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Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

29. November 2010 aktualisiert von: Bristol-Myers Squibb

Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

The purpose of this study is to learn how well atazanavir (ATV) works in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

571

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94121
      • Torrance, California, Vereinigte Staaten, 90502
    • Colorado
      • Boulder, Colorado, Vereinigte Staaten, 80304
    • Florida
      • Altamonte Springs, Florida, Vereinigte Staaten
      • Ft Lauderdale, Florida, Vereinigte Staaten, 33308
      • Ft Lauderdale, Florida, Vereinigte Staaten, 33306
      • Miami Beach, Florida, Vereinigte Staaten, 33160
      • Orlando, Florida, Vereinigte Staaten, 32801
    • Georgia
      • Decatur, Georgia, Vereinigte Staaten
    • Hawaii
      • Honolulu, Hawaii, Vereinigte Staaten, 96816
    • Indiana
      • Boise, Indiana, Vereinigte Staaten
    • Kansas
      • Wichita, Kansas, Vereinigte Staaten, 67214
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten
    • Massachusetts
      • Brookline, Massachusetts, Vereinigte Staaten
      • Fall River, Massachusetts, Vereinigte Staaten, 02720
    • New Jersey
      • East Orange, New Jersey, Vereinigte Staaten
      • Newark, New Jersey, Vereinigte Staaten, 07103
    • New York
      • Buffalo, New York, Vereinigte Staaten, 14215
      • Manhasset, New York, Vereinigte Staaten, 11030
      • New York, New York, Vereinigte Staaten, 10019
      • Rochester, New York, Vereinigte Staaten, 14620
    • North Carolina
      • Huntersville, North Carolina, Vereinigte Staaten, 28078
      • Winston Salem, North Carolina, Vereinigte Staaten, 29203
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27157
    • Ohio
      • Akron, Ohio, Vereinigte Staaten
    • Texas
      • Dallas, Texas, Vereinigte Staaten
      • Dallas, Texas, Vereinigte Staaten, 75246
      • Houston, Texas, Vereinigte Staaten, 77006

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

16 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Virologic failure to 2 or more highly active antiretroviral therapy (HAART) regimens that, in total, have included at least one drug from all approved classes protease inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors (PI, NNRTI, NRTI):

    1. Currently on a failing HAART regimen with 2 qualifying plasma viral load measurements (hospital/clinic value within 4 weeks of screening with viral load equivalent to =>1,000 c/mL on the Roche Amplicor[TM] and central lab measurements of =>1,000 c/mL (Roche Amplicor[TM]) within 4 weeks of randomization
    2. Cluster of Differentiation 4 (CD4) cell count =>50 cells/mm3 obtained within 4 weeks prior to randomization
  • =>16 years of age (or minimum age as determined by local regulations or as legal requirements dictate);
  • History of prior virologic response to at least one HAART regimen, defined as a 1.0 log10 decline or a decline in viral load to <400 c/mL by Roche Amplicor or <500 c/mL by Chiron Quantiplex branched DNA (bDNA) assay
  • Both females of child bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted disease, including human immunodeficiency virus (HIV). Other contraception in addition to barrier methods is permitted; interaction between atazanavir and oral contraceptives has not been studied.
  • Subjects must be able to provide written informed consent;
  • Subjects should be available for follow-up for a period of at least 48 weeks

  • Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:

    1. serum creatine <1.5 times the upper limit of normal (ULN)
    2. total serum lipase <1.4 times the ULN
    3. liver enzymes alanine aminotransferase (AST), aspartate aminotransferase (ALT) <3 times the ULN
    4. total serum bilirubin <1.5 times the ULN

Exclusion Criteria:

  • Prior use (=>3 days) of atazanavir, TVF or LPV/RTV; if history of SQV, then must be phenotypically sensitive
  • the current failing antiretroviral regimen must have been administered for at least eight weeks at he initiation of screening and must not include both a PI and NNRTI
  • Presence of a newly diagnosed HIV-related opportunistic infection or any medical requiring acute therapy at the time of enrollment
  • Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes (ALT/AST) are <3 x ULN
  • Previous therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment of therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect Cytochrome P450 3A4 (CYP3A4).
  • Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
  • Intractable diarrhea (=> 6 loose stools/day for at least 7 days consecutive days) within 30 days prior to study entry
  • Pregnancy or breast-feeding
  • History of hemophilia
  • Presence of cardiomyopathy

  • Any one of the following:

    1. Heart rate-corrected QT (QTc) interval >450 msec on the screening electrocardiogram (EKG)
    2. Heart rate <40 beats per minute (bpm)
    3. Pause length >3 seconds seen on EKG
    4. Clinical symptoms potentially related to heart block
    5. Third degree heart block
  • History of acute or chronic pancreatitis
  • If choosing 2'-3' dideoxyinosine (ddI) or 2',3'-didehydro-3'-deoxythymidine (d4T) as the NRTI: History or signs and symptoms of bilateral peripheral neuropathy => Grade 2 at the time of screening
  • Inability to tolerate oral medications
  • Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: I

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Arzneimittel: Atazanavir + ritonavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral
Andere Namen:
  • Reyataz
  • BMS-232632
Aktiver Komparator: II

