search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
nevirapine IR
nevirapine XR
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1100.1486.0040 Boehringer Ingelheim Investigational Site
  • 1100.1486.0013 Boehringer Ingelheim Investigational Site
  • 1100.1486.0017 Boehringer Ingelheim Investigational Site
  • 1100.1486.0001 Boehringer Ingelheim Investigational Site
  • 1100.1486.0057 Boehringer Ingelheim Investigational Site
  • 1100.1486.0059 Boehringer Ingelheim Investigational Site
  • 1100.1486.0035 Boehringer Ingelheim Investigational Site
  • 1100.1486.0025 Boehringer Ingelheim Investigational Site
  • 1100.1486.0034 Boehringer Ingelheim Investigational Site
  • 1100.1486.0041 Boehringer Ingelheim Investigational Site
  • 1100.1486.0032 Boehringer Ingelheim Investigational Site
  • 1100.1486.0028 Boehringer Ingelheim Investigational Site
  • 1100.1486.0023 Boehringer Ingelheim Investigational Site
  • 1100.1486.0029 Boehringer Ingelheim Investigational Site
  • 1100.1486.0048 Boehringer Ingelheim Investigational Site
  • 1100.1486.0037 Boehringer Ingelheim Investigational Site
  • 1100.1486.0043 Boehringer Ingelheim Investigational Site
  • 1100.1486.0007 Boehringer Ingelheim Investigational Site
  • 1100.1486.0012 Boehringer Ingelheim Investigational Site
  • 1100.1486.0039 Boehringer Ingelheim Investigational Site
  • 1100.1486.0050 Boehringer Ingelheim Investigational Site
  • 1100.1486.0014 Boehringer Ingelheim Investigational Site
  • 1100.1486.0031 Boehringer Ingelheim Investigational Site
  • 1100.1486.0010 Boehringer Ingelheim Investigational Site
  • 1100.1486.0053 Boehringer Ingelheim Investigational Site
  • 1100.1486.0002 Boehringer Ingelheim Investigational Site
  • 1100.1486.0026 Boehringer Ingelheim Investigational Site
  • 1100.1486.0020 Boehringer Ingelheim Investigational Site
  • 1100.1486.0019 Boehringer Ingelheim Investigational Site
  • 1100.1486.0006 Boehringer Ingelheim Investigational Site
  • 1100.1486.0027 Boehringer Ingelheim Investigational Site
  • 1100.1486.0055 Boehringer Ingelheim Investigational Site
  • 1100.1486.0003 Boehringer Ingelheim Investigational Site
  • 1100.1486.0005 Boehringer Ingelheim Investigational Site
  • 1100.1486.0004 Boehringer Ingelheim Investigational Site
  • 1100.1486.0018 Boehringer Ingelheim Investigational Site
  • 1100.1486.0038 Boehringer Ingelheim Investigational Site
  • 1100.1486.0044 Boehringer Ingelheim Investigational Site
  • 1100.1486.0054 Boehringer Ingelheim Investigational Site
  • 1100.1486.0009 Boehringer Ingelheim Investigational Site
  • 1100.1486.0046 Boehringer Ingelheim Investigational Site
  • 1100.1486.5401 Boehringer Ingelheim Investigational Site
  • 1100.1486.5402 Boehringer Ingelheim Investigational Site
  • 1100.1486.5404 Boehringer Ingelheim Investigational Site
  • 1100.1486.5407 Boehringer Ingelheim Investigational Site
  • 1100.1486.5408 Boehringer Ingelheim Investigational Site
  • 1100.1486.5403 Boehringer Ingelheim Investigational Site
  • 1100.1486.5409 Boehringer Ingelheim Investigational Site
  • 1100.1486.5405 Boehringer Ingelheim Investigational Site
  • 1100.1486.6101 Boehringer Ingelheim Investigational Site
  • 1100.1486.6102 Boehringer Ingelheim Investigational Site
  • 1100.1486.6104 Boehringer Ingelheim Investigational Site
  • 1100.1486.6103 Boehringer Ingelheim Investigational Site
  • 1100.1486.3208 Boehringer Ingelheim Investigational Site
  • 1100.1486.3207 Boehringer Ingelheim Investigational Site
  • 1100.1486.3201 Boehringer Ingelheim Investigational Site
  • 1100.1486.3203 Boehringer Ingelheim Investigational Site
  • 1100.1486.3205 Boehringer Ingelheim Investigational Site
  • 1100.1486.3209 Boehringer Ingelheim Investigational Site
  • 1100.1486.3202 Boehringer Ingelheim Investigational Site
  • 1100.1486.3204 Boehringer Ingelheim Investigational Site
  • 1100.1486.3206 Boehringer Ingelheim Investigational Site
  • 1100.1486.2605 Boehringer Ingelheim Investigational Site
  • 1100.1486.2601 Boehringer Ingelheim Investigational Site
  • 1100.1486.2603 Boehringer Ingelheim Investigational Site
  • 1100.1486.1002 Boehringer Ingelheim Investigational Site
