Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
A Multicenter, Randomized, Open, Comparative Trial Of Maraviroc Versus Etravirine Each In Combination With Darunavir/Ritonavir And Raltegravir For The Treatment Of Antiretroviral-Experienced HIV-1 Subjects Co-Infected With Hepatitis C And/Or Hepatitis B
1 other identifier
interventional
N/A
3 countries
18
Brief Summary
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2009
Shorter than P25 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJanuary 19, 2012
January 1, 2012
11 months
October 29, 2008
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through Week 48.
48 weeks
Secondary Outcomes (9)
Percentage of HCV treated subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through 96.
48 weeks
Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L.
96 weeks
Percentage of subjects with Hy's law abnormalities through Week 48.
48 weeks
Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.
96 weeks
Change from baseline in mean Hepatitis C viral load through Week 48
48 weeks
- +4 more secondary outcomes
Study Arms (2)
Maraviroc
ACTIVE COMPARATOREtravirine
ACTIVE COMPARATORInterventions
maraviroc 150 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
etravirine 200 mg. p.o. b.i.d., darunavir 600 mg. p.o. b.i.d., ritonavir 100 mg. p.o. b.i.d., raltegravir 400 mg. p.o. b.i.d.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- Pfizercollaborator
Study Sites (18)
Pfizer Investigational Site
Clearwater, Florida, 33765, United States
Pfizer Investigational Site
Orlando, Florida, 32803, United States
Pfizer Investigational Site
Safety Harbor, Florida, 34695, United States
Pfizer Investigational Site
Wilton Manors, Florida, 33305, United States
Pfizer Investigational Site
Atlanta, Georgia, 30308, United States
Pfizer Investigational Site
Atlanta, Georgia, 30312, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70112, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01605, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01655, United States
Pfizer Investigational Site
Mount Vernon, New York, 10550, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74135, United States
Pfizer Investigational Site
Bellaire, Texas, 77401, United States
Pfizer Investigational Site
Conroe, Texas, 77301, United States
Pfizer Investigational Site
Dallas, Texas, 75390, United States
Pfizer Investigational Site
Stafford, Texas, 77477, United States
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2C7, Canada
Pfizer Investigational Site
Toronto, Ontario, M5G 2N2, Canada
Pfizer Investigational Site
Bydgoszcz, 85-030, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
March 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
January 19, 2012
Record last verified: 2012-01