Study to compare the efficacy of nevirapine given once daily versus nevirapine given twice daily both in combination with Truvada for the treatment of HIV-infection.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003654-29-DE

Enrollment

958

Registered

2007-09-10

Start date

2007-11-08

Completion date

Unknown

Last updated

2012-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 infection MedDRA version: 14.0 Level: LLT Classification code 10020160 Term: HIV disease System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Nevirapine Tablets, Extended Release, 400 mg Product Code: Nevirapine K25% XR 400 mg Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: NEVIRAPINE CAS Number: 129618402 C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent in accordance with GCP 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 - 50 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. Patients who have successfully completed their week 144 visit of the main trial and given their written informed consent will enter the additional extension phase. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 958 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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/or HBV-DNA-positive or HCV-RNA-positive. Patients who are HBV DNA positive, HBsAg negative and hepatitis surface antibody positive will be allowed into the trial. 3. Female patients of child-bearing potential who: a. have a positive serum pregnancy test at screening, b. are breast feeding, c. are planning to become pregnant, d. are not willing to use a barrier method of contraception, or e. 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. These barrier methods are: diaphragm with spermicide substance, condom for females, cervical caps and condoms. 4. Laboratory parameters >DAIDS Grade 2 However patients with DAIDs Grade 3 for the following laboratory parameters will be allowed into the trial: Eosinophils, Total cholesterol, LDL, HDL, Triglycerides, Total protein, Amylase accompanied by a normal lipase. 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 administered with or without an NRTI for the prevention of mother to child transmission at least 6 months prior to enrolment). 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 and who are receiving systemic chemotherapy or are anticipated to receive any therapy during their participation in this trial. 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 8 weeks at screening visit

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. The objective of the additional extension phase is to collect additional data on the long term efficacy and safety of NVP XR.;Secondary Objective: Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR. ;Primary end point(s): The primary endpoint of this study is sustained virologic response through Week 48. A virologic response is defined by two consecutive measurements of VL <50 copies/mL, at least two weeks apart. A sustained virologic response has no virologic rebound or change of ARV therapy* through Week 48. The time window of Week 48 is defined as 48 ± 4 weeks from Day 1 (the day a patient starts treatment). A virologic rebound is defined by two consecutive measurements of VL = 50 copies/mL, at least two weeks apart, after a virologic response. If there is unconfirmed change of VL status (rebound or response) at Week 48, then another measurement two weeks later is necessary to confirm whether the virologic rebound or response has occurred.;Timepoint(s) of evaluation of this end point: after 48 weeks of treatment	—

Measure

Time frame

Main Objective: 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. The objective of the additional extension phase is to collect additional data on the long term efficacy and safety of NVP XR.;Secondary Objective: Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR. ;Primary end point(s): The primary endpoint of this study is sustained virologic response through Week 48. A virologic response is defined by two consecutive measurements of VL <50 copies/mL, at least two weeks apart. A sustained virologic response has no virologic rebound or change of ARV therapy* through Week 48. The time window of Week 48 is defined as 48 ± 4 weeks from Day 1 (the day a patient starts treatment). A virologic rebound is defined by two consecutive measurements of VL = 50 copies/mL, at least two weeks apart, after a virologic response. If there is unconfirmed change of VL status (rebound or response) at Week 48, then another measurement two weeks later is necessary to confirm whether the virologic rebound or response has occurred.;Timepoint(s) of evaluation of this end point: after 48 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Time-to-loss-of-virologic response 2. Virologic response by Week 48 as defined by VL <400 copies/mL 3. Time to virologic response 4. Time to new AIDS or AIDS-related progression event or death. 5. Change from baseline in VL and CD4+ cell count at each visit. 6. Genotypic resistance associated with virologic failure.;Timepoint(s) of evaluation of this end point: 1. from week 48 to week 144 2. after 48 weeks 3. between the start of lead-in period and the first viral load <50 copies/ mL prior to the time when the last enrolled patient is on treatment for 48 weeks 4. throughout the study duration (from start to 144 weeks) 5. at each visit throughout the study 6. throughout the study, whenever virologic failure occurs	—

Measure

Time frame

Secondary end point(s): 1. Time-to-loss-of-virologic response 2. Virologic response by Week 48 as defined by VL <400 copies/mL 3. Time to virologic response 4. Time to new AIDS or AIDS-related progression event or death. 5. Change from baseline in VL and CD4+ cell count at each visit. 6. Genotypic resistance associated with virologic failure.;Timepoint(s) of evaluation of this end point: 1. from week 48 to week 144 2. after 48 weeks 3. between the start of lead-in period and the first viral load <50 copies/ mL prior to the time when the last enrolled patient is on treatment for 48 weeks 4. throughout the study duration (from start to 144 weeks) 5. at each visit throughout the study 6. throughout the study, whenever virologic failure occurs

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Countries

Argentina, Australia, Belgium, Botswana, Canada, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026