Prospective Observational Epidemiologic Study of Maraviroc's Safety
NCT00665561
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Treatment experienced, HIV-1 infected patients
- 18 years or older
- Receive an approved assay for determination of HIV-1 tropism
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc
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Descriptive Information | |||||
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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 |
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Study Groups/Cohorts |
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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 | 2455 | ||||
Original Estimated Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | ViiV Healthcare | ||||
Study Sponsor | ViiV Healthcare | ||||
Collaborators | Pfizer | ||||
Investigators |
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PRS Account | ViiV Healthcare | ||||
Verification Date | March 2020 |