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CompletedNCT00389207Updated Jan 27, 2014Results posted

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

A Phase 3 interventional study of nevirapine bid and nevirapine qd in HIV Infections, sponsored by Boehringer Ingelheim. Completed at 68 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-27.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
576
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil fumarate (DF) (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg twice daily, or NVP 400 mg once daily , or ritonavir-boosted atazanavir (ATZ/r), all in combination with emtricitabine (FTC) and tenofovir DF (TDF).

All patients receiving NVP will start at 200 mg once daily for 2 weeks, because it has been demonstrated that this lead-in dosing regimen reduces the frequency of NVP-induced rash. At Visit 3 (Week 2), patients increase the NVP dose to either 200 mg twice daily or to 400 mg once daily. Patients receiving ATZ/r will be treated with ATZ 300 mg once daily, boosted by 100 mg ritonavir (RTV) once daily. Background antiretroviral therapy for all patients consists of one tablet of Truvada. Treatment duration is 48 weeks (primary endpoint) with an extension to 144 weeks. Patients may also participate in the metabolic sub-study, comparing NVP and ATZ/r for signs and symptoms of lipodystrophy and serum lipid/glycaemic abnormalities.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 576 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion 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 >= 18 years of age with positive serology confirmed by Western blot
  3. No previous antiretroviral treatment (of more than 7 days)
  4. Males with CD4+ counts of \< 400 cells/mm3 and females with CD4+ counts of \< 250 cells/mm3
  5. NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report
  6. Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 ml/min according to the Cockcroft-Gault formula
  7. Karnofsky score >= 70
  8. Acceptable medical history, as assessed by the investigator

Exclusion criteria:

Exclusion Criteria:

  1. Active drug abuse or chronic alcoholism at the investigator's discretion
  2. Hepatic cirrhosis stage Child-Pugh B or C

  3. Female patients of child-bearing potential who:

    • have a positive serum pregnancy test at screening or during the study,
    • 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 Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions)
  5. Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-Ribo Nucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) > 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1)
  6. Hypersensitivity to any ingredients of the test products
  7. Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study
  8. Patients who are receiving other concomitant treatments which are not permitted
  9. Use of other investigational medications within 30 days before study entry or during the trial
  10. 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)
  11. Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
  12. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
  13. Patients who are receiving systemic treatment for malignant disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
576 participants (actual)

Study arms

  • Active comparator
    NVP bid

    nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF)

    Drug: nevirapine bid

  • Experimental
    NVP qd

    nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF)

    Drug: nevirapine qd

  • Active comparator
    ATZ/r

    ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF)

    Drug: atazanavir

Interventions

  • Drugnevirapine bid

    nevirapine twice daily

  • Drugnevirapine qd

    nevirapine once daily

  • Drugatazanavir

    atazanavir once daily

06

What researchers measure

Primary outcomes

  1. Treatment Response at Week 48

    Treatment response is defined as a viral load (VL) \<50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.

    Time frame: From baseline to Week 48

Secondary outcomes

  1. Treatment Response at Week 48 (TLOVR Algorithm)

    Treatment response is defined as a VL \<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, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.

    Time frame: From baseline to Week 48

  2. Proportion of Patients With VL < 50 Copies/ml

    VL \<50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient

    Time frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

  3. Proportion of Patients With VL < 400 Copies/ml

    VL \<400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)

    Time frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

  4. Change in CD4+ Count From Baseline

    Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT

    Time frame: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

  5. Change in Framingham Score From Baseline

    Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.

    Time frame: From baseline to Weeks 48, 96 and 144/EOT

  6. Change in Mental Health Summary (MHS) Score From Baseline

    Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

    Time frame: From baseline to Weeks 48, 96 and 144/EOT

  7. Change in Physical Health Summary (PHS) Score From Baseline

    QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

    Time frame: From baseline to Weeks 48, 96 and 144/EOT

  8. Number of Patients Hospitalized

    Cost effectiveness assessment by number of patients hospitalized

    Time frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT

  9. Non-scheduled Physician Visits

    Cost effectiveness assessment by number of patients with non-scheduled physician visits

    Time frame: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT

  10. Genotypic Resistance Associated With Virologic Failure

    Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.

    Time frame: From baseline to Week 48

  11. Treatment-emergent AIDS-defining Illness

    Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment

    Time frame: From baseline to Week 144

  12. Treatment-emergent AIDS-defining Illness Leading to Death

    Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.

    Time frame: From baseline to Week 144

  13. Lipodystrophy

    Number of patients with AE lipodystrophy

    Time frame: From baseline to Week 144

  14. Serum Lipid Abnormalities

    Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)

    Time frame: From baseline to Week 144

  15. Glycaemic Abnormalities

    Number of patients with AE elevated serum glucose

    Time frame: From baseline to Week 144

  16. Treatment Response at Week 96

    Treatment response is defined as a viral load (VL) \<50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.

    Time frame: From baseline to Week 96

  17. Treatment Response at Week 144

    Treatment response is defined as a viral load (VL) \<50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.

