Status:
WITHDRAWN
Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
Hepatitis B
Human Immunodeficiency Virus
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00782301
Start Date
March 1 2009
End Date
February 1 2010
Last Update
January 19 2012
Active Locations (18)
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1
Pfizer Investigational Site
Clearwater, Florida, United States, 33765
2
Pfizer Investigational Site
Orlando, Florida, United States, 32803
3
Pfizer Investigational Site
Safety Harbor, Florida, United States, 34695
4
Pfizer Investigational Site
Wilton Manors, Florida, United States, 33305