HIV Infections Clinical Trial
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)
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.
| Status | Completed |
| Enrollment | 1068 |
| Est. completion date | |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 1100.1486.5401 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 | 1100.1486.5407 Boehringer Ingelheim Investigational Site | Capital Federal | |
| Argentina | 1100.1486.5408 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 | |
| Australia | 1100.1486.6103 Boehringer Ingelheim Investigational Site | Brisbane | Queensland |
| Australia | 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 |
| 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 | 1100.1486.3203 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 1100.1486.3205 Boehringer Ingelheim Investigational Site | Bruxelles | |
| Belgium | 1100.1486.3209 Boehringer Ingelheim Investigational Site | Charleroi | |
| Belgium | 1100.1486.3202 Boehringer Ingelheim Investigational Site | Gent | |
| Belgium | 1100.1486.3204 Boehringer Ingelheim Investigational Site | Liège | |
| Belgium | 1100.1486.3206 Boehringer Ingelheim Investigational Site | Liège | |
| Botswana | 1100.1486.2605 Boehringer Ingelheim Investigational Site | Francistown | |
| Botswana | 1100.1486.2601 Boehringer Ingelheim Investigational Site | Gaborone | |
| Botswana | 1100.1486.2603 Boehringer Ingelheim Investigational Site | Gaborone | |
| Canada | 1100.1486.1005 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1100.1486.1010 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1100.1486.1014 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1100.1486.1011 Boehringer Ingelheim Investigational Site | Quebec (Ste Foy) | Quebec |
| Canada | 1100.1486.1013 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1100.1486.1016 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1100.1486.1002 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Canada | 1100.1486.1004 Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba |
| 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 | 1100.1486.3308A Boehringer Ingelheim Investigational Site | Lyon Cedex 3 | |
| France | 1100.1486.3308C Boehringer Ingelheim Investigational Site | Lyon Cedex 3 | |
| France | 1100.1486.3301A Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301B Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301C Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301D Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301E Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301F Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301G Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301H Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3301I Boehringer Ingelheim Investigational Site | Nantes | |
| France | 1100.1486.3306A Boehringer Ingelheim Investigational Site | Nice cedex 3 | |
| France | 1100.1486.3303A Boehringer Ingelheim Investigational Site | Paris | |
| France | 1100.1486.3303B Boehringer Ingelheim Investigational Site | Paris | |
| France | 1100.1486.3303C Boehringer Ingelheim Investigational Site | Paris | |
| France | 1100.1486.3303D Boehringer Ingelheim Investigational Site | Paris | |
| France | 1100.1486.3312A Boehringer Ingelheim Investigational Site | Paris | |
| France | 1100.1486.3312B Boehringer Ingelheim Investigational Site | Paris | |
| France | 1100.1486.3309A Boehringer Ingelheim Investigational Site | Saint Etienne | |
| France | 1100.1486.3309B Boehringer Ingelheim Investigational Site | Saint Etienne | |
| France | 1100.1486.3318A 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 | 1100.1486.3318D Boehringer Ingelheim Investigational Site | Toulon cedex | |
| France | 1100.1486.3302A Boehringer Ingelheim Investigational Site | Toulouse cedex 9 | |
| France | 1100.1486.3302B Boehringer Ingelheim Investigational Site | Toulouse cedex 9 | |
| France | 1100.1486.3302C Boehringer Ingelheim Investigational Site | Toulouse cedex 9 | |
| France | 1100.1486.3310A Boehringer Ingelheim Investigational Site | Villeneuve St Georges cedex | |
| Germany | 1100.1486.4902 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1100.1486.4928 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 | 1100.1486.4916 Boehringer Ingelheim Investigational Site | Frankfurt/Main | |
| Germany | 1100.1486.4929 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 | 1100.1486.4909 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1100.1486.4920 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1100.1486.4925 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1100.1486.4915 Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | 1100.1486.4923 Boehringer Ingelheim Investigational Site | Hannover | |
| Germany | 1100.1486.4910 Boehringer Ingelheim Investigational Site | Kiel | |
| Germany | 1100.1486.4907 Boehringer Ingelheim Investigational Site | Köln | |
| Germany | 1100.1486.4924 Boehringer Ingelheim Investigational Site | Köln | |
| Germany | 1100.1486.4927 Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | 1100.1486.4903 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1100.1486.4904 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1100.1486.4912 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 | |
| Ireland | 1100.1486.3532 Boehringer Ingelheim Investigational Site | Dublin | |
| Ireland | 1100.1486.3531 Boehringer Ingelheim Investigational Site | Dublin 8 | |
| 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 | |
| Mexico | 1100.1486.5207 Boehringer Ingelheim Investigational Site | Guadalajara | |
| Mexico | 1100.1486.5204 Boehringer Ingelheim Investigational Site | León | |
| 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 | |
| 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 | |
| Portugal | 1100.1486.3503 Boehringer Ingelheim Investigational Site | Amadora | |
| Portugal | 1100.1486.3501 Boehringer Ingelheim Investigational Site | Lisboa | |
| Portugal | 1100.1486.3504 Boehringer Ingelheim Investigational Site | Lisboa | |
| Puerto Rico | 1100.1486.0024 Boehringer Ingelheim Investigational Site | Ponce | |
| Puerto Rico | 1100.1486.0033 Boehringer Ingelheim Investigational Site | San Juan | |
| Romania | 1100.1486.4001 Boehringer Ingelheim Investigational Site | Bucharest | |
| Romania | 1100.1486.4002 Boehringer Ingelheim Investigational Site | Bucharest | |
| Russian Federation | 1100.1486.7002 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1100.1486.7001 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| South Africa | 1100.1486.2707 Boehringer Ingelheim Investigational Site | Bloemfontein | |
