Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus
Treatments maraviroc along with an optimized background antiretroviral drug regimen, optimized background antiretroviral drug regimen without maraviroc
Sponsor ViiV Healthcare
Collaborator Pfizer
Start date March 2008
End date October 2018
Trial size 3000 participants
Trial identifier NCT00665561, 2007-006148-24, A4001067, POEM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
maraviroc along with an optimized background antiretroviral drug regimen Selzentry
Maraviroc prescribed per approved local label.
optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Primary Outcomes

Measure
CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths
time frame: Followed till 6 months after drug discontinuation up to a total of 5 years.
All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality
time frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion.

Secondary Outcomes

Measure
There are no Secondary Outcomes for this study.
time frame: 0

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients
Description All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by ViiV Healthcare.