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

9 december 2013 uppdaterad av: Boehringer Ingelheim

Randomized, Open Label Study Evaluating the Lipid Profile Difference and Efficacy of a Combined Therapy Including Tenofovir, Emtricitabine + Atazanavir / r or NVP in Naive HIV - 1 Infected Patients.

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

576

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: NVP bid
nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF)
Läkemedel: nevirapine bid
nevirapine twice daily
Experimentell: NVP qd
nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF)
Läkemedel: nevirapine qd
nevirapine once daily
Aktiv komparator: ATZ/r
ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF)
Läkemedel: atazanavir
atazanavir once daily

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Response at Week 48
Tidsram: From baseline to 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.
From baseline to Week 48

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Response at Week 48 (TLOVR Algorithm)
Tidsram: From baseline to Week 48
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.
From baseline to Week 48
Proportion of Patients With VL < 50 Copies/ml
Tidsram: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
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
From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
Proportion of Patients With VL < 400 Copies/ml
Tidsram: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)
From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
Change in CD4+ Count From Baseline
Tidsram: From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT
From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT
Change in Framingham Score From Baseline
Tidsram: From baseline to Weeks 48, 96 and 144/EOT
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.
From baseline to Weeks 48, 96 and 144/EOT
Change in Mental Health Summary (MHS) Score From Baseline
Tidsram: From baseline to Weeks 48, 96 and 144/EOT
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.
From baseline to Weeks 48, 96 and 144/EOT
Change in Physical Health Summary (PHS) Score From Baseline
Tidsram: From baseline to Weeks 48, 96 and 144/EOT
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.
From baseline to Weeks 48, 96 and 144/EOT
Number of Patients Hospitalized
Tidsram: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT
Cost effectiveness assessment by number of patients hospitalized
From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT
Non-scheduled Physician Visits
Tidsram: From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT
Cost effectiveness assessment by number of patients with non-scheduled physician visits
From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT
Genotypic Resistance Associated With Virologic Failure
Tidsram: From baseline to Week 48
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.
From baseline to Week 48
Treatment-emergent AIDS-defining Illness
Tidsram: From baseline to Week 144
Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment
From baseline to Week 144
Treatment-emergent AIDS-defining Illness Leading to Death
Tidsram: From baseline to Week 144
Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.
From baseline to Week 144
Lipodystrophy
Tidsram: From baseline to Week 144
Number of patients with AE lipodystrophy
From baseline to Week 144
Serum Lipid Abnormalities
Tidsram: From baseline to Week 144
Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)
From baseline to Week 144
Glycaemic Abnormalities
Tidsram: From baseline to Week 144
Number of patients with AE elevated serum glucose
From baseline to Week 144
Treatment Response at Week 96
Tidsram: From baseline to 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.
From baseline to Week 96
Treatment Response at Week 144
Tidsram: From baseline to 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.
From baseline to Week 144
Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144
Tidsram: 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)
at Week 24, 48, 96, 144
Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144
Tidsram: 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)
at Week 24, 48, 96, 144
Proportion of Patients With Virologic Failure at Week 48, 96, 144
Tidsram: at Week 48, 96, 144
at Week 48, 96, 144
Time to Treatment Response (First Confirmed VL<50 Copies/mL)
Tidsram: baseline to week 144
Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response
baseline to week 144
Time to Loss of Virologic Response (Rebound)
Tidsram: Baseline to week 144
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.
Baseline to week 144
Time to Treatment Failure
Tidsram: baseline to week 144
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
baseline to week 144
Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144
Tidsram: From baseline to Week 48, 96, 144
Calculations based on the MDRD algorithm.
From baseline to Week 48, 96, 144
Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities
Tidsram: week 148
week 148
Proportion of Patients Reporting Rash of Any Severity
Tidsram: week 148
Proportion of Patients reporting rash of any severity
week 148
Proportion of Patients Reporting Hepatic Events of Any Severity
Tidsram: week 148
Proportion of Patients reporting hepatic events of any severity
week 148
Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity
Tidsram: week 148
Proportion of Patients reporting CNS (central nervous system) side effects of any severity
week 148
Change of Cholesterol Values From Baseline to Week 48, 96, 144
Tidsram: baseline to week 48, 96, 144
Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL
baseline to week 48, 96, 144
Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144
Tidsram: baseline to week 48, 96, 144
Changes frombaseline apolipoprotein A1 & B
baseline to week 48, 96, 144
Change of hsCRP From Baseline to Week 48, 96, 144
Tidsram: baseline to week 48, 96, 144
Change of hsCRP from baseline to week 48, 96, 144
baseline to week 48, 96, 144
Change of Total Triglycerides From Baseline to Week 48, 96, 144
Tidsram: baseline to week 48, 96, 144
Change of total triglycerides from baseline to week 48, 96, 144
baseline to week 48, 96, 144
Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144
Tidsram: baseline to week 48, 96, 144
Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144
baseline to week 48, 96, 144

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2006

Primärt slutförande (Faktisk)

1 februari 2011

Studieregistreringsdatum

Först inskickad

17 oktober 2006

Först inskickad som uppfyllde QC-kriterierna

17 oktober 2006

Första postat (Uppskatta)

18 oktober 2006

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

27 januari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 december 2013

Senast verifierad

1 december 2013

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1100.1470
  • 2005-004330-40 (EudraCT-nummer: EudraCT)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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