006 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
1100.1486.0027 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, North Carolina
1100.1486.0055 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1100.1486.0003 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, United States
United States, Ohio
1100.1486.0005 Boehringer Ingelheim Investigational Site
Akron, Ohio, United States
United States, Texas
1100.1486.0004 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1100.1486.0038 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1100.1486.0018 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1100.1486.0044 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1100.1486.0054 Boehringer Ingelheim Investigational Site
Harlingen, Texas, United States
1100.1486.0009 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, Virginia
1100.1486.0046 Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
Argentina
1100.1486.5401 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5408 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5407 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5402 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5404 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1100.1486.5403 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
1100.1486.5409 Boehringer Ingelheim Investigational Site
Quilmes, Argentina
1100.1486.5405 Boehringer Ingelheim Investigational Site
Rosario, Argentina
Australia, New South Wales
1100.1486.6101 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
1100.1486.6102 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
1100.1486.6104 Boehringer Ingelheim Investigational Site
Surry Hills, New South Wales, Australia
Australia, Queensland
1100.1486.6103 Boehringer Ingelheim Investigational Site
Brisbane, Queensland, Australia
Belgium
1100.1486.3208 Boehringer Ingelheim Investigational Site
Brugge, Belgium
1100.1486.3207 Boehringer Ingelheim Investigational Site
Brussel, Belgium
1100.1486.3201 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1100.1486.3205 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1100.1486.3203 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1100.1486.3209 Boehringer Ingelheim Investigational Site
Charleroi, Belgium
1100.1486.3202 Boehringer Ingelheim Investigational Site
Gent, Belgium
1100.1486.3206 Boehringer Ingelheim Investigational Site
Liège, Belgium
1100.1486.3204 Boehringer Ingelheim Investigational Site
Liège, Belgium
Botswana
1100.1486.2605 Boehringer Ingelheim Investigational Site
Francistown, Botswana
1100.1486.2603 Boehringer Ingelheim Investigational Site
Gaborone, Botswana
1100.1486.2601 Boehringer Ingelheim Investigational Site
Gaborone, Botswana
Canada, British Columbia
1100.1486.1002 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Manitoba
1100.1486.1004 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, Ontario
1100.1486.1016 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1100.1486.1013 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1100.1486.1014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1100.1486.1010 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1100.1486.1005 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1100.1486.1011 Boehringer Ingelheim Investigational Site
Quebec (Ste Foy), Quebec, Canada
France
1100.1486.3305A Boehringer Ingelheim Investigational Site
Angers, France
1100.1486.3305B Boehringer Ingelheim Investigational Site
Angers, France
1100.1486.3307A Boehringer Ingelheim Investigational Site
Bondy, France
1100.1486.3317A Boehringer Ingelheim Investigational Site
Bordeaux Cedex, France
1100.1486.3316A Boehringer Ingelheim Investigational Site
Brest Cedex, France
1100.1486.3316B Boehringer Ingelheim Investigational Site
Brest Cedex, France
1100.1486.3314E Boehringer Ingelheim Investigational Site
Caen cedex 5, France
1100.1486.3304A Boehringer Ingelheim Investigational Site
Clamart, France
1100.1486.3308C Boehringer Ingelheim Investigational Site
Lyon Cedex 3, France
1100.1486.3308A Boehringer Ingelheim Investigational Site
Lyon Cedex 3, France
1100.1486.3301F Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301A Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301E Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301I Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301C Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301G Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301D Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301B Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3301H Boehringer Ingelheim Investigational Site
Nantes, France
1100.1486.3306A Boehringer Ingelheim Investigational Site
Nice cedex 3, France
1100.1486.3312A Boehringer Ingelheim Investigational Site
Paris, France
1100.1486.3303A Boehringer Ingelheim Investigational Site
Paris, France
1100.1486.3312B Boehringer Ingelheim Investigational Site
Paris, France
1100.1486.3303D Boehringer Ingelheim Investigational Site
Paris, France
1100.1486.3303C Boehringer Ingelheim Investigational Site
Paris, France
1100.1486.3303B Boehringer Ingelheim Investigational Site
Paris, France
1100.1486.3309B Boehringer Ingelheim Investigational Site
Saint Etienne, France
1100.1486.3309A Boehringer Ingelheim Investigational Site
Saint Etienne, France
1100.1486.3318D Boehringer Ingelheim Investigational Site
Toulon cedex, France
1100.1486.3318B Boehringer Ingelheim Investigational Site
Toulon cedex, France
1100.1486.3318C Boehringer Ingelheim Investigational Site
Toulon cedex, France
1100.1486.3318A Boehringer Ingelheim Investigational Site
Toulon cedex, France
1100.1486.3302A Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
1100.1486.3302C Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
1100.1486.3302B Boehringer Ingelheim Investigational Site
Toulouse cedex 9, France
1100.1486.3310A Boehringer Ingelheim Investigational Site
Villeneuve St Georges cedex, France
Germany
1100.1486.4928 Boehringer Ingelheim Investigational Site
Berlin, Germany
1100.1486.4902 Boehringer Ingelheim Investigational Site
Berlin, Germany
1100.1486.4932 Boehringer Ingelheim Investigational Site
Bochum, Germany
1100.1486.4922 Boehringer Ingelheim Investigational Site
Bonn, Germany
1100.1486.4911 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1100.1486.4919 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1100.1486.4908 Boehringer Ingelheim Investigational Site
Erlangen, Germany
