Prospective Observational Epidemiologic Study of Maraviroc's Safety

NCT00665561

Last updated date
Study Location
Health Services Center
Hobson City, Alabama, 36201, United States
Contact
1-800-718-1021

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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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  16. Houston, Texas
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  18. Richmond, Virginia
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  20. São Paulo,
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  23. Roma,
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  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
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  26. Norwalk, Connecticut
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  28. Washington, District of Columbia
  29. Washington, District of Columbia
  30. Washington, District of Columbia
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  32. Boynton Beach, Florida
  33. Daytona Beach, Florida
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  61. Chicago, Illinois
  62. Chicago, Illinois
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  64. Olympia Fields, Illinois
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  66. Iowa City, Iowa
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  68. Lexington, Kentucky
  69. Lexington, Kentucky
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  71. New Orleans, Louisiana
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  97. New York, New York
  98. New York, New York
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  110. Oklahoma City, Oklahoma
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  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
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  129. Dallas, Texas
  130. Fort Worth, Texas
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  132. Fort Worth, Texas
  133. Harlingen, Texas
  134. Harlingen, Texas
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  136. Houston, Texas
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  154. São Paulo, SP
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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