  • 1100.1486.1004 Boehringer Ingelheim Investigational Site
  • 1100.1486.1013 Boehringer Ingelheim Investigational Site
  • 1100.1486.1016 Boehringer Ingelheim Investigational Site
  • 1100.1486.1005 Boehringer Ingelheim Investigational Site
  • 1100.1486.1010 Boehringer Ingelheim Investigational Site
  • 1100.1486.1014 Boehringer Ingelheim Investigational Site
  • 1100.1486.1011 Boehringer Ingelheim Investigational Site
  • 1100.1486.3305A Boehringer Ingelheim Investigational Site
  • 1100.1486.3305B Boehringer Ingelheim Investigational Site
  • 1100.1486.3307A Boehringer Ingelheim Investigational Site
  • 1100.1486.3317A Boehringer Ingelheim Investigational Site
  • 1100.1486.3316A Boehringer Ingelheim Investigational Site
  • 1100.1486.3316B Boehringer Ingelheim Investigational Site
  • 1100.1486.3314E Boehringer Ingelheim Investigational Site
  • 1100.1486.3304A Boehringer Ingelheim Investigational Site
  • 1100.1486.3308A Boehringer Ingelheim Investigational Site
  • 1100.1486.3308C Boehringer Ingelheim Investigational Site
  • 1100.1486.3301A Boehringer Ingelheim Investigational Site
  • 1100.1486.3301B Boehringer Ingelheim Investigational Site
  • 1100.1486.3301C Boehringer Ingelheim Investigational Site
  • 1100.1486.3301D Boehringer Ingelheim Investigational Site
  • 1100.1486.3301E Boehringer Ingelheim Investigational Site
  • 1100.1486.3301F Boehringer Ingelheim Investigational Site
  • 1100.1486.3301G Boehringer Ingelheim Investigational Site
  • 1100.1486.3301H Boehringer Ingelheim Investigational Site
  • 1100.1486.3301I Boehringer Ingelheim Investigational Site
  • 1100.1486.3306A Boehringer Ingelheim Investigational Site
  • 1100.1486.3303A Boehringer Ingelheim Investigational Site
  • 1100.1486.3303B Boehringer Ingelheim Investigational Site
  • 1100.1486.3303C Boehringer Ingelheim Investigational Site
  • 1100.1486.3303D Boehringer Ingelheim Investigational Site
  • 1100.1486.3312A Boehringer Ingelheim Investigational Site
  • 1100.1486.3312B Boehringer Ingelheim Investigational Site
  • 1100.1486.3309A Boehringer Ingelheim Investigational Site
  • 1100.1486.3309B Boehringer Ingelheim Investigational Site
  • 1100.1486.3318A Boehringer Ingelheim Investigational Site
  • 1100.1486.3318B Boehringer Ingelheim Investigational Site
  • 1100.1486.3318C Boehringer Ingelheim Investigational Site
  • 1100.1486.3318D Boehringer Ingelheim Investigational Site
  • 1100.1486.3302A Boehringer Ingelheim Investigational Site
  • 1100.1486.3302B Boehringer Ingelheim Investigational Site
  • 1100.1486.3302C Boehringer Ingelheim Investigational Site
  • 1100.1486.3310A Boehringer Ingelheim Investigational Site
  • 1100.1486.4902 Boehringer Ingelheim Investigational Site
  • 1100.1486.4928 Boehringer Ingelheim Investigational Site
  • 1100.1486.4932 Boehringer Ingelheim Investigational Site
  • 1100.1486.4922 Boehringer Ingelheim Investigational Site
  • 1100.1486.4911 Boehringer Ingelheim Investigational Site
  • 1100.1486.4919 Boehringer Ingelheim Investigational Site
  • 1100.1486.4908 Boehringer Ingelheim Investigational Site
  • 1100.1486.4906 Boehringer Ingelheim Investigational Site
  • 1100.1486.4916 Boehringer Ingelheim Investigational Site
  • 1100.1486.4929 Boehringer Ingelheim Investigational Site
  • 1100.1486.4926 Boehringer Ingelheim Investigational Site
  • 1100.1486.4901 Boehringer Ingelheim Investigational Site
  • 1100.1486.4930 Boehringer Ingelheim Investigational Site
  • 1100.1486.4909 Boehringer Ingelheim Investigational Site
  • 1100.1486.4920 Boehringer Ingelheim Investigational Site
  • 1100.1486.4925 Boehringer Ingelheim Investigational Site
  • 1100.1486.4915 Boehringer Ingelheim Investigational Site
  • 1100.1486.4923 Boehringer Ingelheim Investigational Site
  • 1100.1486.4910 Boehringer Ingelheim Investigational Site
  • 1100.1486.4907 Boehringer Ingelheim Investigational Site
  • 1100.1486.4924 Boehringer Ingelheim Investigational Site
  • 1100.1486.4927 Boehringer Ingelheim Investigational Site
  • 1100.1486.4903 Boehringer Ingelheim Investigational Site
  • 1100.1486.4904 Boehringer Ingelheim Investigational Site
  • 1100.1486.4912 Boehringer Ingelheim Investigational Site
