Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in HIV Infected Naive Patients (NEwArT) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 28, 2007

Last Updated Date

November 23, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is the virologic response (VR) at Week 48. VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits by Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. [ Time Frame: 48 weeks ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00552240 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to virologic response defined as the first of the two consecutive measurements showing VL <50 copies/ml. Proportions of patients with an HIV viral load of <50 and <400 copies/ml at each visit [ Time Frame: 48 weeks ]

Original Secondary Outcome Measures ^ICMJE

Time to virologic response defined as the first of the two consecutive measurements showing VL <50 copies/ml. Proportions of patients with an HIV viral load of <50 and <400 copies/ml at each visit

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Comparison ATV/r vs NVP Bid on Truvada Backbone

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Nevirapine
Drug: Atazanavir/ritonavir
Drug: Emtricitabine (FTC) and Tenofovir (TDF)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

155

Completion Date

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Signed informed consent in accordance with 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 (ELISA) confirmed by Western blot
No prior NRTI or NNRTI use of more than 10 days AND
No prior use of other classes of 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 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 HCV RNA positive with ALT/AST greater than2.5x 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00552240

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

1100.1512

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP