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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00426660
Registration number
NCT00426660
Ethics application status
Date submitted
22/01/2007
Date registered
25/01/2007
Date last updated
29/06/2016
Titles & IDs
Public title
Expanded Access Program for Maraviroc At Multiple Centers
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Scientific title
A Multicenter, Open Label, Expanded Access Trial Of Maraviroc
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Secondary ID [1]
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2006-004306-50
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Secondary ID [2]
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A4001050
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Condition category
Condition code
Infection
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0
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - maraviroc
Experimental: 1 -
Treatment: Drugs: maraviroc
The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE)
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Assessment method [1]
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AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.
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Timepoint [1]
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Baseline up to Week 144
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Primary outcome [2]
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Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities
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Assessment method [2]
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Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.
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Timepoint [2]
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Baseline up to Week 144
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Primary outcome [3]
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Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities
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Assessment method [3]
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Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.
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Timepoint [3]
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0
Baseline up to Week 144
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Primary outcome [4]
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Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses
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Assessment method [4]
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Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.
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Timepoint [4]
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0
Baseline up to Week 144
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Primary outcome [5]
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Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load
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Assessment method [5]
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0
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Timepoint [5]
0
0
Baseline up to Week 144
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Primary outcome [6]
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Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts
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Assessment method [6]
0
0
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Timepoint [6]
0
0
Baseline up to Week 144
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Primary outcome [7]
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Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy
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Assessment method [7]
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0
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Timepoint [7]
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0
Baseline up to Week 144
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Primary outcome [8]
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Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender
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Assessment method [8]
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Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.
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Timepoint [8]
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0
Baseline up to Week 144
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Primary outcome [9]
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Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race
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Assessment method [9]
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Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.
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Timepoint [9]
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0
Baseline up to Week 144
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Primary outcome [10]
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Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age
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Assessment method [10]
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Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.
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Timepoint [10]
0
0
Baseline up to Week 144
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Primary outcome [11]
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Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status
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Assessment method [11]
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Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.
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Timepoint [11]
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0
Baseline up to Week 144
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Secondary outcome [1]
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Percentage of Participants With =0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA)
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Assessment method [1]
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Defined as HIV-1 RNA levels \< 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.
Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.
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Timepoint [1]
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0
Baseline up to Week 144
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Secondary outcome [2]
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Percentage of Participants With =1.0 log10 Reduction From Baseline in HIV 1 RNA
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Assessment method [2]
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Defined as HIV-1 RNA levels \< 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.
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Timepoint [2]
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Baseline up to Week 144
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Secondary outcome [3]
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Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL
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Assessment method [3]
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Limit of quantification defined as \<400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.
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Timepoint [3]
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Baseline up to Week 144
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Secondary outcome [4]
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Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL
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Assessment method [4]
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Limit of quantification defined as \<50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.
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Timepoint [4]
0
0
Baseline up to Week 144
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Secondary outcome [5]
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Change From Baseline in CD4 Cell Count
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Assessment method [5]
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Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.
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Timepoint [5]
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0
Baseline up to Week 144
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Secondary outcome [6]
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Change From Baseline in CD4 Cell Count Percent
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Assessment method [6]
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Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
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Timepoint [6]
0
0
Baseline up to Week 144
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Secondary outcome [7]
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Change From Baseline in CD8 Cell Count
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Assessment method [7]
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Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.
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Timepoint [7]
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0
Baseline up to Week 144
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Secondary outcome [8]
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Change From Baseline in CD8 Cell Count Percent
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Assessment method [8]
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Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.
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Timepoint [8]
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Baseline up to Week 144
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Secondary outcome [9]
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Median Time to Virologic Failure
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Assessment method [9]
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Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA = 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification \[LLOQ\]); or a = 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL \>0.5 log10 copies/mL; or a HIV 1 RNA level of \>1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.
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Timepoint [9]
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Day 1 up to Week 144
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Secondary outcome [10]
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Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure
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Assessment method [10]
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Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA\>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification \[LOQ\]); B) \>=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL \>0.5 log10 copies/ml ; C) HIV-1 RNA \>1000 copies/ml after having achieved an HIV-1 RNA below LOQ.
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Timepoint [10]
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Baseline up to Week 144
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Secondary outcome [11]
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Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure
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Assessment method [11]
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Tropism status (CCR5 \[R5\], CXCR4 \[X4\], Dual Mixed \[DM\], or Non-reportable \[NR\]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA =0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification \[LLOQ\]); or a = 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL \>0.5 log10 copies/mL; or a HIV 1 RNA level of \>1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.
