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

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ClinicalTrials.gov Identifier: NCT00782301
Recruitment Status : Withdrawn
First Posted : October 31, 2008
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Tracking Information
First Submitted Date  ICMJE October 29, 2008
First Posted Date  ICMJE October 31, 2008
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE March 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2010)
  • 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 ]
  • 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 ]
  • Percentage of subjects with Hy's law abnormalities through Week 48. [ Time Frame: 48 weeks ]
  • Percentage of HCV treated subjects with Hy's law abnormalities through Week 96. [ Time Frame: 96 weeks ]
  • Change from baseline in mean Hepatitis C viral load through Week 48 [ Time Frame: 48 weeks ]
  • Undetectable HCV viral load 24 weeks after stopping HCV treatment. [ Time Frame: 240 weeks ]
  • Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48. [ Time Frame: 48 weeks ]
  • Change from baseline in CD4+ cell count at Week 48. [ Time Frame: 48 weeks ]
  • Change from baseline in mean hepatitis B DNA through Week 48 [ Time Frame: 48 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2008)
  • 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 ]
  • 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 ]
  • Percentage of subjects with Hy's law abnormalities through Week 48. [ Time Frame: 48 weeks ]
  • Percentage of HCV treated subjects with Hy's law abnormalities through Week 96. [ Time Frame: 96 weeks ]
  • Change from baseline in mean Hepatitis C viral load through Week 48 [ Time Frame: 48 weeks ]
  • Undetectable HCV viral load 24 weeks after stopping HCV treatment. [ Time Frame: 240 weeks ]
  • Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48. [ Time Frame: 48 weeks ]
  • Change from baseline in CD4+ cell count at Week 48. [ Time Frame: 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
Official Title  ICMJE 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
Brief Summary Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis B
  • Human Immunodeficiency Virus
  • Hepatitis C, Chronic
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: Maraviroc
    Intervention: Drug: maraviroc
  • Active Comparator: Etravirine
    Intervention: Drug: etravirine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 6, 2011)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2008)
120
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00782301
Other Study ID Numbers  ICMJE A4001080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ViiV Healthcare
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account ViiV Healthcare
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP