Expanded Access Program for Maraviroc At Multiple Centers

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00426660
First received: January 22, 2007
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Advanced HIV Infection
Drug: maraviroc
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open Label, Expanded Access Trial Of Maraviroc

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Percentage of Participants With Grade 3 and Grade 4 Adverse Events (AE) [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Grade 3 Laboratory Abnormalities Without Regards to Baseline Abnormalities [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Grade 4 Laboratory Abnormalities Without Regards to Baseline Abnormalities [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Illnesses [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline Viral Load [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Baseline/Nadir CD4 Cell Counts [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Possible Acquired Immunodeficiency Syndrome (AIDS) Related Infections and Malignancies by Time on Therapy [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With All Causality Treatment-emergent Adverse (AEs) Events by Gender [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Race [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Adverse Events (AEs) by Age [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.

  • Percentage of Participants With Treatment-emergent Averse Events (AEs) by Baseline Hepatitis B and Hepatitis C Virus Serology Status [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: Yes ]
    Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.


Secondary Outcome Measures:
  • Percentage of Participants With ≥0.5 log10 Reduction From Baseline in Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV 1 RNA) [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With ≥1.0 log10 Reduction From Baseline in HIV 1 RNA [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <400 Copies/mL [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With HIV-1 RNA Levels Below the Limit of Quantification: <50 Copies/mL [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in CD4 Cell Count [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in CD4 Cell Count Percent [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Change From Baseline in CD8 Cell Count [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in CD8 Cell Count Percent [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

  • Median Time to Virologic Failure [ Time Frame: Day 1 up to Week 144 ] [ Designated as safety issue: No ]
    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.

  • Emergence of Resistance to Maraviroc [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    Resistance defined by genotypic changes in the V3 loop of HIV 1 viral envelope glycoprotein 120 [gp 120] and/or the entire gp 120 gene associated with decreased susceptibility to maraviroc for participants who meet the definition of virologic failure during the trial.

  • Percentage of Participants With Changes in HIV-1 RNA Level in Participants Meeting the Definition of Virologic Failure [ Time Frame: Baseline up to Week 144 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Change in Chemokine Co-receptor Tropism From Screening to Time of Virologic Failure [ Time Frame: Screening up to Week 144 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1047
Study Start Date: February 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trial or having previously prematurely discontinued Maraviroc in trials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426660