| South Africa | 1100.1486.2712 Boehringer Ingelheim Investigational Site | Bloemfontein | |
| South Africa | 1100.1486.2703 Boehringer Ingelheim Investigational Site | Cape Town | |
| South Africa | 1100.1486.2709 Boehringer Ingelheim Investigational Site | Cape Town | |
| South Africa | 1100.1486.2711 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 | |
| Spain | 1100.1486.3406 Boehringer Ingelheim Investigational Site | Alcalá de Henares (Madrid) | |
| Spain | 1100.1486.3401 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1100.1486.3402 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1100.1486.3410 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1100.1486.3415 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1100.1486.3417 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1100.1486.3404 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | |
| Spain | 1100.1486.3403 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1100.1486.3405 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1100.1486.3407 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1100.1486.3414 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1100.1486.3416 Boehringer Ingelheim Investigational Site | Mataro | |
| Spain | 1100.1486.3408 Boehringer Ingelheim Investigational Site | Valencia | |
| 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 | |
| United Kingdom | 1100.1486.4406 Boehringer Ingelheim Investigational Site | Birmingham | |
| United Kingdom | 1100.1486.4403 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1100.1486.4404 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1100.1486.4405 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 States | 1100.1486.0005 Boehringer Ingelheim Investigational Site | Akron | Ohio |
| United States | 1100.1486.0046 Boehringer Ingelheim Investigational Site | Annandale | Virginia |
| United States | 1100.1486.0031 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 1100.1486.0004 Boehringer Ingelheim Investigational Site | Austin | Texas |
| United States | 1100.1486.0017 Boehringer Ingelheim Investigational Site | Bakersfield | California |
| United States | 1100.1486.0019 Boehringer Ingelheim Investigational Site | Berkley | Michigan |
| United States | 1100.1486.0001 Boehringer Ingelheim Investigational Site | Beverly Hills | California |
| United States | 1100.1486.0057 Boehringer Ingelheim Investigational Site | Beverly Hills | California |
| United States | 1100.1486.0059 Boehringer Ingelheim Investigational Site | Beverly Hills | California |
| United States | 1100.1486.0040 Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | 1100.1486.0053 Boehringer Ingelheim Investigational Site | Boise | Idaho |
| United States | 1100.1486.0055 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
| United States | 1100.1486.0002 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1100.1486.0026 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1100.1486.0037 Boehringer Ingelheim Investigational Site | Clearwater | Florida |
| United States | 1100.1486.0018 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1100.1486.0038 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1100.1486.0043 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida |
| 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 | 1100.1486.0003 Boehringer Ingelheim Investigational Site | Huntersville | North Carolina |
| United States | 1100.1486.0006 Boehringer Ingelheim Investigational Site | Kansas City | Missouri |
| United States | 1100.1486.0020 Boehringer Ingelheim Investigational Site | Lexington | Kentucky |
| United States | 1100.1486.0035 Boehringer Ingelheim Investigational Site | Long Beach | California |
| United States | 1100.1486.0025 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1100.1486.0034 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1100.1486.0041 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1100.1486.0010 Boehringer Ingelheim Investigational Site | Macon | Georgia |
| 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 | 1100.1486.0013 Boehringer Ingelheim Investigational Site | Phoenix | Arizona |
| 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 | 1100.1486.0027 Boehringer Ingelheim Investigational Site | St. Louis | Missouri |
| United States | 1100.1486.0050 Boehringer Ingelheim Investigational Site | Vero Beach | Florida |
| United States | 1100.1486.0023 Boehringer Ingelheim Investigational Site | Washington | District of Columbia |
| United States | 1100.1486.0029 Boehringer Ingelheim Investigational Site | Washington | District of Columbia |
| United States | 1100.1486.0048 Boehringer Ingelheim Investigational Site | Washington | District of Columbia |
| United States | 1100.1486.0014 Boehringer Ingelheim Investigational Site | Wilton Manors | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Australia, Belgium, Botswana, Canada, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL | week 48 | No |
| 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 | week 0 to 144 | No | |
| Secondary | Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population | Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL | week 144 | No |
| Secondary | Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population | week 0 to 144 | No | |
| Secondary | Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | No | |
| Secondary | Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population | baseline, week 144 | No | |
| Secondary | Occurrence of Rashes | Frequency of patients with drug related rash events by functional grouping | until last patient completed 144 weeks (up to 193 weeks) | No |
| Secondary | Occurrence of Elevations in Laboratory Measurement by DAIDS Grade | until last patient completed 144 weeks (up to 193 weeks) | No | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication | week 0 to 144 | No | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities | week 0 to 72 | No | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities | week 0 to 72 | No | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events | week 0 to 72 | No | |
| Secondary | Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash | week 0 to 72 | No | |
| Secondary | Relative Bioavailability Trough C_pre,ss,1 | 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. | week 132 | No |
| Secondary | Occurrence of Hepatic Events | Frequency of patients with hepatitis symptoms | until last patient completed 144 weeks (up to 193 weeks) | No |
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||
| Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
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Phase 2 |