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

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ClinicalTrials.gov Identifier: NCT00552240
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : May 23, 2011
Last Update Posted : January 27, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: tenofovir DF 300 mg QD Drug: emtricitabine 200 mg QD Drug: Nevirapine 200 mg BID Drug: Atazanavir 300 mg Drug: Ritonavir 100 mg Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
Study Start Date : September 2007
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: tenofovir DF 300 mg QD
300 mg QD
Drug: emtricitabine 200 mg QD
200 mg QD
Drug: Nevirapine 200 mg BID
200 mg BID
Active Comparator: 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
 Drug: tenofovir DF 300 mg QD
300 mg QD
Drug: emtricitabine 200 mg QD
200 mg QD
Drug: Atazanavir 300 mg
300 mg QD
Drug: Ritonavir 100 mg
100 mg QD


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Virologic Response (VR) [ Time Frame: baseline to week 48 ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: baseline to week 48 ]
    HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.

  2. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 [ Time Frame: baseline to week 48 ]
    HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.

  3. Number of Participants With Virologic Success (FDA Definition) [ Time Frame: baseline to week 48 ]
    HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).

  4. Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants [ Time Frame: baseline to week 48 ]
    Time to response whereby patients withdrawing early were censored after their withdrawal

  5. Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml [ Time Frame: baseline to week 48 ]
  6. Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response [ Time Frame: baseline to week 24 and week 48 ]
    HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)

  7. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment [ Time Frame: baseline to week 2 ]
    Results within time windows, patients on-treatment

  8. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment [ Time Frame: baseline to week 4 ]
    Results within time windows, patients on-treatment

  9. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment [ Time Frame: baseline to week 6 ]
    Results within time windows, patients on-treatment

  10. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment [ Time Frame: baseline to week 8 ]
    Results within time windows, patients on-treatment

  11. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment [ Time Frame: baseline to week 12 ]
    Results within time windows, patients on-treatment

  12. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment [ Time Frame: baseline to week 24 ]
    Results within time windows, patients on-treatment

  13. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment [ Time Frame: baseline to week 36 ]
    Results within time windows, patients on-treatment

  14. Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment [ Time Frame: baseline to week 48 ]
    Results within time windows, patients on-treatment

  15. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment [ Time Frame: baseline to week 2 ]
    Results within time windows, patients on-treatment

  16. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment [ Time Frame: baseline to week 4 ]
    Results within time windows, patients on-treatment

  17. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment [ Time Frame: baseline to week 6 ]
    Results within time windows, patients on-treatment

  18. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment [ Time Frame: baseline to week 8 ]
    Results within time windows, patients on-treatment

  19. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment [ Time Frame: baseline to week 12 ]
    Results within time windows, patients on-treatment

  20. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment [ Time Frame: baseline to week 24 ]
    Results within time windows, patients on-treatment

  21. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment [ Time Frame: baseline to week 36 ]
    Results within time windows, patients on-treatment

  22. Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment [ Time Frame: baseline to week 48 ]
    Results within time windows, patients on-treatment

  23. Number of Patients With Virologic Rebound to >400 Copies/ml [ Time Frame: baseline to week 48 ]
    HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)

  24. AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death [ Time Frame: baseline to week 48 ]

    AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.

    Number of cases (no time-to analysis was performed due to small numbers).


  25. Change in CD4+ Cell Count From Baseline to Week 2. [ Time Frame: baseline to week 2 ]
    Patients on-treatment, data within time windows

  26. Change in CD4+ Cell Count From Baseline to Week 4. [ Time Frame: baseline to week 4 ]
    Patients on-treatment, data within time windows

  27. Change in CD4+ Cell Count From Baseline to Week 6. [ Time Frame: baseline to week 6 ]
    Patients on-treatment, data within time windows

  28. Change in CD4+ Cell Count From Baseline to Week 8. [ Time Frame: baseline to week 8 ]
    Patients on-treatment, data within time windows

  29. Change in CD4+ Cell Count From Baseline to Week 12. [ Time Frame: baseline to week 12 ]
    Patients on-treatment, data within time windows

  30. Change in CD4+ Cell Count From Baseline to Week 24. [ Time Frame: baseline to week 24 ]
    Patients on-treatment, data within time windows

  31. Change in CD4+ Cell Count From Baseline to Week 36. [ Time Frame: baseline to week 36 ]
    Patients on-treatment, data within time windows

  32. Change in CD4+ Cell Count From Baseline to Week 48. [ Time Frame: baseline to week 48 ]
    Patients on-treatment, data within time windows

  33. Change in Fasting Plasma Total Cholesterol Level [ Time Frame: baseline to week 48 ]
  34. Change in Fasting Plasma Triglycerides Level [ Time Frame: baseline to week 48 ]
  35. Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level [ Time Frame: baseline to week 48 ]
  36. Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level [ Time Frame: baseline to week 48 ]
  37. Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio [ Time Frame: baseline to week 48 ]
  38. Change in Framingham Score [ Time Frame: baseline to week 48 ]
    Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.

  39. Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group [ Time Frame: baseline to week 48 ]
  40. Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48 [ Time Frame: baseline to week 48 ]
    using 4-variable Modification of Diet in Renal Disease (MDRD) formula

  41. Percentage Adherence by Pill Count [ Time Frame: baseline to week 48 ]
    Number of pills not returned / number of treatment days in percent (%)

  42. Number of Participants With Genotypic Resistance at the Time of Virologic Failure. [ Time Frame: baseline to week 48 ]
    Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.

  43. Incidence of Patients With AIDS Progression at Each Visit [ Time Frame: baseline to week 52 ]
    Cumulative incidence of patients with AIDS progression are shown

  44. Proportion of Patients Reporting CNS Side Effects of Any Severity [ Time Frame: baseline to week 52 ]
  45. Proportion of Patients Reporting Hepatic Events of Any Severity [ Time Frame: baseline to week 52 ]
  46. Proportion of Patients Reporting Rash of Any Severity [ Time Frame: baseline to week 52 ]
  47. Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities [ Time Frame: baseline to week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552240


Locations
United States, California
1100.1512.28 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1100.1512.20 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
United States, Colorado
1100.1512.15 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, District of Columbia
1100.1512.26 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
United States, Florida
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
United States, Illinois
1100.1512.29 Boehringer Ingelheim Investigational Site
Maywood, Illinois, United States
United States, New Jersey
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
United States, North Carolina
1100.1512.22 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, Pennsylvania
1100.1512.21 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
1100.1512.13 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
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
United States, Virginia
1100.1512.27 Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00552240     History of Changes
Other Study ID Numbers: 1100.1512
First Posted: November 1, 2007    Key Record Dates
Results First Posted: May 23, 2011
Last Update Posted: January 27, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Atazanavir Sulfate
Tenofovir
Emtricitabine
 Nevirapine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP3A Inducers