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)
- NCT00561925
- PHASE3
- INTERVENTIONAL
Last updated: 2014-04-07
Purpose of Trial
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.
This study is for people with
HIV Infections
Interventions being studied
nevirapine IR
nevirapine XR
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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
41 Locations
Birmingham
1100.1486.0040 Boehringer Ingelheim Investigational Site
Alabama, United States
Phoenix
1100.1486.0013 Boehringer Ingelheim Investigational Site
Arizona, United States
Bakersfield
1100.1486.0017 Boehringer Ingelheim Investigational Site
California, United States
Beverly Hills
1100.1486.0001 Boehringer Ingelheim Investigational Site
California, United States
Beverly Hills
1100.1486.0057 Boehringer Ingelheim Investigational Site
California, United States
Beverly Hills
1100.1486.0059 Boehringer Ingelheim Investigational Site
California, United States
Long Beach
1100.1486.0035 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1100.1486.0025 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1100.1486.0034 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1100.1486.0041 Boehringer Ingelheim Investigational Site
California, United States
Sacramento
1100.1486.0032 Boehringer Ingelheim Investigational Site
California, United States
San Diego
1100.1486.0028 Boehringer Ingelheim Investigational Site
California, United States
Washington
1100.1486.0023 Boehringer Ingelheim Investigational Site
District of Columbia, United States
Washington
1100.1486.0029 Boehringer Ingelheim Investigational Site
District of Columbia, United States
Washington
1100.1486.0048 Boehringer Ingelheim Investigational Site
District of Columbia, United States
Clearwater
1100.1486.0037 Boehringer Ingelheim Investigational Site
Florida, United States
Fort Lauderdale
1100.1486.0043 Boehringer Ingelheim Investigational Site
Florida, United States
Miami Beach
1100.1486.0007 Boehringer Ingelheim Investigational Site
Florida, United States
Miami
1100.1486.0012 Boehringer Ingelheim Investigational Site
Florida, United States
Orlando
1100.1486.0039 Boehringer Ingelheim Investigational Site
Florida, United States
Vero Beach
1100.1486.0050 Boehringer Ingelheim Investigational Site
Florida, United States
Wilton Manors
1100.1486.0014 Boehringer Ingelheim Investigational Site
Florida, United States
Atlanta
1100.1486.0031 Boehringer Ingelheim Investigational Site
Georgia, United States
Macon
1100.1486.0010 Boehringer Ingelheim Investigational Site
Georgia, United States
Boise
1100.1486.0053 Boehringer Ingelheim Investigational Site
Idaho, United States
Chicago
1100.1486.0002 Boehringer Ingelheim Investigational Site
Illinois, United States
Chicago
1100.1486.0026 Boehringer Ingelheim Investigational Site
Illinois, United States
Lexington
1100.1486.0020 Boehringer Ingelheim Investigational Site
Kentucky, United States
Berkley
1100.1486.0019 Boehringer Ingelheim Investigational Site
Michigan, United States
Kansas City
1100.1486.0006 Boehringer Ingelheim Investigational Site
Missouri, United States
St. Louis
1100.1486.0027 Boehringer Ingelheim Investigational Site
Missouri, United States
Charlotte
1100.1486.0055 Boehringer Ingelheim Investigational Site
North Carolina, United States
Huntersville
1100.1486.0003 Boehringer Ingelheim Investigational Site
North Carolina, United States
Akron
1100.1486.0005 Boehringer Ingelheim Investigational Site
Ohio, United States
Austin
1100.1486.0004 Boehringer Ingelheim Investigational Site
Texas, United States
Dallas
1100.1486.0018 Boehringer Ingelheim Investigational Site
Texas, United States
Dallas
1100.1486.0038 Boehringer Ingelheim Investigational Site
Texas, United States
Fort Worth
1100.1486.0044 Boehringer Ingelheim Investigational Site
Texas, United States
Harlingen
1100.1486.0054 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1100.1486.0009 Boehringer Ingelheim Investigational Site
Texas, United States
Annandale
1100.1486.0046 Boehringer Ingelheim Investigational Site
Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov