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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00098722
Registration number
NCT00098722
Ethics application status
Date submitted
7/12/2004
Date registered
8/12/2004
Date last updated
16/05/2012
Titles & IDs
Public title
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
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Secondary ID [1]
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0
A4001028
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Universal Trial Number (UTN)
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Trial acronym
MOTIVATE 2
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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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0
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Condition category
Condition code
Infection
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0
0
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 (UK-427,857)
Treatment: Drugs - optimized background therapy
Treatment: Drugs - Maraviroc (UK-427,857)
Treatment: Drugs - optimized background therapy
Treatment: Drugs - optimized background therapy
Experimental: 1 -
Placebo comparator: 2 -
Experimental: 3 -
Treatment: Drugs: Maraviroc (UK-427,857)
maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.
Treatment: Drugs: optimized background therapy
\[OBT (3-6 drugs based on treatment history and resistance testing)\]
Treatment: Drugs: Maraviroc (UK-427,857)
maraviroc (UK-427,857) 150 mg taken twice daily
Treatment: Drugs: optimized background therapy
\[OBT (3-6 drugs based on treatment history and resistance testing)\]
Treatment: Drugs: optimized background therapy
\[OBT (3-6 drugs based on treatment history and resistance testing)\]
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Intervention code [1]
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0
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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Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
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Assessment method [1]
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Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
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Timepoint [1]
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Baseline
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Primary outcome [2]
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0
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
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Assessment method [2]
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Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
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Timepoint [2]
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0
Baseline and Week 24
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Primary outcome [3]
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0
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
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Assessment method [3]
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0
Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
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Timepoint [3]
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0
Baseline and Week 48
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Secondary outcome [1]
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0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
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Assessment method [1]
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0
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Timepoint [1]
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Week 24 and 48
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Secondary outcome [2]
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0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline
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Assessment method [2]
0
0
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Timepoint [2]
0
0
Week 24 and 48
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Secondary outcome [3]
0
0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline
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Assessment method [3]
0
0
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Timepoint [3]
0
0
Week 24 and 48
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Secondary outcome [4]
0
0
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
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Assessment method [4]
0
0
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Timepoint [4]
0
0
Week 24 and 48
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Secondary outcome [5]
0
0
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
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Assessment method [5]
0
0
Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
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Timepoint [5]
0
0
Baseline
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Secondary outcome [6]
0
0
Change From Baseline in CD4 Cell Count at Week 24 and 48
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Assessment method [6]
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0
Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
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Timepoint [6]
0
0
Week 24 and 48
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Secondary outcome [7]
0
0
Change From Baseline in CD8 Cell Count at Week 24 and 48
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Assessment method [7]
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0
Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
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Timepoint [7]
0
0
Week 24 and 48
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Secondary outcome [8]
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0
Time to Virological Failure
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Assessment method [8]
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Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up\[LTFU\];new anti-retroviral drug added \[except background drug change to drug of same class\];or on open label for early non-response or rebound). Failure:at Time 0 if level not \<400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level \<400 copies/mL (2 consecutive visits);failure if level \>=400 copies/mL (2 consecutive visits) or 1 visit \>=400 copies/mL followed by permanent discontinuation of drug or LTFU.
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Timepoint [8]
0
0
Week 48
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Secondary outcome [9]
0
0
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
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Assessment method [9]
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TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
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Timepoint [9]
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0
Baseline to Week 24 and Week 48
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Secondary outcome [10]
0
0
Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
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Assessment method [10]
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Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to \>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
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Timepoint [10]
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0
Screening
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Secondary outcome [11]
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Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
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Assessment method [11]
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Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to \>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
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Timepoint [11]
0
0
Screening and time of failure through Week 24
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Secondary outcome [12]
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0
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48
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Assessment method [12]
0
0
Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to \>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
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Timepoint [12]
0
0
Screening and time of failure through Week 48
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Secondary outcome [13]
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0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
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Assessment method [13]
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Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} \[R5\], C-X-C chemokine receptor type 4 {CXCR4} \[X4\], Dual/Mixed \[DM\], or Non-reportable/Non-phenotypable \[NR/NP\]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load \<500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.
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Timepoint [13]
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0
Baseline and time of failure through Week 24
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Secondary outcome [14]
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0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
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Assessment method [14]
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Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load \<500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.
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Timepoint [14]
0
0
Baseline and time of failure through Week 48
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Secondary outcome [15]
0
0
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
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Assessment method [15]
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0
Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, \>3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.