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35294
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Hobson City, Alabama, United States, 36201
United States, Arizona
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Tucson, Arizona, United States, 85745
United States, Arkansas
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Little Rock, Arkansas, United States, 72207
United States, California
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Beverly Hills, California, United States, 90211
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Beverly Hills, California, United States, 90210-4212
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Fountain Valley, California, United States, 92708
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Hayward, California, United States, 94545
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Long Beach, California, United States, 90813
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Los Angeles, California, United States, 90033
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Los Angeles, California, United States, 90048
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Los Angeles, California, United States, 90069
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Los Angeles, California, United States, 90022
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Los Angeles, California, United States, 90027
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Los Angeles, California, United States, 90028
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Los Angeles, California, United States, 90036
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Modesto, California, United States, 95350
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Newport Beach, California, United States, 92663
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Oakland, California, United States, 94604
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Palm Springs, California, United States, 92262
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Riverside, California, United States, 92506
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Sacramento, California, United States, 95816
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San Francisco, California, United States, 94115-3029
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San Francisco, California, United States, 94118
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Santa Clara, California, United States, 95051
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Tarzana, California, United States, 91356
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Victorville, California, United States, 92395
United States, Colorado
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Denver, Colorado, United States, 80220
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Denver, Colorado, United States, 80205
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Lafayette, Colorado, United States, 80026
United States, Connecticut
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Glastonbury, Connecticut, United States, 06033
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Norwich, Connecticut, United States, 06360
United States, District of Columbia
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Washington, District of Columbia, United States, 20009-1104
United States, Florida
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Bonita Springs, Florida, United States, 34134
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Boynton Beach, Florida, United States, 33426
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Cape Coral, Florida, United States, 33990
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Daytona Beach, Florida, United States, 32117
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Fort Lauderdale, Florida, United States, 33316
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Fort Lauderdale, Florida, United States, 33311
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Fort Myers, Florida, United States, 33912
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Ft. Lauderdale, Florida, United States, 33308
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Hollywood, Florida, United States, 33021
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33137
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Miami, Florida, United States, 33133
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Miami Beach, Florida, United States, 33139
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North Miami Beach, Florida, United States, 33162
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North Miami Beach, Florida, United States, 33169
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Orlando, Florida, United States, 32803
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Orlando, Florida, United States, 32806
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Port St Lucie, Florida, United States, 34952
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Safety Harbor, Florida, United States, 34695
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Sarasota, Florida, United States, 34239-2900
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Sarasota, Florida, United States, 34243
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St. Petersburg, Florida, United States, 33701
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Tallahassee, Florida, United States, 32308
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Tampa, Florida, United States, 33606
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Tampa, Florida, United States, 33614
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Tampa, Florida, United States, 33612
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West Palm Beach, Florida, United States, 33401
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Wilton Manors, Florida, United States, 33305
United States, Georgia
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Atlanta, Georgia, United States, 30339
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Atlanta, Georgia, United States, 30329
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Atlanta, Georgia, United States, 30318-2513
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Atlanta, Georgia, United States, 30309
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Atlanta, Georgia, United States, 30318
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Decatur, Georgia, United States, 30033
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Savannah, Georgia, United States, 31405
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Tucker, Georgia, United States, 30084-8128
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Topeka, Kansas, United States, 66606-1670
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Baltimore, Maryland, United States, 21201
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Greenbelt, Maryland, United States, 20770-3525
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Silver Spring, Maryland, United States, 20910
United States, Massachusetts
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Boston, Massachusetts, United States, 02215-3318
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Berkley, Michigan, United States, 48072
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Grand Rapids, Michigan, United States, 49546
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Grosse Pointe Woods, Michigan, United States, 48236
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Keego Harbor, Michigan, United States, 48320
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Lansing, Michigan, United States, 48910
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Minneapolis, Minnesota, United States, 55415
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Kansas City, Missouri, United States, 64111-2610
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St. Louis, Missouri, United States, 63117
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Missoula, Montana, United States, 59802
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Englewood, New Jersey, United States, 07631
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Hackensack, New Jersey, United States, 07601
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Newark, New Jersey, United States, 07103
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Somers Point, New Jersey, United States, 08244
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Toms River, New Jersey, United States, 08755
