VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID: NCT00561925
Run by: Boehringer Ingelheim
People needed: 1068
Starts: 2007-11-01
Last updated by the study team: 2014-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed informed consent in accordance with Good Clinical Practice and local regulatory requirements prior to trial participation
HIV-1 infected males or females >= 18 years of age with positive serology (ELISA) confirmed by Western blot
No previous antiretroviral treatment
Males with CD4+ counts >50 - <400 cells/ml or females with CD4+ counts >50-<250 cells/ml
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).
Karnofsky score >70 (see Appendix 10.4)
An HIV-1 viral load of 1,000 copies/mL
Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2
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.
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.

You may not qualify if…

Active drug abuse or chronic alcoholism at the investigator's discretion
Active hepatitis B or C disease, defined as HBsAg-positive and HBV-DNA-positive or HCV-RNA-positive
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.
Laboratory parameters >DAIDS Grade 2
ALT/AST > DAIDS Grade 1
Hypersensitivity to any ingredients of the test products
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)
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
Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
Patients who have been diagnosed with malignant disease
Patients who in the opinion of the investigator are not candidates for inclusion in the study
Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit

Where it is running

1100.1486.0013 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
1100.1486.0017 Boehringer Ingelheim Investigational Site — Bakersfield, California, 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
1100.1486.0035 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
1100.1486.0032 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
1100.1486.0028 Boehringer Ingelheim Investigational Site — San Diego, California, United States
1100.1486.0023 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
1100.1486.0029 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
1100.1486.0048 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
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
1100.1486.0031 Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
1100.1486.0010 Boehringer Ingelheim Investigational Site — Macon, Georgia, United States
1100.1486.0053 Boehringer Ingelheim Investigational Site — Boise, Idaho, United States
1100.1486.0040 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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