Prospective Observational Epidemiologic Study of Maraviroc's Safety

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NCT00665561

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Study Location
Health Services Center
Hobson City, Alabama, 36201, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Immunodeficiency Virus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Treatment experienced, HIV-1 infected patients

- 18 years or older

- Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnant or lactating


- Using CCR5 inhibitor other than maraviroc

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  2. Orange, California
  3. Wilmington, Delaware
  4. Washington, District of Columbia
  5. Jacksonville, Florida
  6. Miami, Florida
  7. Tampa, Florida
  8. Atlanta, Georgia
  9. Atlanta, Georgia
  10. Jackson, Mississippi
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  13. Cincinnati, Ohio
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  16. Houston, Texas
  17. Richmond, Virginia
  18. Richmond, Virginia
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  23. Roma,
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  1. Hobson City, Alabama
  2. Huntsville, Alabama
  3. Huntsville, Alabama
  4. Bakersfield, California
  5. Burbank, California
  6. Fountain Valley, California
  7. Long Beach, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Oakland, California
  12. Orange, California
  13. Palm Desert, California
  14. Palo Alto, California
  15. Sacramento, California
  16. San Francisco, California
  17. San Francisco, California
  18. Stanford, California
  19. Victorville, California
  20. Denver, Colorado
  21. Denver, Colorado
  22. Lafayette, Colorado
  23. New Haven, Connecticut
  24. New Haven, Connecticut
  25. New Haven, Connecticut
  26. Norwalk, Connecticut
  27. Washington, District of Columbia
  28. Washington, District of Columbia
  29. Washington, District of Columbia
  30. Washington, District of Columbia
  31. Washington, District of Columbia
  32. Boynton Beach, Florida
  33. Daytona Beach, Florida
  34. Fort Myers, Florida
  35. Fort Pierce, Florida
  36. Jacksonville, Florida
  37. Miami Beach, Florida
  38. Miami, Florida
  39. Miami, Florida
  40. Miami, Florida
  41. Safety Harbor, Florida
  42. Saint Petersburg, Florida
  43. Tampa, Florida
  44. Tampa, Florida
  45. Tampa, Florida
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  47. Wilton Manors, Florida
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  50. Atlanta, Georgia
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  56. Marietta, Georgia
  57. Marietta, Georgia
  58. Riverdale, Georgia
  59. Savannah, Georgia
  60. Chicago, Illinois
  61. Chicago, Illinois
  62. Chicago, Illinois
  63. Olympia Fields, Illinois
  64. Olympia Fields, Illinois
  65. Springfield, Illinois
  66. Iowa City, Iowa
  67. Lexington, Kentucky
  68. Lexington, Kentucky
  69. Lexington, Kentucky
  70. New Orleans, Louisiana
  71. New Orleans, Louisiana
  72. Silver Spring, Maryland
  73. Brighton, Massachusetts
  74. Springfield, Massachusetts
  75. Springfield, Massachusetts
  76. Ann Arbor, Michigan
  77. Detroit, Michigan
  78. Grosse Pointe Woods, Michigan
  79. Lansing, Michigan
  80. Lansing, Michigan
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  85. Saint Louis, Missouri
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  87. Neptune, New Jersey
  88. Neptune, New Jersey
  89. Newark, New Jersey
  90. Buffalo, New York
  91. Ithaca, New York
  92. Manhasset, New York
  93. New York, New York
  94. New York, New York
  95. New York, New York
  96. New York, New York
  97. New York, New York
  98. New York, New York
  99. New York, New York
  100. Rochester, New York
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  102. Valhalla, New York
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  104. Greenville, North Carolina
  105. Huntersville, North Carolina
  106. Winston-Salem, North Carolina
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  108. Columbus, Ohio
  109. Toledo, Ohio
  110. Oklahoma City, Oklahoma
  111. Portland, Oregon
  112. Portland, Oregon
  113. Allentown, Pennsylvania
  114. Harrisburg, Pennsylvania
  115. Philadelphia, Pennsylvania
  116. Philadelphia, Pennsylvania
  117. Philadelphia, Pennsylvania
  118. Sayre, Pennsylvania
  119. Charleston, South Carolina
  120. Charleston, South Carolina
  121. Columbia, South Carolina
  122. Columbia, South Carolina
  123. Columbia, South Carolina
  124. Austin, Texas
  125. Bellaire, Texas
  126. Dallas, Texas
  127. Dallas, Texas
  128. Dallas, Texas
  129. Dallas, Texas
  130. Fort Worth, Texas
  131. Fort Worth, Texas
  132. Fort Worth, Texas
  133. Harlingen, Texas
  134. Harlingen, Texas
  135. Houston, Texas
  136. Houston, Texas
  137. Plano, Texas
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  139. San Antonio, Texas
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  141. Lynchburg, Virginia
  142. Seattle, Washington
  143. Huntington, West Virginia
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  146. Brussels,
  147. Leuven,
  148. Liege,
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  150. Curitiba, Parana
  151. Nova Iguacu, RJ
  152. Santo André, SP
  153. Sao Paulo, SP
  154. São Paulo, SP
  155. Vancouver, British Columbia
  156. Halifax, Nova Scotia
  157. Toronto, Ontario
  158. Toronto, Ontario
  159. Montreal, Quebec
  160. Montreal, Quebec
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  169. Paris,
  170. Paris,
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  174. PESSAC Cedex,
  175. Rennes,
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  177. Aachen,
  178. Berlin,
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  184. Hamburg,
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Advanced Information
Descriptive Information
Brief Title Prospective Observational Epidemiologic Study of Maraviroc's Safety
Official Title AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS
Brief Summary The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
Detailed Description All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Treatment experienced, HIV-1 infected patients in routine clinical practice.
Condition Human Immunodeficiency Virus
Intervention
  • Drug: Maraviroc along with an optimized background antiretroviral drug regimen
    Maraviroc prescribed per approved local label.
    Other Name: Selzentry, Celsentri
  • Drug: Optimized background antiretroviral drug regimen without maraviroc
    Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
Study Groups/Cohorts
  • Maraviroc exposed
    Intervention: Drug: Maraviroc along with an optimized background antiretroviral drug regimen
  • Maraviroc unexposed
    Intervention: Drug: Optimized background antiretroviral drug regimen without maraviroc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2019)		2455
Original Estimated Enrollment
 (submitted: April 23, 2008)		3000
Actual Study Completion Date February 14, 2019
Actual Primary Completion Date February 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Treatment experienced, HIV-1 infected patients
  • 18 years or older
  • Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:

  • Pregnant or lactating
  • Using CCR5 inhibitor other than maraviroc
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Brazil,   Canada,   France,   Germany,   Greece,   Italy,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries Portugal
 
Administrative Information
NCT Number NCT00665561
Other Study ID Numbers A4001067
2007-006148-24 ( EudraCT Number )
POEM ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party ViiV Healthcare
Study Sponsor ViiV Healthcare
Collaborators Pfizer
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date March 2020