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A4001067

Study ID: A4001067

Sponsor: Pfizer

Title: An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients (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.

Phase #: 4

Study Design: Observational Cohort Prospective

Eligibility Criteria:

• 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

Drugs/Treatment Provided:

Groups/Cohorts: Maraviroc exposed Drug: Maraviroc along with an optimized background antiretroviral drug regimen Maraviroc prescribed per approved local label.

Groups/Cohorts: Maraviroc Drug: Optimized background antiretroviral drug regimen without maraviroc v

Duration: Up to 5 years

Compensation to Participant: To be determined

Principal Investigator: Donna Mildvan, MD

Study Location:
Beth Israel Medical Center
AIDS Clinical Trials Unit
350 East 17th Street, 3rd Floor
New York, NY 10003

Contact Information:
Ph: 212-420-4519 or 800-483-7339

Email: Trials@BethIsraelNY-HIVtrials.org

ALL TRIALS IN THIS CATEGORY

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Pfizer A4001067

An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients (POEM)

GSK SAILING ING111762

NOW OPEN. A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-NaÔve, Antiretroviral Therapy-Experienced Adults

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