Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients

Withdrawn before enrolling · Phase 4

Conditions studied: Hepatitis B, Human Immunodeficiency Virus, Hepatitis C, Chronic

In brief

Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.

Key facts

Study ID

NCT00782301

Run by

ViiV Healthcare

People needed

0

Starts

2009-03-01

Expected to finish

2010-02-01

Last updated by the study team

2012-01-19

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 RNA viral load of ≥1000 copies/mL at the screening visit. Detectable HCV RNA levels or Hepatitis B surface antigen (HBsAg) positive. Previous antiretroviral treatment experience with at least 2 antiretroviral drug classes for ≥3 months.
• Documented resistance to an NNRTI as well as documented resistance to another antiretroviral agent.
• CCR5 tropic virus detected by the TrofileTM assay.

You may not qualify if…

• Suspected or documented active, untreated HIV-1 related Opportunistic Infection (OI) or other condition requiring acute therapy at the time of randomization (subjects on a stable (>1 month) secondary OI prophylaxis regimen are eligible for the study; subjects on a primary OI prophylaxis regimen of any duration are also eligible for the study).
• Prior treatment with darunavir/ritonavir, raltegravir, or another integrase inhibitor, etravirine, maraviroc or another CCR5 inhibitor for more than 14 days at any time.
• Subjects receiving treatment for chronic Hepatitis or the expected need to initiate HCV treatment within 48 weeks of randomization. (Subjects who were previously treated for Hepatitis C are eligible for the study).
• AST and/or ALT greater than 5 times the upper limit of normal (ACTG Grade 3).

Where it is running

• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Safety Harbor, Florida, United States
• Pfizer Investigational Site — Wilton Manors, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Worcester, Massachusetts, United States
• Pfizer Investigational Site — Worcester, Massachusetts, United States
• Pfizer Investigational Site — Mount Vernon, New York, United States
• Pfizer Investigational Site — Tulsa, Oklahoma, United States
• Pfizer Investigational Site — Bellaire, Texas, United States
• Pfizer Investigational Site — Conroe, Texas, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Stafford, Texas, United States
• Pfizer Investigational Site — Vancouver, British Columbia, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Bydgoszcz, Poland

Full record on ClinicalTrials.gov

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