1100.1486.4906 Boehringer Ingelheim Investigational Site
Essen, Germany
1100.1486.4926 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1100.1486.4929 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
1100.1486.4916 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
1100.1486.4901 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1100.1486.4930 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1100.1486.4920 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1100.1486.4925 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1100.1486.4909 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1100.1486.4923 Boehringer Ingelheim Investigational Site
Hannover, Germany
1100.1486.4915 Boehringer Ingelheim Investigational Site
Hannover, Germany
1100.1486.4910 Boehringer Ingelheim Investigational Site
Kiel, Germany
1100.1486.4924 Boehringer Ingelheim Investigational Site
Köln, Germany
1100.1486.4907 Boehringer Ingelheim Investigational Site
Köln, Germany
1100.1486.4927 Boehringer Ingelheim Investigational Site
Mainz, Germany
1100.1486.4903 Boehringer Ingelheim Investigational Site
München, Germany
1100.1486.4912 Boehringer Ingelheim Investigational Site
München, Germany
1100.1486.4904 Boehringer Ingelheim Investigational Site
München, Germany
1100.1486.4905 Boehringer Ingelheim Investigational Site
Münster, Germany
1100.1486.4918 Boehringer Ingelheim Investigational Site
Osnabrück, Germany
1100.1486.4913 Boehringer Ingelheim Investigational Site
Ulm/Donau, Germany
1100.1486.4914 Boehringer Ingelheim Investigational Site
Würzburg, Germany
Ireland
1100.1486.3532 Boehringer Ingelheim Investigational Site
Dublin, Ireland
1100.1486.3531 Boehringer Ingelheim Investigational Site
Dublin 8, Ireland
Italy
1100.1486.3908 Boehringer Ingelheim Investigational Site
Palermo, Italy
1100.1486.3905 Boehringer Ingelheim Investigational Site
Pescara, Italy
1100.1486.3901 Boehringer Ingelheim Investigational Site
Torino, Italy
1100.1486.3907 Boehringer Ingelheim Investigational Site
Treviso, Italy
1100.1486.3906 Boehringer Ingelheim Investigational Site
Verbania, Italy
Mexico
1100.1486.5207 Boehringer Ingelheim Investigational Site
Guadalajara, Mexico
1100.1486.5204 Boehringer Ingelheim Investigational Site
León, Mexico
Netherlands
1100.1486.3107 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
1100.1486.3103 Boehringer Ingelheim Investigational Site
Arnhem, Netherlands
1100.1486.3101 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
1100.1486.3102 Boehringer Ingelheim Investigational Site
Zwolle, Netherlands
Poland
1100.1486.4803 Boehringer Ingelheim Investigational Site
Bydgoszcz, Poland
1100.1486.4801 Boehringer Ingelheim Investigational Site
Chorzow, Poland
1100.1486.4804 Boehringer Ingelheim Investigational Site
Warsaw, Poland
Portugal
1100.1486.3503 Boehringer Ingelheim Investigational Site
Amadora, Portugal
1100.1486.3504 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1100.1486.3501 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
Puerto Rico
1100.1486.0024 Boehringer Ingelheim Investigational Site
Ponce, Puerto Rico
1100.1486.0033 Boehringer Ingelheim Investigational Site
San Juan, Puerto Rico
Romania
1100.1486.4002 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1100.1486.4001 Boehringer Ingelheim Investigational Site
Bucharest, Romania
Russian Federation
1100.1486.7002 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1100.1486.7001 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
South Africa
1100.1486.2712 Boehringer Ingelheim Investigational Site
Bloemfontein, South Africa
1100.1486.2707 Boehringer Ingelheim Investigational Site
Bloemfontein, South Africa
1100.1486.2711 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1100.1486.2703 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1100.1486.2709 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1100.1486.2701 Boehringer Ingelheim Investigational Site
Edenvale, South Africa
1100.1486.2710 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1100.1486.2706 Boehringer Ingelheim Investigational Site
Nelspruit, South Africa
1100.1486.2702 Boehringer Ingelheim Investigational Site
Port Elizabeth, South Africa
1100.1486.2704 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Spain
1100.1486.3406 Boehringer Ingelheim Investigational Site
Alcalá de Henares (Madrid), Spain
1100.1486.3401 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3417 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3415 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3410 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3402 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1100.1486.3404 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat, Spain
1100.1486.3414 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3407 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3405 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3403 Boehringer Ingelheim Investigational Site
Madrid, Spain
1100.1486.3416 Boehringer Ingelheim Investigational Site
Mataro, Spain
1100.1486.3408 Boehringer Ingelheim Investigational Site
Valencia, Spain
Switzerland
1100.1486.4101 Boehringer Ingelheim Investigational Site
Basel, Switzerland
1100.1486.4109 Boehringer Ingelheim Investigational Site
Bern, Switzerland
1100.1486.4107 Boehringer Ingelheim Investigational Site
Genève, Switzerland
1100.1486.4106 Boehringer Ingelheim Investigational Site
La Chaux-de-Fonds, Switzerland
1100.1486.4104 Boehringer Ingelheim Investigational Site
Lausanne, Switzerland
1100.1486.4102 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
1100.1486.4108 Boehringer Ingelheim Investigational Site
St. Gallen, Switzerland
1100.1486.4110 Boehringer Ingelheim Investigational Site
Zürich, Switzerland
United Kingdom
1100.1486.4406 Boehringer Ingelheim Investigational Site
Birmingham, United Kingdom
1100.1486.4404 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4405 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4403 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4407 Boehringer Ingelheim Investigational Site
London, United Kingdom
1100.1486.4401 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1100.1486.4408 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
1100.1486.4402 Boehringer Ingelheim Investigational Site
Plaistow, London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional 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
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 01, 2014