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Voorhees, New Jersey, United States, 08043
United States, New York
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Albany, New York, United States, 12208
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Bronx, New York, United States, 10023
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Bronx, New York, United States, 10454
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Brooklyn, New York, United States, 11206
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Brooklyn, New York, United States, 11215
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Buffalo, New York, United States, 14215
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Flushing, New York, United States, 11355
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Great Neck, New York, United States, 11021
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Manhasset, New York, United States, 11030
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New York, New York, United States, 10026
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New York, New York, United States, 10011
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New York, New York, United States, 10019-1819
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New York, New York, United States, 10003
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New York, New York, United States, 10018
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New York, New York, United States, 10029
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New York, New York, United States, 10016
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New York, New York, United States, 10032
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New York, New York, United States, 10024
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Rochester, New York, United States, 14605
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Stanton Island, New York, United States, 10304
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Syracuse, New York, United States, 13210
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Gastonia, North Carolina, United States, 28054
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Huntersville, North Carolina, United States, 28078
United States, Ohio
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Cleveland, Ohio, United States, 44109
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Dayton, Ohio, United States, 45429
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Toledo, Ohio, United States, 43614-5812
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74135
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Portland, Oregon, United States, 97227
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Portland, Oregon, United States, 97210
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Allentown, Pennsylvania, United States, 18102
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Philadelphia, Pennsylvania, United States, 19107
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West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
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Providence, Rhode Island, United States, 02906
United States, South Carolina
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Charleston, South Carolina, United States, 29403
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Charleston, South Carolina, United States, 29425
United States, Tennessee
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Memphis, Tennessee, United States, 38119
United States, Texas
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Dallas, Texas, United States, 75204
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Dallas, Texas, United States, 75219
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Dallas, Texas, United States, 75231
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El Paso, Texas, United States, 79925
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Fort Worth, Texas, United States, 76104
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Fort Worth, Texas, United States, 76104-3048
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Ft. Worth, Texas, United States, 76104
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Harlingen, Texas, United States, 78550
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Houston, Texas, United States, 77098-2807
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Houston, Texas, United States, 77009
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77098
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Longview, Texas, United States, 75605
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San Antonio, Texas, United States, 78212
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San Antonio, Texas, United States, 78258
United States, Virginia
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Annandale, Virginia, United States, 22003
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Arlington, Virginia, United States, 22205-3633
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Danville, Virginia, United States, 24541
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Fairfax, Virginia, United States, 22030
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Hampton, Virginia, United States, 23666
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Lynchburg, Virginia, United States, 24501
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Richmond, Virginia, United States, 23224
United States, Washington
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Edmonds, Washington, United States, 98026
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Seattle, Washington, United States, 98112
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Seattle, Washington, United States, 98109
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Spokane, Washington, United States, 99204
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Vancouver, Washington, United States, 98664
United States, West Virginia
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Charleston, West Virginia, United States, 25304
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Huntington, West Virginia, United States, 25701
Argentina
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Buenos Aires, Argentina, C1202ABB
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Buenos Aires, Argentina, C1425AWK
Australia, New South Wales
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Darlinghurst, New South Wales, Australia, 2010
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Surry Hills, New South Wales, Australia, 2010
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Wentworthville, New South Wales, Australia, 2145
Australia, Queensland
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Brisbane, Queensland, Australia, 4000
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Herston, Queensland, Australia, 4029
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Carlton, Victoria, Australia, 3053
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Melbourne, Victoria, Australia, 3004
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North Fitzroy, Victoria, Australia, 3068
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South Yarra, Victoria, Australia, 3141
Austria
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A-1090, Austria
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Graz, Austria, A-8020
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Wien, Austria, A-1140
Belgium
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Antwerpen, Belgium, 2000
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1070
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Bruxelles, Belgium, 1200
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Charleroi, Belgium, 6000
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Gent, Belgium, 9000
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Jette, Belgium, B-1090
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
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Toronto, Ontario, Canada, M5B 1L6
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Montreal, Quebec, Canada, H3H 1V1
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Montreal, Quebec, Canada, H2L 5B1
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Montreal, Quebec, Canada, H2W 1T8
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Montreal, Quebec, Canada, H2L 4P9
Chile