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Arzneimittel: Atazanavir + saquinavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral
Andere Namen:
  • Reyataz
  • BMS-232632
Aktiver Komparator: III

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Arzneimittel: Lopinavir/ritonavir + tenofovir + nucleoside
Active Comparator, Capsules, tablets, Oral

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24
Zeitfenster: Baseline, Week 24
Baseline, Week 24
Mean Change From Baseline in HIV RNA at Week 48
Zeitfenster: Baseline, Week 48
Baseline, Week 48
Mean Change From Baseline in HIV RNA at Week 96
Zeitfenster: Baseline, Week 96
Baseline, Week 96

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Veränderung der CD4-Zellzahl gegenüber dem Ausgangswert in Woche 24
Zeitfenster: Baseline, Woche 24
Baseline, Woche 24
Veränderung der CD4-Zellzahl gegenüber dem Ausgangswert in Woche 48
Zeitfenster: Baseline, Woche 48
Baseline, Woche 48
Veränderung der CD4-Zellzahl gegenüber dem Ausgangswert in Woche 96
Zeitfenster: Baseline, Woche 96
Baseline, Woche 96
Mean Change From Baseline in HIV RNA at Week 2
Zeitfenster: Baseline, Week 2
Baseline, Week 2
Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)
Zeitfenster: Baseline, Week 24
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.
Baseline, Week 24
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)
Zeitfenster: Baseline, Week 48
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.
Baseline, Week 48
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96
Zeitfenster: Baseline, Week 96
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96.
Baseline, Week 96
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24
Zeitfenster: Week 24
Week 24
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity
Zeitfenster: Baseline, Week 24
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.
Baseline, Week 24
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48
Zeitfenster: Week 48
Week 48
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity
Zeitfenster: Baseline, Week 48
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.
Baseline, Week 48
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96
Zeitfenster: Week 96
Week 96
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24
Zeitfenster: Week 24
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Week 24
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48
Zeitfenster: Week 48
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Week 48
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96
Zeitfenster: Week 96
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Week 96
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24
Zeitfenster: Week 24
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Week 24
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48
Zeitfenster: Week 48
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Week 48
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96
Zeitfenster: Week 96
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Week 96
Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24
Zeitfenster: Baseline, Week 24
Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.
Baseline, Week 24
Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48
Zeitfenster: Baseline, Week 48
Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.
Baseline, Week 48
Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
Zeitfenster: Baseline, Week 24
Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.
Baseline, Week 24
Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48
Zeitfenster: Baseline, Week 48
Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.
Baseline, Week 48
Lipid Mean Percent Change From Baseline at Week 24
Zeitfenster: Baseline, Week 24
Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.
Baseline, Week 24
Lipid Mean Percent Change From Baseline at Week 48
Zeitfenster: Week 48
Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.
Week 48
Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Zeitfenster: Week 96
Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.
Week 96
Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48
Zeitfenster: From Enrollment through Week 48
AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.
From Enrollment through Week 48
Most Common AEs and AEs of Interest Through Week 48
Zeitfenster: From Enrollment to Week 48
Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.
From Enrollment to Week 48
Fasting Glucose Mean Change From Baseline at Week 24
Zeitfenster: Baseline, Week 24
Baseline, Week 24
Fasting Glucose Mean Change From Baseline at Week 48
Zeitfenster: Week 48
Week 48
Grade 3/4 Laboratory Abnormalities Through Week 48
Zeitfenster: From Enrollment to Week 48
Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4).
From Enrollment to Week 48
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point
Zeitfenster: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.
Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48
PR Interval and Change From Baseline by Analysis Time Point
Zeitfenster: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48
The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.
Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48
Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire
Zeitfenster: Baseline, Week 24, Week 48
The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.
Baseline, Week 24, Week 48
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)
Zeitfenster: Baseline, Week 24, Week 48
The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.
Baseline, Week 24, Week 48
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)
Zeitfenster: Baseline, Week 24, Week 48
The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.
Baseline, Week 24, Week 48
Number of Participants Utilizing Resources for Managing Lipid Elevation
Zeitfenster: Baseline, Week 24, Week 48
Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.
Baseline, Week 24, Week 48
Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values
Zeitfenster: collected at the pre-dose time point after receiving atazanavir for at least four weeks
The minimum or "trough" concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose.
collected at the pre-dose time point after receiving atazanavir for at least four weeks
HIV IC50 at Week 24
Zeitfenster: Week 24
IC50: inhibitory concentration of drug required to reduce viral replication by 50%.
Week 24
Inhibitory Quotient at Week 24
Zeitfenster: Baseline, Week 24
Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.
Baseline, Week 24
Inhibitory Quotient at Week 48
Zeitfenster: Baseline, Week 48
Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.
Baseline, Week 48
HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24
Zeitfenster: Baseline, Week 24
Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.
Baseline, Week 24
HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48
Zeitfenster: Baseline, Week 48
Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.
Baseline, Week 48

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bristol-Myers Squibb

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2001

Primärer Abschluss (Tatsächlich)

1. Juli 2003

Studienabschluss (Tatsächlich)

1. März 2009

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2002

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2002

Zuerst gepostet (Schätzen)

8. Mai 2002

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

24. Dezember 2010

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. November 2010

Zuletzt verifiziert

1. November 2010

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AI424-045

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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