    Time frame: From baseline to Week 144

  18. Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144

    The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

    Time frame: at Week 24, 48, 96, 144

  19. Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144

    The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

    Time frame: at Week 24, 48, 96, 144

  20. Proportion of Patients With Virologic Failure at Week 48, 96, 144

    Time frame: at Week 48, 96, 144

  21. Time to Treatment Response (First Confirmed VL<50 Copies/mL)

    Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response

    Time frame: baseline to week 144

  22. Time to Loss of Virologic Response (Rebound)

    Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.

    Time frame: Baseline to week 144

  23. Time to Treatment Failure

    Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count \< 50 copies/mL up to Visit 10 (week 48) or loss of virologic response

    Time frame: baseline to week 144

  24. Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144

    Calculations based on the MDRD algorithm.

    Time frame: From baseline to Week 48, 96, 144

  25. Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities

    Time frame: week 148

  26. Proportion of Patients Reporting Rash of Any Severity

    Proportion of Patients reporting rash of any severity

    Time frame: week 148

  27. Proportion of Patients Reporting Hepatic Events of Any Severity

    Proportion of Patients reporting hepatic events of any severity

    Time frame: week 148

  28. Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity

    Proportion of Patients reporting CNS (central nervous system) side effects of any severity

    Time frame: week 148

  29. Change of Cholesterol Values From Baseline to Week 48, 96, 144

    Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL

    Time frame: baseline to week 48, 96, 144

  30. Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144

    Changes frombaseline apolipoprotein A1 \& B

    Time frame: baseline to week 48, 96, 144

  31. Change of hsCRP From Baseline to Week 48, 96, 144

    Change of hsCRP from baseline to week 48, 96, 144

    Time frame: baseline to week 48, 96, 144

  32. Change of Total Triglycerides From Baseline to Week 48, 96, 144

    Change of total triglycerides from baseline to week 48, 96, 144

    Time frame: baseline to week 48, 96, 144

  33. Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144

    Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144

    Time frame: baseline to week 48, 96, 144

07

Results

Posted Mar 26, 2012

Participant flow

Participant flow — Overall Study
MilestoneNevirapine QDNevirapine BIDAtazanvir/Ritonavir
Started188188193
Completed125116152
Not completed637241
Withdrew: Adverse event263210
Withdrew: Protocol violation314
Withdrew: Lost to follow-up1297
Withdrew: Withdrawal by subject5711
Withdrew: Other17239

Outcome measures

PrimaryTreatment Response at Week 48

Treatment response is defined as a viral load (VL) \<50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.

Time frame:
From baseline to Week 48
Reported as:
Number · Patients
Treatment Response at Week 48
PatientsNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
Number of responders126124250126
Number of non-responders626412667
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.684 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): 0.016 · 95% CI -0.062 to 0.095Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)
  • Nevirapine QD vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.584 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): 0.025 · 95% CI -0.065 to 0.115Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
  • Nevirapine BID vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.855 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): 0.009 · 95% CI -0.084 to 0.101Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
SecondaryTreatment Response at Week 48 (TLOVR Algorithm)

Treatment response is defined as a VL \<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, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.

Time frame:
From baseline to Week 48
Reported as:
Number · Patients
Treatment Response at Week 48 (TLOVR Algorithm)
PatientsNevirapine QD+BIDAtazanvir/Ritonavir
Number of responders261142
Number of non-responders11551
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.321 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): -0.038 · 95% CI -0.112 to 0.037Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.
SecondaryProportion of Patients With VL < 50 Copies/ml

VL \<50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient

Time frame:
From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
Reported as:
Number · Proportion of patients
Proportion of Patients With VL < 50 Copies/ml
Proportion of patientsNevirapine QD+BIDAtazanvir/Ritonavir
Proportion with VL<50 copies /mL at Week 40.1070.09
Proportion with VL<50 copies /mL at Week 80.3040.25
Proportion with VL<50 copies /mL at Week 120.5150.412
Proportion with VL<50 copies /mL at Week 240.8420.779
Proportion with VL<50 copies /mL at Week 360.9070.83
Proportion with VL<50 copies /mL at Week 480.9310.886
Proportion with VL<50 copies /mL at Week 600.9590.901
Proportion with VL<50 copies /mL at Week 720.9650.915
Proportion with VL<50 copies /mL at Week 840.9720.896
Proportion with VL<50 copies /mL at Week 960.980.924
Proportion with VL<50 copies /mL at Week 1080.9640.968
Proportion with VL<50 copies /mL at Week 1200.9760.955
Proportion with VL<50 copies /mL at Week 1320.9710.947
Proportion with VL<50 copies /mL at Week 144/EOT0.9520.929
SecondaryProportion of Patients With VL < 400 Copies/ml

VL \<400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)

Time frame:
From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
Reported as:
Number · Proportion of patients
Proportion of Patients With VL < 400 Copies/ml
Proportion of patientsNevirapine QD+BIDAtazanvir/Ritonavir
Proportion with VL<400 copies /mL at Week 40.3650.287
Proportion with VL<400 copies /mL at Week 80.7140.679
Proportion with VL<400 copies /mL at Week 120.8560.834
Proportion with VL<400 copies /mL at Week 240.9240.956
Proportion with VL<400 copies /mL at Week 360.9680.966
Proportion with VL<400 copies /mL at Week 480.9850.977
Proportion with VL<400 copies /mL at Week 600.9930.988
Proportion with VL<400 copies /mL at Week 720.9960.988
Proportion with VL<400 copies /mL at Week 840.9880.994
Proportion with VL<400 copies /mL at Week 961.0000.987
Proportion with VL<400 copies /mL at Week 1080.9961.000
Proportion with VL<400 copies /mL at Week 1201.0000.994
Proportion with VL<400 copies /mL at Week 1320.9960.993
Proportion with VL<400 copies /mL at Week 144/EOT0.9910.986
SecondaryChange in CD4+ Count From Baseline

Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT

Time frame:
From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
Reported as:
Mean · cells/mm^3
Change in CD4+ Count From Baseline
cells/mm^3Nevirapine QD+BIDAtazanvir/Ritonavir
Change in CD4+ count to Week 477.2 ± 93.586.1 ± 94.4
Change in CD4+ count to Week 8105.6 ± 108.098.0 ± 91.1
Change in CD4+ count to Week 12120.3 ± 113.9110.9 ± 111.6
Change in CD4+ count to Week 24134.4 ± 114.9133.8 ± 110.7
Change in CD4+ count to Week 36160.1 ± 123.0163.4 ± 119.8
Change in CD4+ count to Week 48168.2 ± 127.0183.6 ± 121.6
Change in CD4+ count to Week 60184.8 ± 129.6208.2 ± 144.2
Change in CD4+ count to Week 72213.7 ± 165.7231.9 ± 165.4
Change in CD4+ count to Week 84223.0 ± 147.1246.4 ± 149.4
Change in CD4+ count to Week 96217.7 ± 133.5251.6 ± 149.8
Change in CD4+ count to Week 108231.2 ± 148.9267.2 ± 161.2
Change in CD4+ count to Week 120231.3 ± 147.6269.2 ± 169.9
Change in CD4+ count to Week 132243.4 ± 164.8281.3 ± 147.3
Change in CD4+ count to Week 144/EOT251.0 ± 151.6285.8 ± 164.8
SecondaryChange in Framingham Score From Baseline

Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.

Time frame:
From baseline to Weeks 48, 96 and 144/EOT
Reported as:
Mean · Units on a scale
Change in Framingham Score From Baseline
Units on a scaleNevirapine QD+BIDAtazanvir/Ritonavir
Change in Framingham score to Week 480.50 ± 2.790.66 ± 2.92
Change in Framingham score to Week 960.93 ± 3.151.19 ± 3.25
Change in Framingham score to Week 144/EOT1.14 ± 3.400.82 ± 3.03
SecondaryChange in Mental Health Summary (MHS) Score From Baseline

Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

Time frame:
From baseline to Weeks 48, 96 and 144/EOT
Reported as:
Mean · Units on a scale
Change in Mental Health Summary (MHS) Score From Baseline
Units on a scaleNevirapine QD+BIDAtazanvir/Ritonavir
Change in MHS score to Week 486.09 ± 9.314.52 ± 7.84
Change in MHS score to Week 966.10 ± 9.754.89 ± 9.58
Change in MHS score to Week 144/EOT4.76 ± 10.334.70 ± 10.14
SecondaryChange in Physical Health Summary (PHS) Score From Baseline

QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

Time frame:
From baseline to Weeks 48, 96 and 144/EOT
Reported as:
Mean · Units on a scale
Change in Physical Health Summary (PHS) Score From Baseline
Units on a scaleNevirapine QD+BIDAtazanvir/Ritonavir
Change in PHS score to Week 483.34 ± 7.773.35 ± 8.52
Change in PHS score to Week 963.19 ± 7.833.00 ± 7.34
Change in PHS score to Week 144/EOT2.22 ± 8.773.35 ± 8.42
SecondaryNumber of Patients Hospitalized

Cost effectiveness assessment by number of patients hospitalized

Time frame:
From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT
Reported as:
Number · Patients
Number of Patients Hospitalized
PatientsNevirapine QD+BIDAtazanvir/Ritonavir
Number hospitalized between baseline and Week 2482
Number hospitalized between Week 24 and Week 4865
Number hospitalized between Week 48 and Week 9655
Number hospitalized between Week 96 and Wk 144/EOT91
SecondaryNon-scheduled Physician Visits

Cost effectiveness assessment by number of patients with non-scheduled physician visits

Time frame:
From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT
Reported as:
Number · patients
Non-scheduled Physician Visits
patientsNevirapine QD+BIDAtazanvir/Ritonavir
Number between baseline and Week 247435
Number between Week 24 and Week 484535
Number between Week 48 and Week 965828
Number between Week 96 and Wk 144/EOT5835
SecondaryGenotypic Resistance Associated With Virologic Failure

Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.