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Timepoint [11]
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Screening up to Week 144
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Secondary outcome [12]
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Number of Participants With Reduced Maraviroc Susceptibility as Defined by Change From Baseline to Time of Virologic Failure in Inhibitory Concentration of 50% (IC 50) and Presence of Plateau
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Assessment method [12]
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Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) \<95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.
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Timepoint [12]
0
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Baseline up to Week 144
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Secondary outcome [13]
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Number of Participants With Emergence of Resistance to Maraviroc as Defined by Genotypic Changes in the V3 Loop of Glycoprotein 120 (gp 120)
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Assessment method [13]
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Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.
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Timepoint [13]
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Baseline up to Week 144
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Eligibility
Key inclusion criteria
* Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA greater than or equal to 1000 copies/ml, at screening
* Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay
* Minimum age must be 16 years or minimum adult age as determined by local regulatory authorities or directed by local law.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
1047
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Darlinghurst
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Recruitment hospital [2]
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St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [3]
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Albion Street Centre - Surry Hills
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Recruitment hospital [4]
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Westmead Hospital - Wentworthville
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Recruitment hospital [5]
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AIDS Medical Centre - Brisbane
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Recruitment hospital [6]
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Infectious Diseases Unit - Herston
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Recruitment hospital [7]
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Infectious Diseases Unit - Adelaide
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Recruitment hospital [8]
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Melbourne Sexual Health Centre - Carlton
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Recruitment hospital [9]
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Clinical Research Unit, Infectious Diseases - Melbourne
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Recruitment hospital [10]
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Northside Clinic - North Fitzroy
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Recruitment hospital [11]
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Prahran Market Clinic - South Yarra
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2010 - Surry Hills
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Recruitment postcode(s) [3]
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2145 - Wentworthville
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Recruitment postcode(s) [4]
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4000 - Brisbane
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Recruitment postcode(s) [5]
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4029 - Herston
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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3053 - Carlton
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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3068 - North Fitzroy
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Recruitment postcode(s) [10]
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3141 - South Yarra
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
0
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United States of America
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State/province [2]
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Arizona
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Country [3]
0
0
United States of America
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State/province [3]
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Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
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California
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Country [5]
0
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United States of America
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State/province [5]
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Colorado
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Country [6]
0
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United States of America
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State/province [6]
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Connecticut
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Country [7]
0
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United States of America
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State/province [7]
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District of Columbia
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Country [8]
0
0
United States of America
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State/province [8]
0
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Florida
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Country [9]
0
0
United States of America
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State/province [9]
0
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Georgia
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Country [10]
0
0
United States of America
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State/province [10]
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Illinois
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Country [11]
0
0
United States of America
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State/province [11]
0
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Kansas
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Country [12]
0
0
United States of America
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State/province [12]
0
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Maryland
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Country [13]
0
0
United States of America
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State/province [13]
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Massachusetts
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Country [14]
0
0
United States of America
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State/province [14]
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Michigan
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Country [15]
0
0
United States of America
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State/province [15]
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Minnesota
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Country [16]
0
0
United States of America
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State/province [16]
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Missouri
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Country [17]
0
0
United States of America
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State/province [17]
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Montana
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Country [18]
0
0
United States of America
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State/province [18]
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New Jersey
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Country [19]
0
0
United States of America
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State/province [19]
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New York
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Country [20]
0
0
United States of America
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State/province [20]
0
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North Carolina
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Country [21]
0
0
United States of America
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State/province [21]
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Ohio
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Country [22]
0
0
United States of America
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State/province [22]
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Oklahoma
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Country [23]
0
0
United States of America
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State/province [23]
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Oregon
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Country [24]
0
0
United States of America
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State/province [24]
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Pennsylvania
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Country [25]
0
0
United States of America
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State/province [25]
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Rhode Island
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0
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United States of America
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State/province [26]
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South Carolina
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0
0
United States of America
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State/province [27]
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Tennessee
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0
0
United States of America
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State/province [28]
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Texas
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Country [29]
0
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United States of America
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State/province [29]
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Virginia
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0
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United States of America
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State/province [30]
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Washington
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Country [31]
0
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United States of America
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State/province [31]
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West Virginia
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Country [32]
0
0
Argentina
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State/province [32]
0
0
Buenos Aires
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Country [33]
0
0
Austria
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State/province [33]
0
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A-1090
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Country [34]
0
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Austria
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State/province [34]
0
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Graz
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0
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Austria
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State/province [35]
0
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Wien
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Country [36]
0
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Belgium
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State/province [36]
0
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Antwerpen
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Country [37]
0
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Belgium
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Bruxelles
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0
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Belgium
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Charleroi
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0
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Belgium
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Gent
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0
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Belgium
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Jette
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0
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Belgium
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Leuven
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Belgium
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Liège
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0
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Canada
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State/province [43]
0
0
Nova Scotia
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Country [44]
0
0
Canada
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State/province [44]
0
0
Ontario
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0
0
Canada
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State/province [45]
0
0
Quebec
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0
0
Chile
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State/province [46]
0
0
RM
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Country [47]
0
0
Costa Rica
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State/province [47]
0
0
San Jose
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Country [48]
0
0
Dominican Republic
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State/province [48]
0
0
Santo Domingo
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Country [49]
0
0
France
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State/province [49]
0
0
Cedex 09
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Country [50]
0
0
France
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State/province [50]
0
0
Cedex 12
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0
0
France
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State/province [51]
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Cedex
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0
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France
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Besancon
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0
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France
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Bobigny Cedex
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0
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France
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Bordeaux Cedex
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0
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France
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Bordeaux
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0
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France
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State/province [56]
0
0
Clermont Ferrand
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Country [57]
0
0
France
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State/province [57]
0
0
Grenoble Cedex 09
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Country [58]
0
0
France
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State/province [58]
0
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La Source
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0
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France
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State/province [59]
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Le Kremlin Bicêtre
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0
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France
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State/province [60]
0
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Lyon Cedex 02
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0
0
France
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State/province [61]
0
0
Lyon Cedex 04
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Country [62]
0
0
France
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State/province [62]
0
0
Montpellier
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Country [63]
0
0
France
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State/province [63]
0
0
Nantes
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Country [64]
0
0
France
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State/province [64]
0
0
Nice Cedex 3, 06
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Country [65]
0
0
France
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State/province [65]
0
0
Paris Cedex 10
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Country [66]
0
0
France
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State/province [66]
0
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Paris CEDEX 14
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Country [67]
0
0
France
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State/province [67]
0
0
Paris cedex 15
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Country [68]
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0
France
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0
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Paris
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Country [69]
0
0
France
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0
Rennes
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Country [70]
0
0
France
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Toulouse
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0
0
France
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Tourcoing
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Freiburg
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Country [77]
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Germany
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Hannover
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Country [78]
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Germany
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Koeln
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Country [79]
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Greece
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Attiki
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Greece
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Athens
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Country [81]
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Greece
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Patras
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Greece
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Piraeus
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Greece
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Thessaloniki
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Hong Kong
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Kowloon
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India
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Karnataka
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India
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Maharashtra
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India
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Tamil Nadu
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Ireland
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Dublin
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Italy
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Bari
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Catania
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Italy
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Chieti Scalo
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Italy
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Ferrara
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Italy
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Firenze
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Italy
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Genova
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Italy
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Milano
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Italy
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Modena
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Italy
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Padova
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Italy
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Pavia
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Italy
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Pescara
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Italy
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Roma
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Italy
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Torino
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Italy
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Torrette di Ancona
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Italy
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Venezia
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Malaysia
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Kelantan
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Malaysia
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Selangor
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Mexico
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DF
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Mexico
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Jalisco
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Mexico
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Mexico Df
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Netherlands
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Utrecht
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Portugal
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Cascais
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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State/province [115]
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Porto
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Country [118]
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0
Romania
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State/province [118]
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0
Sector 2
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Country [119]
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0
Romania
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State/province [119]
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0
Bucharest
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Country [120]
0
0
Romania
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Constanta
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Country [121]
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Romania
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Iasi
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Cantabria
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Spain
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Gijon
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Spain
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La Coruña
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Spain
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Pontevedra
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Spain
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San Sebastian
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Spain
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Santa Cruz de Tenerife
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Spain
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Tarragona
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Spain
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Vizcaya
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Spain
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Cadiz
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Spain
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Cordoba
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Spain
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Granada
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Zürich
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Taiwan
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State/province [141]
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0
Kaohsiung County
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United Kingdom
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Sussex
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Country [143]
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0
United Kingdom
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0
Crumpsall, Manchester
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Country [144]
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0
United Kingdom
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0
Edinburgh
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Country [145]
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0
United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
ViiV Healthcare
Query!
Address
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Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00426660
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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0
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Phone
0
0
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Fax
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0
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Email
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Contact person for public queries
Name
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Phone
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00426660
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