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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00782301
First received: October 29, 2008
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Hepatitis B
Human Immunodeficiency Virus
Hepatitis C, Chronic
Drug: maraviroc
Drug: etravirine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with Hy's law abnormalities through Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of HCV treated subjects with Hy's law abnormalities through Week 96. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in mean Hepatitis C viral load through Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Undetectable HCV viral load 24 weeks after stopping HCV treatment. [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count at Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean hepatitis B DNA through Week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782301

Locations
United States, Florida
Pfizer Investigational Site
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
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30312
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01655
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01605
United States, New York
Pfizer Investigational Site
Mt. Vernon, New York, United States, 10550
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Texas
Pfizer Investigational Site
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
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-030
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00782301     History of Changes
Other Study ID Numbers: A4001080
Study First Received: October 29, 2008
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV and Hepatitis co-infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis C, Chronic
Immunologic Deficiency Syndromes
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Flaviviridae Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Immune System Diseases
Lentivirus Infections
Liver Diseases
Picornaviridae Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Etravirine
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014