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Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00864474
Recruitment Status : Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : November 22, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition or disease Intervention/treatment
CCR5-tropic HIV-1 Infection Drug: CELSENTRI® Tablets

Detailed Description:
All the patients whom an investigator prescribes the first CELSENTRI® Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Drug Use Investigation For Hiv Infection Patients Of Maraviroc (Regulatory Post Marketing Commitment Plan).
Actual Study Start Date : March 31, 2010
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Maraviroc Tablets
Patients administered.
Drug: CELSENTRI® Tablets
CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food".
Other Name: CELSENTRI® Tablets, maraviroc, Selzentry

Outcome Measures

Primary Outcome Measures :
  1. The incidence of adverse drug reactions in this surveillance. [ Time Frame: 9 years (MAX) ]
  2. Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 9 years (MAX) ]
  3. Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 9 years (MAX) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving A4001093 prescribes the Maraviroc Tablets (CELSENTRI® Tablets).

Inclusion Criteria:

Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered CELSENTRI® Tablets.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864474

Sponsors and Collaborators
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00864474     History of Changes
Other Study ID Numbers: A4001093
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents