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

January 18, 2012 updated by: ViiV Healthcare

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Pfizer Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-030
        • Pfizer Investigational Site
  • United States
    • Florida
      • Clearwater, Florida, United States, 33765
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32803
        • Pfizer Investigational Site
      • Safety Harbor, Florida, United States, 34695
        • Pfizer Investigational Site
      • Wilton Manors, Florida, United States, 33305
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30312
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Pfizer Investigational Site
    • New York
      • Mt. Vernon, New York, United States, 10550
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Pfizer Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Pfizer Investigational Site
      • Conroe, Texas, United States, 77301
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390
        • Pfizer Investigational Site
      • Stafford, Texas, United States, 77477
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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 Criteria:

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Maraviroc
Drug: maraviroc
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.
Other Names:
  • Selzentry
Active Comparator: Etravirine
Drug: etravirine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 48 weeks
48 weeks
Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L.
Time Frame: 96 weeks
96 weeks
Percentage of subjects with Hy's law abnormalities through Week 48.
Time Frame: 48 weeks
48 weeks
Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.
Time Frame: 96 weeks
96 weeks
Change from baseline in mean Hepatitis C viral load through Week 48
Time Frame: 48 weeks
48 weeks
Undetectable HCV viral load 24 weeks after stopping HCV treatment.
Time Frame: 240 weeks
240 weeks
Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48.
Time Frame: 48 weeks
48 weeks
Change from baseline in CD4+ cell count at Week 48.
Time Frame: 48 weeks
48 weeks
Change from baseline in mean hepatitis B DNA through Week 48
Time Frame: 48 Weeks
48 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4001080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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