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Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tenofovir DF 300 mg QD
tenofovir DF 300 mg QD
emtricitabine 200 mg QD
emtricitabine 200 mg QD
Nevirapine 200 mg BID
Atazanavir 300 mg
Ritonavir 100 mg
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 (GCP) and local regulatory requirements prior to trial participation
  2. HIV-1- infected males or females greater than or equal to 18 years of age with documented positive serology Enzyme-linked Immuno Sorbert Assay (ELISA) confirmed by Western blot
  3. No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND
  4. No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration
  5. Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed
  6. NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay
  7. Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula
  8. Karnofsky score greater than or equal to 70 (see Appendix 10.7)
  9. Acceptable medical history, as assessed by the investigator

Exclusion criteria:

  1. History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion)
  2. Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment

  3. Female patients of child-bearing potential who:

    have a positive serum pregnancy test 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

  4. Laboratory parameters greater than Division of Aids (National Institute of Health, USA) (DAIDS) grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1)
  5. Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C Virus (HCV) RNA positive with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ALT/AST greater than2.5x Upper Limit of Normal (ULN) (greater than DAIDS grade 1)
  6. Known hypersensitivity to any ingredients in nevirapine or atazanavir
  7. Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6
  8. Use of other investigational medications within 30 days before study entry or during the trial
  9. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone)
  10. Patients with Progressive Multifocal Leukoencephalopathy (PML), visceral Kaposi's Sarcoma (KS), and/or any lymphoma
  11. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at the screening visit
  12. Patients who are receiving systemic chemotherapy

Sites / Locations

  • 1100.1512.28 Boehringer Ingelheim Investigational Site
  • 1100.1512.20 Boehringer Ingelheim Investigational Site
  • 1100.1512.15 Boehringer Ingelheim Investigational Site
  • 1100.1512.26 Boehringer Ingelheim Investigational Site
  • 1100.1512.17 Boehringer Ingelheim Investigational Site
  • 1100.1512.14 Boehringer Ingelheim Investigational Site
  • 1100.1512.23 Boehringer Ingelheim Investigational Site
  • 1100.1512.29 Boehringer Ingelheim Investigational Site
  • 1100.1512.11 Boehringer Ingelheim Investigational Site
  • 1100.1512.25 Boehringer Ingelheim Investigational Site
  • 1100.1512.18 Boehringer Ingelheim Investigational Site
  • 1100.1512.22 Boehringer Ingelheim Investigational Site
  • 1100.1512.21 Boehringer Ingelheim Investigational Site
  • 1100.1512.13 Boehringer Ingelheim Investigational Site
  • 1100.1512.30 Boehringer Ingelheim Investigational Site
  • 1100.1512.19 Boehringer Ingelheim Investigational Site
  • 1100.1512.16 Boehringer Ingelheim Investigational Site
  • 1100.1512.24 Boehringer Ingelheim Investigational Site
  • 1100.1512.27 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

NVP 200mg bis indie (BID)

Atazanavir 300 mg QD/ritonavir 100 mg QD

Arm Description

after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks

patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks

Outcomes

Primary Outcome Measures

Number of Participants With Virologic Response (VR)
VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.

Secondary Outcome Measures

Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.
Number of Participants With Virologic Success (FDA Definition)
HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Time to response whereby patients withdrawing early were censored after their withdrawal
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment
Number of Patients With Virologic Rebound to >400 Copies/ml
HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting. Number of cases (no time-to analysis was performed due to small numbers).
Change in CD4+ Cell Count From Baseline to Week 2.
Patients on-treatment, data within time windows
Change in CD4+ Cell Count From Baseline to Week 4.
Patients on-treatment, data within time windows
Change in CD4+ Cell Count From Baseline to Week 6.
Patients on-treatment, data within time windows
Change in CD4+ Cell Count From Baseline to Week 8.
Patients on-treatment, data within time windows
Change in CD4+ Cell Count From Baseline to Week 12.
Patients on-treatment, data within time windows
Change in CD4+ Cell Count From Baseline to Week 24.
Patients on-treatment, data within time windows
Change in CD4+ Cell Count From Baseline to Week 36.
Patients on-treatment, data within time windows
Change in CD4+ Cell Count From Baseline to Week 48.
Patients on-treatment, data within time windows
Change in Fasting Plasma Total Cholesterol Level
Change in Fasting Plasma Triglycerides Level
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Change in Framingham Score
Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.
Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Percentage Adherence by Pill Count
Number of pills not returned / number of treatment days in percent (%)
Number of Participants With Genotypic Resistance at the Time of Virologic Failure.
Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.
Incidence of Patients With AIDS Progression at Each Visit
Cumulative incidence of patients with AIDS progression are shown
Proportion of Patients Reporting CNS Side Effects of Any Severity
Proportion of Patients Reporting Hepatic Events of Any Severity
Proportion of Patients Reporting Rash of Any Severity
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities

Full Information

First Posted
September 28, 2007
Last Updated
December 9, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00552240
Brief Title
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
Official Title
Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).