Time frame:
From baseline to Week 48
Reported as:
Number · Number of substitutions
Genotypic Resistance Associated With Virologic Failure
Number of substitutionsNevirapine QD+BIDAtazanvir/Ritonavir
Emtricitabine-associated substitutions at Week 48210
Tenofovir-associated substitutions at Week 48110
Nevirapine-associated substitutions at Week 48340
SecondaryTreatment-emergent AIDS-defining Illness

Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment

Time frame:
From baseline to Week 144
Reported as:
Number · Patients
Treatment-emergent AIDS-defining Illness
PatientsNevirapine QD+BIDAtazanvir/Ritonavir
Number with tr.-emerg. AIDS-def.illness267
Number without tr.-emerg. AIDS-def.illness350186
SecondaryTreatment-emergent AIDS-defining Illness Leading to Death

Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.

Time frame:
From baseline to Week 144
Reported as:
Number · Patients
Treatment-emergent AIDS-defining Illness Leading to Death
PatientsNevirapine QD+BIDAtazanvir/Ritonavir
Number with AIDS-def. illness leading to death30
Number without AIDS-def. illness leading to death373193
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Regression, Cox · p = 0.0403 · Hazard ratio (hr): 0.461 · 95% CI 0.220 to 0.966
SecondaryLipodystrophy

Number of patients with AE lipodystrophy

Time frame:
From baseline to Week 144
Reported as:
Number · Patients
Lipodystrophy
PatientsNevirapine QD+BIDAtazanvir/Ritonavir
Number with lipodystrophy11
Number without lipodystrophy375192
SecondarySerum Lipid Abnormalities

Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)

Time frame:
From baseline to Week 144
Reported as:
Number · patients
Serum Lipid Abnormalities
patientsNevirapine QD+BIDAtazanvir/Ritonavir
Number with serum lipid abnormalities94
Number without serum lipid abnormalities367189
SecondaryGlycaemic Abnormalities

Number of patients with AE elevated serum glucose

Time frame:
From baseline to Week 144
Reported as:
Number · Patients
Glycaemic Abnormalities
PatientsNevirapine QD+BIDAtazanvir/Ritonavir
Number with glycaemic abnormalities03
Number without glycaemic abnormalities376190
SecondaryTreatment Response at Week 96

Treatment response is defined as a viral load (VL) \<50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.

Time frame:
From baseline to Week 96
Reported as:
Number · participants
Treatment Response at Week 96
participantsNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
Number of responders131122253149
Number of non-responders576612344
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.0109 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): -0.097 · 95% CI -0.171 to -0.022Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients
  • Nevirapine QD vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.1033 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): -0.072 · 95% CI -0.158 to 0.015Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
  • Nevirapine BID vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.0073 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): -0.122 · 95% CI -0.212 to -0.033Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
SecondaryTreatment Response at Week 144

Treatment response is defined as a viral load (VL) \<50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.

Time frame:
From baseline to Week 144
Reported as:
Number · participants
Treatment Response at Week 144
participantsNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
Number of responders121113234143
Number of non-responders677514250
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.0031 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): -0.117 · 95% CI -0.194 to -0.040Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.
  • Nevirapine QD vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.0365 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): -0.096 · 95% CI -0.186 to -0.006Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.
  • Nevirapine BID vs Atazanvir/Ritonavir · Cochran-Mantel-Haenszel · p = 0.0033 (Test for superiority following confirmation of non-inferiority) · Risk difference (rd): -0.139 · 95% CI -0.231 to -0.046Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.
SecondaryProportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

Time frame:
at Week 24, 48, 96, 144
Reported as:
Number · participants
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
participantsNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
virologic rebound after CVR at Week 243255
virologic rebound after CVR at Week 4845912
virologic rebound after CVR at Week 96461010
virologic rebound after CVR at Week 144891715
SecondaryProportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

Time frame:
at Week 24, 48, 96, 144
Reported as:
Number · participants
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
participantsNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
virologic rebound after CVR at Week 242242
virologic rebound after CVR at Week 483362
virologic rebound after CVR at Week 963692
virologic rebound after CVR at Week 14446105
SecondaryProportion of Patients With Virologic Failure at Week 48, 96, 144
Time frame:
at Week 48, 96, 144
Reported as:
Number · participants
Proportion of Patients With Virologic Failure at Week 48, 96, 144
participantsNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
virologic failure at Week 4820254525
virologic failure at Week 9615254013
virologic failure at Week 14419284717
Statistical analysis
  • Nevirapine BID vs Atazanvir/Ritonavir · Cochran Chi-Squared · p = 0.9784 · Difference in proportions: 0.001 · 95% CI -0.065 to 0.066
  • Nevirapine BID vs Atazanvir/Ritonavir · Cochran Chi-Squared · p = 0.0331 · Difference in proportions: 0.064 · 95% CI 0.005 to 0.123
  • Nevirapine BID vs Atazanvir/Ritonavir · Cochran Chi-Squared · p = 0.0691 · Difference in proportions: 0.058 · 95% CI -0.005 to 0.121
  • Nevirapine QD vs Atazanvir/Ritonavir · Cochran Chi-Squared · p = 0.4585 · Difference in proportions: -0.023 · 95% CI -0.084 to 0.038
  • Nevirapine QD vs Atazanvir/Ritonavir · Cochran Chi-Squared · p = 0.5438 · Difference in proportions: 0.015 · 95% CI -0.034 to 0.064
  • Nevirapine QD vs Atazanvir/Ritonavir · Cochran Chi-Squared · p = 0.5659 · Difference in proportions: 0.016 · 95% CI -0.039 to 0.071
SecondaryTime to Treatment Response (First Confirmed VL<50 Copies/mL)

Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response

Time frame:
baseline to week 144
Reported as:
Median · weeks
Time to Treatment Response (First Confirmed VL<50 Copies/mL)
weeksNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
Time to Treatment Response (First Confirmed VL<50 Copies/mL)12.00 (8.00 to 24.00)12.14 (8.00 to 24.00)12.00 (8.00 to 24.00)23.71 (11.29 to 25.14)
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Regression, Cox · p = 0.0002 · Hazard ratio (hr): 0.692 · 95% CI 0.570 to 0.839
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Regression, Cox · p = <0.0001 · Hazard ratio (hr): 0.630 · 95% CI 0.519 to 0.764
SecondaryTime to Loss of Virologic Response (Rebound)

Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.

Time frame:
Baseline to week 144
Reported as:
Median · weeks
Time to Loss of Virologic Response (Rebound)
weeksNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
Time to Loss of Virologic Response (Rebound)143.86 (48.43 to 144.00)143.21 (0.00 to 144.00)143.71 (4.29 to 144.00)143.00 (119.29 to 144.00)
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Regression, Cox · p = 0.1329 · Hazard ratio (hr): 0.762 · 95% CI 0.535 to 1.086
SecondaryTime to Treatment Failure

Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count \< 50 copies/mL up to Visit 10 (week 48) or loss of virologic response

Time frame:
baseline to week 144
Reported as:
Median · weeks
Time to Treatment Failure
weeksNevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
Time to Treatment Failure143.86 (48.43 to 144.00)143.21 (0.00 to 144.00)143.71 (30.07 to 144.00)143.00 (119.29 to 144.00)
Statistical analysis
  • Nevirapine QD+BID vs Atazanvir/Ritonavir · Regression, Cox · p = 0.0444 · Hazard ratio (hr): 0.731 · 95% CI 0.539 to 0.992
SecondaryChange in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144

Calculations based on the MDRD algorithm.

Time frame:
From baseline to Week 48, 96, 144
Reported as:
Mean · mL/min/1.73 m^2
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
mL/min/1.73 m^2Nevirapine QDNevirapine BIDNevirapine QD+BIDAtazanvir/Ritonavir
change baseline to week 48 (N=143, 128, 271, 173)-3.91 ± 13.93-5.92 ± 17.11-4.86 ± 15.52-7.18 ± 15.19
change baseline to week 96 (N=130, 122, 252, 157)-6.93 ± 14.33-10.02 ± 17.37-8.42 ± 15.92-11.53 ± 15.59
change baseline to week 144 (N=163, 168, 331, 174)-3.27 ± 20.65-6.33 ± 17.30-4.82 ± 19.06-9.56 ± 17.47
SecondaryProportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
Time frame:
week 148
Reported as:
Number · participants
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
participantsNevirapine QDNevirapine BIDAtazanvir/Ritonavir
DAIDS 2 moderate748472
DAIDS 3 severe302839
DAIDS 4 potential lifethreatening9159
SecondaryProportion of Patients Reporting Rash of Any Severity

Proportion of Patients reporting rash of any severity

Time frame:
week 148
Reported as:
Number · participants
Proportion of Patients Reporting Rash of Any Severity
participantsNevirapine QDNevirapine BIDAtazanvir/Ritonavir
Proportion of Patients Reporting Rash of Any Severity756474
SecondaryProportion of Patients Reporting Hepatic Events of Any Severity

Proportion of Patients reporting hepatic events of any severity

Time frame:
week 148
Reported as:
Number · participants
Proportion of Patients Reporting Hepatic Events of Any Severity
participantsNevirapine QDNevirapine BIDAtazanvir/Ritonavir
Proportion of Patients Reporting Hepatic Events of Any Severity262492
SecondaryProportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity

Proportion of Patients reporting CNS (central nervous system) side effects of any severity

Time frame:
week 148
Reported as:
Number · participants
Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
participantsNevirapine QDNevirapine BIDAtazanvir/Ritonavir
Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity414137
SecondaryChange of Cholesterol Values From Baseline to Week 48, 96, 144

Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL

Time frame:
baseline to week 48, 96, 144
Reported as:
Mean · mg/dL
Change of Cholesterol Values From Baseline to Week 48, 96, 144
mg/dLNevirapine QDNevirapine BIDAtazanvir/Ritonavir
total cholesterol, week 48 (N=138,122,164)29.28 ± 30.6429.54 ± 27.3320.84 ± 30.46
total cholesterol, week 96 (N=124,114,147)39.17 ± 33.6736.87 ± 30.6029.99 ± 31.93
total cholesterol, week 144 (N=154,155,160)33.12 ± 32.7730.66 ± 33.2428.13 ± 32.06
LDL-c, week 48 (N=136,117,159)16.54 ± 24.4417.70 ± 22.1610.58 ± 26.07
LDL-c, week 96 (N=119,110,145)21.93 ± 23.4421.66 ± 25.1419.19 ± 25.49
LDL-c, week 144 (N=151,150,157)21.42 ± 26.6117.95 ± 26.0417.61 ± 28.33
HDL, week 48(N=138,122,164)12.06 ± 9.7211.59 ± 10.953.49 ± 9.44
HDL, week 96 (N=124,114,147)13.86 ± 10.9513.33 ± 12.004.74 ± 10.62
HDL, week 144(N=154,155,160)12.61 ± 13.6410.47 ± 15.355.73 ± 11.14
SecondaryChanges of Apolipoprotein Values From Baseline to Week 48, 96, 144

Changes frombaseline apolipoprotein A1 \& B

Time frame:
baseline to week 48, 96, 144
Reported as:
Mean · g/L
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
g/LNevirapine QDNevirapine BIDAtazanvir/Ritonavir
apolipoprotein A1, week 48 (N=134,121,156)0.23 ± 0.220.23 ± 0.240.08 ± 0.21
apolipoprotein A1, week 96 (N=115,106,141)0.23 ± 0.240.23 ± 0.250.07 ± 0.22
apolipoprotein A1, week 144 (N=144,140,148)0.16 ± 0.240.14 ± 0.260.06 ± 0.23
apolipoprotein B, week 48 (N=134,120,156)0.00 ± 0.170.03 ± 0.160.03 ± 0.16
apolipoprotein B, week 96 (N=115,106,141)0.00 ± 0.16-0.00 ± 0.170.03 ± 0.17
apolipoprotein B, week 144 (N=144,139,148)0.01 ± 0.160.05 ± 0.180.03 ± 0.17
SecondaryChange of hsCRP From Baseline to Week 48, 96, 144

Change of hsCRP from baseline to week 48, 96, 144

Time frame:
baseline to week 48, 96, 144
Reported as:
Mean · mg/L
Change of hsCRP From Baseline to Week 48, 96, 144
mg/LNevirapine QDNevirapine BIDAtazanvir/Ritonavir
hsCRP, week 48 (N=142,126,173)-1.01 ± 12.53-0.67 ± 12.71-0.70 ± 8.61
hsCRP, week 96 (N=128,120,157)-1.54 ± 11.21-0.79 ± 21.320.35 ± 15.19
hsCRP, week 144 (N=160,164,174)-0.09 ± 14.34-0.02 ± 12.760.04 ± 8.20
SecondaryChange of Total Triglycerides From Baseline to Week 48, 96, 144

Change of total triglycerides from baseline to week 48, 96, 144

Time frame:
baseline to week 48, 96, 144
Reported as:
Mean · mg/dL
Change of Total Triglycerides From Baseline to Week 48, 96, 144
mg/dLNevirapine QDNevirapine BIDAtazanvir/Ritonavir
total triglycerides, week 48 (N=138,120,164)0.08 ± 92.391.67 ± 99.3136.28 ± 80.24
total triglycerides, week 96 (N=124,113,147)9.34 ± 95.665.35 ± 84.9230.45 ± 94.99
total triglycerides, week 144 (N=153,153,159)-3.46 ± 77.976.11 ± 80.8227.11 ± 85.97
SecondaryChange of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144

Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144

Time frame:
baseline to week 48, 96, 144
Reported as:
Mean · ratio
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
ratioNevirapine QDNevirapine BIDAtazanvir/Ritonavir
total triglycerides, week 48 (N=138,122,164)-0.37 ± 0.95-0.33 ± 1.050.20 ± 0.99
total triglycerides, week 96 (N=124,114,147)-0.22 ± 0.93-0.25 ± 1.030.28 ± 1.05
total triglycerides, week 144 (N=154,155,160)-0.24 ± 0.96-0.07 ± 1.450.17 ± 1.05