  • 1100.1486.4905 Boehringer Ingelheim Investigational Site
  • 1100.1486.4918 Boehringer Ingelheim Investigational Site
  • 1100.1486.4913 Boehringer Ingelheim Investigational Site
  • 1100.1486.4914 Boehringer Ingelheim Investigational Site
  • 1100.1486.3531 Boehringer Ingelheim Investigational Site
  • 1100.1486.3532 Boehringer Ingelheim Investigational Site
  • 1100.1486.3908 Boehringer Ingelheim Investigational Site
  • 1100.1486.3905 Boehringer Ingelheim Investigational Site
  • 1100.1486.3901 Boehringer Ingelheim Investigational Site
  • 1100.1486.3907 Boehringer Ingelheim Investigational Site
  • 1100.1486.3906 Boehringer Ingelheim Investigational Site
  • 1100.1486.5207 Boehringer Ingelheim Investigational Site
  • 1100.1486.5204 Boehringer Ingelheim Investigational Site
  • 1100.1486.3107 Boehringer Ingelheim Investigational Site
  • 1100.1486.3103 Boehringer Ingelheim Investigational Site
  • 1100.1486.3101 Boehringer Ingelheim Investigational Site
  • 1100.1486.3102 Boehringer Ingelheim Investigational Site
  • 1100.1486.4803 Boehringer Ingelheim Investigational Site
  • 1100.1486.4801 Boehringer Ingelheim Investigational Site
  • 1100.1486.4804 Boehringer Ingelheim Investigational Site
  • 1100.1486.3503 Boehringer Ingelheim Investigational Site
  • 1100.1486.3501 Boehringer Ingelheim Investigational Site
  • 1100.1486.3504 Boehringer Ingelheim Investigational Site
  • 1100.1486.0024 Boehringer Ingelheim Investigational Site
  • 1100.1486.0033 Boehringer Ingelheim Investigational Site
  • 1100.1486.4001 Boehringer Ingelheim Investigational Site
  • 1100.1486.4002 Boehringer Ingelheim Investigational Site
  • 1100.1486.7002 Boehringer Ingelheim Investigational Site
  • 1100.1486.7001 Boehringer Ingelheim Investigational Site
  • 1100.1486.2707 Boehringer Ingelheim Investigational Site
  • 1100.1486.2712 Boehringer Ingelheim Investigational Site
  • 1100.1486.2703 Boehringer Ingelheim Investigational Site
  • 1100.1486.2709 Boehringer Ingelheim Investigational Site
  • 1100.1486.2711 Boehringer Ingelheim Investigational Site
  • 1100.1486.2701 Boehringer Ingelheim Investigational Site
  • 1100.1486.2710 Boehringer Ingelheim Investigational Site
  • 1100.1486.2706 Boehringer Ingelheim Investigational Site
  • 1100.1486.2702 Boehringer Ingelheim Investigational Site
  • 1100.1486.2704 Boehringer Ingelheim Investigational Site
  • 1100.1486.3406 Boehringer Ingelheim Investigational Site
  • 1100.1486.3401 Boehringer Ingelheim Investigational Site
  • 1100.1486.3402 Boehringer Ingelheim Investigational Site
  • 1100.1486.3410 Boehringer Ingelheim Investigational Site
  • 1100.1486.3415 Boehringer Ingelheim Investigational Site
  • 1100.1486.3417 Boehringer Ingelheim Investigational Site
  • 1100.1486.3404 Boehringer Ingelheim Investigational Site
  • 1100.1486.3403 Boehringer Ingelheim Investigational Site
  • 1100.1486.3405 Boehringer Ingelheim Investigational Site
  • 1100.1486.3407 Boehringer Ingelheim Investigational Site
  • 1100.1486.3414 Boehringer Ingelheim Investigational Site
  • 1100.1486.3416 Boehringer Ingelheim Investigational Site
  • 1100.1486.3408 Boehringer Ingelheim Investigational Site
  • 1100.1486.4101 Boehringer Ingelheim Investigational Site
  • 1100.1486.4109 Boehringer Ingelheim Investigational Site
  • 1100.1486.4107 Boehringer Ingelheim Investigational Site
  • 1100.1486.4106 Boehringer Ingelheim Investigational Site
  • 1100.1486.4104 Boehringer Ingelheim Investigational Site
  • 1100.1486.4102 Boehringer Ingelheim Investigational Site
  • 1100.1486.4108 Boehringer Ingelheim Investigational Site
  • 1100.1486.4110 Boehringer Ingelheim Investigational Site
  • 1100.1486.4406 Boehringer Ingelheim Investigational Site
  • 1100.1486.4403 Boehringer Ingelheim Investigational Site
  • 1100.1486.4404 Boehringer Ingelheim Investigational Site
  • 1100.1486.4405 Boehringer Ingelheim Investigational Site
  • 1100.1486.4407 Boehringer Ingelheim Investigational Site
  • 1100.1486.4401 Boehringer Ingelheim Investigational Site
  • 1100.1486.4408 Boehringer Ingelheim Investigational Site
  • 1100.1486.4402 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nevirapine XR

