NCT00864474

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).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• CCR5-tropic HIV-1 Infection

Interventions

Type	Name	Description
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".

Timeline

• Start date: 2010-03-31
• Primary completion: 2018-12-24
• Completion: 2018-12-24
• First posted: 2009-03-18
• Last updated: 2020-01-02
• Results posted: 2020-01-02

Regulatory

• FDA-regulated drug study