Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)

ViiV Healthcare

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Maraviroc along with an optimized background antiretroviral drug regimen; Drug: Optimized background antiretroviral drug regimen without maraviroc

Study type: Observational

Funder types: Industry

Identifiers

NCT00665561

2007-006148-24 (EudraCT Number)

A4001067

POEM (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 2,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment experienced, HIV-1 infected patients
• 18 years or older
• Receive an approved assay for determination of HIV-1 tropism

Exclusion criteria

• Pregnant or lactating
• Using CCR5 inhibitor other than maraviroc

Trial design

2,500 participants in 2 patient groups

Maraviroc exposed

Treatment:

Drug: Maraviroc along with an optimized background antiretroviral drug regimen

Maraviroc unexposed

Treatment:

Drug: Optimized background antiretroviral drug regimen without maraviroc