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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVP 200mg bis indie (BID)
Arm Type
Active Comparator
Arm Description
after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
Arm Title
Atazanavir 300 mg QD/ritonavir 100 mg QD
Arm Type
Active Comparator
Arm Description
patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks
Intervention Type
Drug
Intervention Name(s)
tenofovir DF 300 mg QD
Intervention Description
300 mg QD
Intervention Type
Drug
Intervention Name(s)
tenofovir DF 300 mg QD
Intervention Description
300 mg QD
Intervention Type
Drug
Intervention Name(s)
emtricitabine 200 mg QD
Intervention Description
200 mg QD
Intervention Type
Drug
Intervention Name(s)
emtricitabine 200 mg QD
Intervention Description
200 mg QD
Intervention Type
Drug
Intervention Name(s)
Nevirapine 200 mg BID
Intervention Description
200 mg BID
Intervention Type
Drug
Intervention Name(s)
Atazanavir 300 mg
Intervention Description
300 mg QD
Intervention Type
Drug
Intervention Name(s)
Ritonavir 100 mg
Intervention Description
100 mg QD
Primary Outcome Measure Information:
Title
Number of Participants With Virologic Response (VR)
Description
VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
Time Frame
baseline to week 48
Secondary Outcome Measure Information:
Title
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Description
HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.
Time Frame
baseline to week 48
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Description
HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.
Time Frame
baseline to week 48
Title
Number of Participants With Virologic Success (FDA Definition)
Description
HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).
Time Frame
baseline to week 48
Title
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Description
Time to response whereby patients withdrawing early were censored after their withdrawal
Time Frame
baseline to week 48
Title
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Time Frame
baseline to week 48
Title
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
Description
HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Time Frame
baseline to week 24 and week 48
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 2
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 4
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 6
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 8
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 12
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 24
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 36
Title
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 48
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 2
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 4
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 6
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 8
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 12
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 24
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 36
Title
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Description
Results within time windows, patients on-treatment
Time Frame
baseline to week 48
Title
Number of Patients With Virologic Rebound to >400 Copies/ml
Description
HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Time Frame
baseline to week 48
Title
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
Description
AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting. Number of cases (no time-to analysis was performed due to small numbers).
Time Frame
baseline to week 48
Title
Change in CD4+ Cell Count From Baseline to Week 2.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 2
Title
Change in CD4+ Cell Count From Baseline to Week 4.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 4
Title
Change in CD4+ Cell Count From Baseline to Week 6.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 6
Title
Change in CD4+ Cell Count From Baseline to Week 8.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 8
Title
Change in CD4+ Cell Count From Baseline to Week 12.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 12
Title
Change in CD4+ Cell Count From Baseline to Week 24.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 24
Title
Change in CD4+ Cell Count From Baseline to Week 36.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 36
Title
Change in CD4+ Cell Count From Baseline to Week 48.
Description
Patients on-treatment, data within time windows
Time Frame
baseline to week 48
Title
Change in Fasting Plasma Total Cholesterol Level
Time Frame
baseline to week 48
Title
Change in Fasting Plasma Triglycerides Level
Time Frame
baseline to week 48
Title
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Time Frame
baseline to week 48
Title
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Time Frame
baseline to week 48
Title
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Time Frame
baseline to week 48
Title
Change in Framingham Score
Description
Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.
Time Frame
baseline to week 48
Title
Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Time Frame
baseline to week 48
Title
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
Description
using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time Frame
baseline to week 48
Title
Percentage Adherence by Pill Count
Description
Number of pills not returned / number of treatment days in percent (%)
Time Frame
baseline to week 48
Title
Number of Participants With Genotypic Resistance at the Time of Virologic Failure.
Description
Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.
Time Frame
baseline to week 48
Title
Incidence of Patients With AIDS Progression at Each Visit
Description
Cumulative incidence of patients with AIDS progression are shown
Time Frame
baseline to week 52
Title
Proportion of Patients Reporting CNS Side Effects of Any Severity
Time Frame
baseline to week 52
Title
Proportion of Patients Reporting Hepatic Events of Any Severity
Time Frame
baseline to week 52
Title
Proportion of Patients Reporting Rash of Any Severity
Time Frame
baseline to week 52
Title
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Time Frame
baseline to week 52

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 (GCP) and local regulatory requirements prior to trial participation HIV-1- infected males or females greater than or equal to 18 years of age with documented positive serology Enzyme-linked Immuno Sorbert Assay (ELISA) confirmed by Western blot No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula Karnofsky score greater than or equal to 70 (see Appendix 10.7) Acceptable medical history, as assessed by the investigator Exclusion criteria: History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion) Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment Female patients of child-bearing potential who: have a positive serum pregnancy test 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 Laboratory parameters greater than Division of Aids (National Institute of Health, USA) (DAIDS) grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1) Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C Virus (HCV) RNA positive with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ALT/AST greater than2.5x Upper Limit of Normal (ULN) (greater than DAIDS grade 1) Known hypersensitivity to any ingredients in nevirapine or atazanavir Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6 Use of other investigational medications 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, chronic treatment with prednisone) Patients 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 the screening visit Patients who are receiving systemic chemotherapy
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
1100.1512.28 Boehringer Ingelheim Investigational Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
1100.1512.20 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1100.1512.15 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1100.1512.26 Boehringer Ingelheim Investigational Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
1100.1512.17 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1100.1512.14 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
1100.1512.23 Boehringer Ingelheim Investigational Site
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
1100.1512.29 Boehringer Ingelheim Investigational Site
City
Maywood
State/Province
Illinois
Country
United States
Facility Name
1100.1512.11 Boehringer Ingelheim Investigational Site
City
Neptune
State/Province
New Jersey
Country
United States
Facility Name
1100.1512.25 Boehringer Ingelheim Investigational Site
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
1100.1512.18 Boehringer Ingelheim Investigational Site
City
Somers Point
State/Province
New Jersey
Country
United States
Facility Name
1100.1512.22 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1100.1512.21 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1100.1512.13 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1100.1512.30 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1100.1512.19 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
1100.1512.16 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1100.1512.24 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1100.1512.27 Boehringer Ingelheim Investigational Site
City
Annandale
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1512_U10-3622.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1512_literature.pdf
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Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

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