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OpenTrials
Completed

NCT Number: NCT00552240

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1100.1512.28 Boehringer Ingelheim Investigational Site, Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 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

Treatment and study plan

tenofovir DF 300 mg QD

Drug

300 mg QD

emtricitabine 200 mg QD

Drug

200 mg QD

Nevirapine 200 mg BID

Drug

200 mg BID

Atazanavir 300 mg

Drug

300 mg QD

Ritonavir 100 mg

Drug

100 mg QD

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone

Important dates

Study start
2007
Primary completion
2010
First posted
Nov 1, 2007
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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