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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: tenofovir DF 300 mg QD (Drug); tenofovir DF 300 mg QD (Drug); emtricitabine 200 mg QD (Drug); emtricitabine 200 mg QD (Drug); Nevirapine 200 mg BID (Drug); Atazanavir 300 mg (Drug); Ritonavir 100 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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).

Clinical Details

Official title: Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Virologic Response (VR)

Secondary outcome:

Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48

Number of Participants With Virologic Success (FDA Definition)

Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants

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

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment

Number of Patients With Virologic Rebound to >400 Copies/ml

AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death

Change in CD4+ Cell Count From Baseline to Week 2.

Change in CD4+ Cell Count From Baseline to Week 4.

Change in CD4+ Cell Count From Baseline to Week 6.

Change in CD4+ Cell Count From Baseline to Week 8.

Change in CD4+ Cell Count From Baseline to Week 12.

Change in CD4+ Cell Count From Baseline to Week 24.

Change in CD4+ Cell Count From Baseline to Week 36.

Change in CD4+ Cell Count From Baseline to Week 48.

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

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

Percentage Adherence by Pill Count

Number of Participants With Genotypic Resistance at the Time of Virologic Failure.

Incidence of Patients With AIDS Progression at Each Visit

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

1100.1512.28 Boehringer Ingelheim Investigational Site, Beverly Hills, California, United States

1100.1512.20 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States

1100.1512.15 Boehringer Ingelheim Investigational Site, Denver, Colorado, United States

1100.1512.26 Boehringer Ingelheim Investigational Site, Washington, District of Columbia, United States

1100.1512.17 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States

1100.1512.14 Boehringer Ingelheim Investigational Site, Orlando, Florida, United States

1100.1512.23 Boehringer Ingelheim Investigational Site, Vero Beach, Florida, United States

1100.1512.29 Boehringer Ingelheim Investigational Site, Maywood, Illinois, United States

1100.1512.11 Boehringer Ingelheim Investigational Site, Neptune, New Jersey, United States

1100.1512.25 Boehringer Ingelheim Investigational Site, Newark, New Jersey, United States

1100.1512.18 Boehringer Ingelheim Investigational Site, Somers Point, New Jersey, United States

1100.1512.22 Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States

1100.1512.21 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

1100.1512.13 Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States

1100.1512.30 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States

1100.1512.19 Boehringer Ingelheim Investigational Site, Fort Worth, Texas, United States

1100.1512.16 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1100.1512.24 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1100.1512.27 Boehringer Ingelheim Investigational Site, Annandale, Virginia, United States

Additional Information

Starting date: September 2007
Last updated: December 9, 2013

Page last updated: August 23, 2015

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