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Santiago, RM, Chile, 8330023
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Santiago, RM, Chile, 8360160
Costa Rica
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Barrio Aranjuez, San Jose, Costa Rica
Dominican Republic
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Santo Domingo, Dominican Republic
France
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Marseille, Cedex 09, France, 13274
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Paris, Cedex 12, France, 75571
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Caen, Cedex, France, 14033
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Besancon, France, 25030
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Bobigny Cedex, France, 93009
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Bordeaux, France, 33076
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Bordeaux Cedex, France, 33075
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Clermont Ferrand, France, 63000
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Grenoble Cedex 09, France, 38043
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La Source, France, 45100
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Le Kremlin Bicêtre, France, 94270
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Lyon Cedex 02, France, 69288
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Lyon Cedex 04, France, 690317
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Montpellier, France, 34295
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Nantes, France, 44093
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Nice Cedex 3, 06, France, 06202
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Paris, France, 75018
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Paris, France, 75015
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Paris, France, 75013
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Paris, France, 75020
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Paris Cedex 10, France, 75475
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Paris CEDEX 14, France, 75679
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Paris cedex 15, France, 75743
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Rennes, France, 35033
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Toulouse, France, 31059
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Tourcoing, France, 59208
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Villejuif, France, 94800
Germany
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Berlin, Germany, 10243
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Dresden, Germany, 01307
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Essen, Germany, 45122
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Freiburg, Germany, 79098
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Hannover, Germany, 30625
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Koeln, Germany, 50937
Greece
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Athens, Attiki, Greece, 10676
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Athens, Attiki, Greece, 115 26
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Athens, Greece, 161 21
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Athens, Greece, 115 27
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Patras, Greece, 265 00
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Piraeus, Greece, 185 36
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Thessaloniki, Greece, 54636
Hong Kong
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Kowloon, Hong Kong
India
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Bangalore, Karnataka, India, 560 034
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Mumbai, Maharashtra, India, 400 026
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Chennai, Tamil Nadu, India, 600 113
Ireland
Pfizer Investigational Site
Dublin, Ireland, 8
Pfizer Investigational Site
Dublin, Ireland, 7
Italy
Pfizer Investigational Site
Bari, Italy, 70124
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Brescia, Italy, 25123
Pfizer Investigational Site
Catania, Italy, 95126
Pfizer Investigational Site
Chieti Scalo, Italy, 66100
Pfizer Investigational Site
Ferrara, Italy, 44100
Pfizer Investigational Site
Firenze, Italy, 50100
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Milano, Italy, 20127
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Padova, Italy, 35128
Pfizer Investigational Site
Pavia, Italy, 27100
Pfizer Investigational Site
Pescara, Italy, 65124
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Roma, Italy, 00133
Pfizer Investigational Site
Roma, Italy, 00184
Pfizer Investigational Site
Roma, Italy, 00149
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Torino, Italy, 10149
Pfizer Investigational Site
Torrette di Ancona, Italy, 60121
Pfizer Investigational Site
Venezia, Italy, 30122
Malaysia
Pfizer Investigational Site
Kota Bharu, Kelantan, Malaysia, 15586
Pfizer Investigational Site
Sungai Buloh, Selangor, Malaysia, 47000
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 01030
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44280
Pfizer Investigational Site
Tlalpan, Mexico Df, Mexico, CP 14000
Netherlands
Pfizer Investigational Site
Utrecht, Netherlands, NL 3584 CX
Portugal
Pfizer Investigational Site
Cascais, Portugal, 2750-349
Pfizer Investigational Site
Lisboa, Portugal, 1169-050
Pfizer Investigational Site
Lisboa, Portugal, 1649-035
Pfizer Investigational Site
Porto, Portugal, 4200-319
Puerto Rico
Pfizer Investigational Site
Ponce, Puerto Rico, 00717-1563
Pfizer Investigational Site
Santurce, Puerto Rico, 00909
Romania
Pfizer Investigational Site
Bucuresti, Sector 2, Romania, 021105
Pfizer Investigational Site
Bucharest, Romania, 030303
Pfizer Investigational Site
Constanta, Romania, 900709
Pfizer Investigational Site
Iasi, Romania, 700116
Spain
Pfizer Investigational Site
Elche, Alicante, Spain, 03202
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08916
Pfizer Investigational Site
Granollers, Barcelona, Spain, 08400
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Basurto, Bilbao, Spain, 48078
Pfizer Investigational Site
Santander, Cantabria, Spain, 39008
Pfizer Investigational Site
Cabueñes, Gijon, Spain, 33394
Pfizer Investigational Site
Santiago de Compostela, La Coruña, Spain, 15706
Pfizer Investigational Site
Vigo, Pontevedra, Spain, 36204
Pfizer Investigational Site
Donostia, San Sebastian, Spain, 20014
Pfizer Investigational Site
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Pfizer Investigational Site
Tortosa, Tarragona, Spain, 43500
Pfizer Investigational Site
Barakaldo, Vizcaya, Spain, 48903
Pfizer Investigational Site
Alicante, Spain, 03010
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Barcelona, Spain, 08025
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Cadiz, Spain, 11009
Pfizer Investigational Site
Cordoba, Spain, 14012
Pfizer Investigational Site
Granada, Spain, 18012
Pfizer Investigational Site
Granada, Spain, 18014
Pfizer Investigational Site
Madrid, Spain, 28007
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Madrid, Spain, 28029
Pfizer Investigational Site
Madrid, Spain, 28006
Pfizer Investigational Site
Madrid, Spain, 28034
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Malaga, Spain, 29600
Pfizer Investigational Site
Malaga, Spain, 29010
Pfizer Investigational Site
Sevilla, Spain, 41071
Pfizer Investigational Site
Sevilla, Spain, 41013
Pfizer Investigational Site
Sevilla, Spain, 41014
Pfizer Investigational Site
Valencia, Spain, 46015
Pfizer Investigational Site
Valencia, Spain, 46010
Pfizer Investigational Site
Valencia, Spain, 46014
Pfizer Investigational Site
Valencia, Spain, 46009
Switzerland
Pfizer Investigational Site
Zürich, Switzerland, 8091
Taiwan
Pfizer Investigational Site
Kaohsiung County, Taiwan, 824
United Kingdom
Pfizer Investigational Site
Brighton, Sussex, United Kingdom, BN2 1ES
Pfizer Investigational Site
Crumpsall, Manchester, United Kingdom, M8 6RB
Pfizer Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Pfizer Investigational Site
London, United Kingdom, W2 1NY
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Pfizer Investigational Site
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00426660     History of Changes
Other Study ID Numbers: A4001050
Study First Received: January 22, 2007
Results First Received: June 2, 2011
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV Infections

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014