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

NCT00552240 | Completed Phase 4 Results

• 1 other identifier: 1100.1512
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 19

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).

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to week 48

Secondary Outcomes (47)

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

  baseline to week 48

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

  baseline to week 48

• Number of Participants With Virologic Success (FDA Definition)

  baseline to week 48

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

  baseline to week 48

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

  baseline to week 48

Study Arms (2)

NVP 200mg bis indie (BID)

ACTIVE COMPARATOR

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

Drug: tenofovir DF 300 mg QD; Drug: emtricitabine 200 mg QD; Drug: Nevirapine 200 mg BID

Atazanavir 300 mg QD/ritonavir 100 mg QD

ACTIVE COMPARATOR

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

Drug: tenofovir DF 300 mg QD; Drug: emtricitabine 200 mg QD; Drug: Atazanavir 300 mg; Drug: Ritonavir 100 mg

Interventions

tenofovir DF 300 mg QD DRUG

300 mg QD

Atazanavir 300 mg QD/ritonavir 100 mg QD

emtricitabine 200 mg QD DRUG

200 mg QD

Atazanavir 300 mg QD/ritonavir 100 mg QD

Nevirapine 200 mg BID DRUG

200 mg BID

NVP 200mg bis indie (BID)

Atazanavir 300 mg DRUG

300 mg QD

Atazanavir 300 mg QD/ritonavir 100 mg QD

Ritonavir 100 mg DRUG

100 mg QD

Atazanavir 300 mg QD/ritonavir 100 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (19)

1100.1512.28 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1100.1512.20 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1100.1512.15 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1100.1512.26 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Location

1100.1512.17 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1100.1512.14 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1100.1512.23 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Location

1100.1512.29 Boehringer Ingelheim Investigational Site

Maywood, Illinois, United States

Location

1100.1512.11 Boehringer Ingelheim Investigational Site

Neptune City, New Jersey, United States

Location

1100.1512.25 Boehringer Ingelheim Investigational Site

Newark, New Jersey, United States

Location

1100.1512.18 Boehringer Ingelheim Investigational Site

Somers Point, New Jersey, United States

Location

1100.1512.22 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1100.1512.21 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1100.1512.13 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1100.1512.30 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1100.1512.19 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

1100.1512.16 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1100.1512.24 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1100.1512.27 Boehringer Ingelheim Investigational Site

Annandale, Virginia, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Nevirapine; BID protein, human; Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Azoles

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: November 1, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2010
• Last Updated: January 27, 2014
• Results First Posted: May 23, 2011

Record last verified: 2013-12

Locations

US (19)