Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
NCT ID: NCT00552240
Last Updated: 2014-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
154 participants
INTERVENTIONAL
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NVP 200mg bis indie (BID)
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
tenofovir DF 300 mg QD
300 mg QD
emtricitabine 200 mg QD
200 mg QD
Nevirapine 200 mg BID
200 mg BID
Atazanavir 300 mg QD/ritonavir 100 mg QD
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
tenofovir DF 300 mg QD
300 mg QD
emtricitabine 200 mg QD
200 mg QD
Atazanavir 300 mg
300 mg QD
Ritonavir 100 mg
100 mg QD
Interventions
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tenofovir DF 300 mg QD
300 mg QD
tenofovir DF 300 mg QD
300 mg QD
emtricitabine 200 mg QD
200 mg QD
emtricitabine 200 mg QD
200 mg QD
Nevirapine 200 mg BID
200 mg BID
Atazanavir 300 mg
300 mg QD
Ritonavir 100 mg
100 mg QD
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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 D.C., 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 City, 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
Countries
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Other Identifiers
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1100.1512
Identifier Type: -
Identifier Source: org_study_id
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