Adverse events

Collected over 148 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nevirapine QD—25/188 (13.3%)136/188 (72.3%)
Nevirapine BID—31/188 (16.5%)141/188 (75%)
Atazanvir/Ritonavir—27/193 (14%)161/193 (83.4%)
Most frequent serious events
Showing 10 of 112
Most frequent serious events
EventNevirapine QDNevirapine BIDAtazanvir/Ritonavir
Anogenital wartsInfections and infestations0/1880/1885/193
PyrexiaGeneral disorders1/1883/1880/193
CholelithiasisHepatobiliary disorders0/1883/1880/193
PneumoniaInfections and infestations2/1880/1883/193
AnaemiaBlood and lymphatic system disorders0/1882/1880/193
Upper limb fractureInjury, poisoning and procedural complications1/1882/1880/193
Hodgkin's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/1882/1880/193
Non-Hodgkin's lymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1882/1880/193
Cerebrovascular accidentNervous system disorders0/1882/1880/193
Hepatitis AInfections and infestations0/1880/1882/193
Most frequent other events
Showing 10 of 33
Most frequent other events
EventNevirapine QDNevirapine BIDAtazanvir/Ritonavir
DiarrhoeaGastrointestinal disorders29/18833/18847/193
NasopharyngitisInfections and infestations41/18836/18840/193
JaundiceHepatobiliary disorders0/1880/18840/193
HeadacheNervous system disorders27/18824/18835/193
Blood bilirubin increasedInvestigations0/1881/18833/193
RashSkin and subcutaneous tissue disorders25/18831/18823/193
BronchitisInfections and infestations28/18819/18819/193
NauseaGastrointestinal disorders22/18821/18821/193
CoughRespiratory, thoracic and mediastinal disorders18/18822/18821/193
InfluenzaInfections and infestations21/18818/18816/193

Baseline characteristics

Age, Continuous
Age, Continuous(years)Nevirapine QDNevirapine BIDAtazanvir/RitonavirTotal
Mean38.4 ± 9.740.0 ± 10.537.6 ± 9.538.6 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)Nevirapine QDNevirapine BIDAtazanvir/RitonavirTotal
Female36253192
Male152163162477
Baseline HIV viral load category
Baseline HIV viral load category(participants)Nevirapine QDNevirapine BIDAtazanvir/RitonavirTotal
Baseline HIV viral load ≤ 100,000 copies/mL717165207
Baseline HIV viral load > 100,000 copies/mL117117128362
Baseline log10 HIV viral load
Baseline log10 HIV viral load(log 10 Copies/mL)Nevirapine QDNevirapine BIDAtazanvir/RitonavirTotal
Mean5.1 ± 0.75.1 ± 0.65.1 ± 0.75.1 ± 0.7
Baseline CD4+ cell count
Baseline CD4+ cell count(Cells/mm^3)Nevirapine QDNevirapine BIDAtazanvir/RitonavirTotal
Mean183.3 ± 95.5202.9 ± 93.6193.2 ± 95.8193.2 ± 95.1
08