nevirapine IR

Arm Description

400 mg QD

200 mg BID

Outcomes

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
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
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
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
Occurrence of Rashes
Frequency of patients with drug related rash events by functional grouping
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
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.
Occurrence of Hepatic Events
Frequency of patients with hepatitis symptoms

Full Information

First Posted
November 20, 2007
Last Updated
March 7, 2014
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT00561925
Brief Title
VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1068 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nevirapine XR
Arm Type
Experimental
Arm Description
400 mg QD
Arm Title
nevirapine IR
Arm Type
Active Comparator
Arm Description
200 mg BID
Intervention Type
Drug
Intervention Name(s)
nevirapine IR
Intervention Description
200 mg BID
Intervention Type
Drug
Intervention Name(s)
nevirapine XR
Intervention Description
400 mg QD
Primary Outcome Measure Information:
Title
Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Description
Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL
Time Frame
week 48
Secondary Outcome Measure Information:
Title
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
Title
Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population
Description
Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL
Time Frame
week 144
Title
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
Title
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population
Time Frame
baseline, week 144
Title
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population
Time Frame
baseline, week 144
Title
Occurrence of Rashes
Description
Frequency of patients with drug related rash events by functional grouping
Time Frame
until last patient completed 144 weeks (up to 193 weeks)
Title
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade
Time Frame
until last patient completed 144 weeks (up to 193 weeks)
Title
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication
Time Frame
week 0 to 144
Title
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities
Time Frame
week 0 to 72
Title
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities
Time Frame
week 0 to 72
Title
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events
Time Frame
week 0 to 72
Title
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash
Time Frame
week 0 to 72
Title
Relative Bioavailability Trough C_pre,ss,1
Description
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.
Time Frame
week 132
Title
Occurrence of Hepatic Events
Description
Frequency of patients with hepatitis symptoms
Time Frame
until last patient completed 144 weeks (up to 193 weeks)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
21817198
Citation
Gathe J, Andrade-Villanueva J, Santiago S, Horban A, Nelson M, Cahn P, Bogner J, Spencer D, Podzamczer D, Yong CL, Nguyen T, Zhang W, Drulak M, Quinson AM. Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. Antivir Ther. 2011;16(5):759-69. doi: 10.3851/IMP1803.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1486_U12-3368-01_final.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1486_Literature.pdf
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs