NCT00665561

Prospective Observational Epidemiologic Study of Maraviroc's Safety

AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

Detailed description

All patients meeting the study eligibility criteria at participating sites will be invited to participate.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Maraviroc along with an optimized background antiretroviral drug regimen	Maraviroc prescribed per approved local label.
DRUG	Optimized background antiretroviral drug regimen without maraviroc	Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Timeline

• Start date: 2008-03-31
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2008-04-24
• Last updated: 2022-10-18
• Results posted: 2020-04-07

Locations

269 sites across 11 countries: United States, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Puerto Rico, Spain, United Kingdom

Regulatory

• FDA-regulated drug study