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Timepoint [15]
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0
Baseline, Week 24 and Week 48
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Eligibility
Key inclusion criteria
* Men or women at least 16 yers of age (or minimum age as determined by local regulatory authorities)
* HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL
* Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks
* Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide
* Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
* A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)
* Effective barrier contraception for WOCBP and males
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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
* Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir)
* Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days
* Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy
* Treatment for an active opportunistic infection, or unexplained temperature >38.5 degrees Celsius for 7 consecutive days
* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up
* Lactating women, or planned pregnancy during the trial period
* Significant renal insufficiency
* Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 days prior to randomization or the expected need for such therapy during the study period
* Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization
* Significantly elevated liver enzymes or cirrhosis
* Significant neutropenia, anemia or thrombocytopenia
* Malabsorption or an inability to tolerate oral medications
* Certain medications
* Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial
* X4- or dual/mixed-tropic virus or repeated assay failure
* Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
1/12/2004
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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
1/04/2011
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Sample size
Target
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Accrual to date
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Final
474
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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0
Pfizer Investigational Site - Burwood
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Recruitment hospital [2]
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Pfizer Investigational Site - Darlinghurst
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Recruitment hospital [3]
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0
Pfizer Investigational Site - Surry Hills
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Recruitment hospital [4]
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Pfizer Investigational Site - Sydney
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Recruitment hospital [5]
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0
Pfizer Investigational Site - Wentworthville
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Recruitment hospital [6]
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Pfizer Investigational Site - Herston
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Recruitment hospital [7]
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0
Pfizer Investigational Site - Miami
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Recruitment hospital [8]
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Pfizer Investigational Site - Melbourne
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Recruitment hospital [9]
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Pfizer Investigational Site - North Fitzroy
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Recruitment hospital [10]
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Pfizer Investigational Site - South Yarra
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Recruitment postcode(s) [1]
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2134 - Burwood
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2010 - Surry Hills
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Recruitment postcode(s) [4]
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2010 - Sydney
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Recruitment postcode(s) [5]
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2145 - Wentworthville
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Recruitment postcode(s) [6]
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4029 - Herston
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Recruitment postcode(s) [7]
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4220 - Miami
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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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United States of America
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Texas
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Virginia
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Liege
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Canada
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Quebec
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France
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Bp1412
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France
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Cedex 02
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France
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Cedex 09
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France
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Cedex 10
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France
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Cedex 12
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France
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Cedex
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France
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Le Kremlin Bicêtre
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France
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Montpellier
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France
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Nantes
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France
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Nice Cedex 3, 06
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France
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Paris, 75
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France
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Paris
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Duesseldorf
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Fuerth
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Koeln
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Germany
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Mannheim
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Germany
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Muenchen
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Germany
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Osnabrueck
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Germany
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Stuttgart
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Germany
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Ulm
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Italy
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Antella (FI)
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0
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Italy
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Brescia
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Italy
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Firenze
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0
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Italy
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Genova
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0
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Italy
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Milano
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0
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Italy
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0
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Modena
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0
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Italy
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Monserrato, CA
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0
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Italy
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0
0
Roma
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0
0
Italy
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State/province [63]
0
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Torino
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0
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Italy
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0
0
Venezia
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Netherlands
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0
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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0
Rotterdam
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0
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Netherlands
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Utrecht
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Gdansk
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Krakow
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Poland
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Szczecin
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Poland
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Warszawa
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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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Cordoba
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Spain
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Madrid
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Spain
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San Sebastian
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Spain
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Sevilla
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Sweden
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Stockholm
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Sweden
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Göteborg
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Sweden
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Malmö
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Switzerland
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Basel
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Switzerland
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Genève
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Switzerland
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Lausanne
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Switzerland
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Lugano
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Switzerland
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St. Gallen
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Switzerland
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Zürich
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United Kingdom
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Leics
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United Kingdom
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Loth
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United Kingdom
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Birmingham
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United Kingdom
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Brighton
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle Upon Tyre
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Funding & Sponsors
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ViiV Healthcare
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Pfizer
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Summary
Brief summary
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \[OBT (3-6 drugs based on treatment history and resistance testing)\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
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Trial website
https://clinicaltrials.gov/study/NCT00098722
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Trial related presentations / publications
Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380. Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a. Hardy WD, Gulick RM, Mayer H, Fatkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82. Fatkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154. Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.
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Public notes
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Results are available at
https://clinicaltrials.gov/study/NCT00098722
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