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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00864474
First received: March 17, 2009
Last updated: August 26, 2014
Last verified: August 2014

March 17, 2009
August 26, 2014
October 2010
March 2019   (final data collection date for primary outcome measure)
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 9 years (MAX) ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 9 years (MAX) ] [ Designated as safety issue: Yes ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 9 years (MAX) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00864474 on ClinicalTrials.gov Archive Site
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Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
Drug Use Investigation For HIV Infection Patients Of Maraviroc (Regulatory Post Marketing Commitment Plan)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Probability Sample

The patients whom an investigator involving A4001093 prescribes the Maraviroc Tablets (CELSENTRI® Tablets).

CCR5-tropic HIV-1 Infection
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
Maraviroc Tablets
Patients administered.
Intervention: Drug: CELSENTRI® Tablets
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
March 2019
March 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered CELSENTRI® Tablets.

Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00864474
A4001093
No
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP