Overview

This trial is active, not recruiting.

Condition ccr5-tropic hiv-1 infection
Treatment celsentri® tablets
Sponsor ViiV Healthcare
Collaborator Pfizer
Start date March 2010
End date March 2019
Trial size 50 participants
Trial identifier NCT00864474, A4001093

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
Patients administered.
celsentri® tablets CELSENTRI® Tablets, maraviroc, Selzentry
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".

Primary Outcomes

Measure
The incidence of adverse drug reactions in this surveillance.
time frame: 9 years (MAX)
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).
time frame: 9 years (MAX)
Factors considered to affect the safety and/or efficacy of this drug.
time frame: 9 years (MAX)

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered CELSENTRI® Tablets.

Additional Information

Official title Drug Use Investigation For Hiv Infection Patients Of Maraviroc (Regulatory Post Marketing Commitment Plan).
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by ViiV Healthcare.