Study locations

68 sites
  • 1100.1470.54004 Boehringer Ingelheim Investigational Site
    Capital Federal, Argentina
  • 1100.1470.54002 Boehringer Ingelheim Investigational Site
    Córdoba, Argentina
  • 1100.1470.54003 Boehringer Ingelheim Investigational Site
    Mar del Plata, Argentina
  • 1100.1470.54001 Boehringer Ingelheim Investigational Site
    Rosario, Argentina
  • 1100.1470.49001 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 1100.1470.49002 Boehringer Ingelheim Investigational Site
    Berlin, Germany
  • 1100.1470.49003 Boehringer Ingelheim Investigational Site
    Bochum, Germany
  • 1100.1470.49018 Boehringer Ingelheim Investigational Site
    Bonn, Germany
  • 1100.1470.49014 Boehringer Ingelheim Investigational Site
    Düsseldorf, Germany
  • 1100.1470.49008 Boehringer Ingelheim Investigational Site
    Erlangen, Germany
  • 1100.1470.49036 Boehringer Ingelheim Investigational Site
    Frankfurt am Main, Germany
  • 1100.1470.49035 Boehringer Ingelheim Investigational Site
    Frankfurt, Germany
  • 1100.1470.49033 Boehringer Ingelheim Investigational Site
    Freiburg/Breisgau, Germany
  • 1100.1470.49016 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 1100.1470.49031 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 1100.1470.49037 Boehringer Ingelheim Investigational Site
    Hamburg, Germany
  • 1100.1470.49020 Boehringer Ingelheim Investigational Site
    Hannover, Germany
  • 1100.1470.49038 Boehringer Ingelheim Investigational Site
    Magdeburg, Germany
  • 1100.1470.49034 Boehringer Ingelheim Investigational Site
    München, Germany
  • 1100.1470.49000 Boehringer Ingelheim Investigational Site
    Ulm, Germany
  • 1100.1470.49032 Boehringer Ingelheim Investigational Site
    Würzburg, Germany
  • 1100.1470.39001 Boehringer Ingelheim Investigational Site
    Bergamo, Italy
  • 1100.1470.39003 Boehringer Ingelheim Investigational Site
    Bologna, Italy
  • 1100.1470.39012 Ospedale Sant'Anna
    Como, Italy
  • 1100.1470.39006 Boehringer Ingelheim Investigational Site
    Ferrara, Italy
  • 1100.1470.39010 Boehringer Ingelheim Investigational Site
    Lecco, Italy
  • 1100.1470.39004 Boehringer Ingelheim Investigational Site
    Torino, Italy
  • 1100.1470.39009 Boehringer Ingelheim Investigational Site
    Torrette Di Ancona, Italy
  • 1100.1470.39007 Boehringer Ingelheim Investigational Site
    Varese, Italy
  • 1100.1470.55006 Boehringer Ingelheim Investigational Site
    Aguascalientes, Mexico
  • 1100.1470.55004 Boehringer Ingelheim Investigational Site
    Col Obregón, Mexico
  • 1100.1470.55008 Boehringer Ingelheim Investigational Site
    Col. Los Filtros, San Luis Potosí, Mexico
  • 1100.1470.55001 Boehringer Ingelheim Investigational Site
    Col. Toriello Guerra, Mexico
  • 1100.1470.55007 Boehringer Ingelheim Investigational Site
    Guadalajara Jal., Mexico
  • 1100.1470.55003 Boehringer Ingelheim Investigational Site
    Tlalpan-México D,F, Mexico
  • 1100.1470.48003 Boehringer Ingelheim Investigational Site
    Bydgoszcz, Poland
  • 1100.1470.48001 Boehringer Ingelheim Investigational Site
    Chorzow, Poland
  • 1100.1470.48002 Boehringer Ingelheim Investigational Site
    Szczecin, Poland
  • 1100.1470.48004 Boehringer Ingelheim Investigational Site
    Warsaw, Poland
  • 1100.1470.35102 Boehringer Ingelheim Investigational Site
    Cascais, Portugal
  • 1100.1470.35101 Boehringer Ingelheim Investigational Site
    Lisboa, Portugal
  • 1100.1470.35103 Boehringer Ingelheim Investigational Site
    Porto, Portugal
  • 1100.1470.40001 Boehringer Ingelheim Investigational Site
    Bucharest, Romania
  • 1100.1470.40002 Boehringer Ingelheim Investigational Site
    Bucharest, Romania
  • 1100.1470.34013 Boehringer Ingelheim Investigational Site
    Alcalá de Henares (Madrid), Spain
  • 1100.1470.34008 Boehringer Ingelheim Investigational Site
    Badalona, Spain
  • 1100.1470.34002 Boehringer Ingelheim Investigational Site
    Barcelona, Spain
  • 1100.1470.34003 Boehringer Ingelheim Investigational Site
    Barcelona, Spain
  • 1100.1470.34009 Boehringer Ingelheim Investigational Site
    L'Hospitalet de Llobregat, Spain
  • 1100.1470.34010 Boehringer Ingelheim Investigational Site
    Madrid, Spain
  • 1100.1470.34012 Boehringer Ingelheim Investigational Site
    Madrid, Spain
  • 1100.1470.34014 Boehringer Ingelheim Investigational Site
    Madrid, Spain
  • 1100.1470.34015 Boehringer Ingelheim Investigational Site
    Madrid, Spain
  • 1100.1470.34019 Boehringer Ingelheim Investigational Site
    Malaga, Spain
  • 1100.1470.34007 Boehringer Ingelheim Investigational Site
    Sabadell (Barcelona), Spain
  • 1100.1470.34004 Boehringer Ingelheim Investigational Site
    San Sebastian, Spain
  • 1100.1470.34006 Boehringer Ingelheim Investigational Site
    Santa Cruz de Tenerife, Spain
  • 1100.1470.34011 Boehringer Ingelheim Investigational Site
    Vigo, Spain
  • 1100.1470.41004 Boehringer Ingelheim Investigational Site
    Bern, Switzerland
  • 1100.1470.41001 Boehringer Ingelheim Investigational Site
    Lugano, Switzerland
  • 1100.1470.41003 Boehringer Ingelheim Investigational Site
    St. Gallen, Switzerland
  • 1100.1470.41002 Boehringer Ingelheim Investigational Site
    Zürich, Switzerland
  • 1100.1470.44004 Boehringer Ingelheim Investigational Site
    Birmingham, United Kingdom
  • 1100.1470.44001 Boehringer Ingelheim Investigational Site
    London, United Kingdom
  • 1100.1470.44002 Boehringer Ingelheim Investigational Site
    London, United Kingdom
  • 1100.1470.44005 Boehringer Ingelheim Investigational Site
    London, United Kingdom
  • 1100.1470.44006 Boehringer Ingelheim Investigational Site
    London, United Kingdom
  • 1100.1470.44003 Boehringer Ingelheim Investigational Site
    Manchester, United Kingdom
09

References and documents

Publications

  • Seclen E, Soriano V, Gonzalez MM, Martin-Carbonero L, Gellermann H, Distel M, Kadus W, Poveda E. Impact of baseline HIV-1 tropism on viral response and CD4 cell count gains in HIV-infected patients receiving first-line antiretroviral therapy. J Infect Dis. 2011 Jul 1;204(1):139-44. doi: 10.1093/infdis/jir218. PubMed 21628668 ↗
  • Soriano V, Arasteh K, Migrone H, Lutz T, Opravil M, Andrade-Villanueva J, Antunes F, Di Perri G, Podzamczer D, Taylor S, Domingo P, Gellermann H, de Rossi L; ARTEN investigators. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther. 2011;16(3):339-48. doi: 10.3851/IMP1745. PubMed 21555816 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00389207
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 18, 2006
Start date
Oct 2006
Primary completion
Feb 2011
Results posted
Mar 26, 2012
Last update
Jan 27, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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