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: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
CCR5-tropic HIV-1 Infection
Drug: CELSENTRI® Tablets
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Drug Use Investigation For HIV Infection Patients Of Maraviroc (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864474

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

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00864474     History of Changes
Other Study ID Numbers: A4001093
Study First Received: March 17, 2009
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 31, 2014