Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
- NCT00552240
- PHASE4
- INTERVENTIONAL
Last updated: 2014-01-27
Purpose of Trial
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).
This study is for people with
HIV Infections
Interventions being studied
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
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
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
19 Locations
Beverly Hills
1100.1512.28 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1100.1512.20 Boehringer Ingelheim Investigational Site
California, United States
Denver
1100.1512.15 Boehringer Ingelheim Investigational Site
Colorado, United States
Washington
1100.1512.26 Boehringer Ingelheim Investigational Site
District of Columbia, United States
Fort Lauderdale
1100.1512.17 Boehringer Ingelheim Investigational Site
Florida, United States
Orlando
1100.1512.14 Boehringer Ingelheim Investigational Site
Florida, United States
Vero Beach
1100.1512.23 Boehringer Ingelheim Investigational Site
Florida, United States
Maywood
1100.1512.29 Boehringer Ingelheim Investigational Site
Illinois, United States
Neptune
1100.1512.11 Boehringer Ingelheim Investigational Site
New Jersey, United States
Newark
1100.1512.25 Boehringer Ingelheim Investigational Site
New Jersey, United States
Somers Point
1100.1512.18 Boehringer Ingelheim Investigational Site
New Jersey, United States
Winston-Salem
1100.1512.22 Boehringer Ingelheim Investigational Site
North Carolina, United States
Philadelphia
1100.1512.21 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Charleston
1100.1512.13 Boehringer Ingelheim Investigational Site
South Carolina, United States
Dallas
1100.1512.30 Boehringer Ingelheim Investigational Site
Texas, United States
Fort Worth
1100.1512.19 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1100.1512.16 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1100.1512.24 Boehringer Ingelheim Investigational Site
Texas, United States
Annandale
1100.1512.27 Boehringer Ingelheim Investigational Site
Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov