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This study has been withdrawn prior to enrollment.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

October 29, 2008
January 18, 2012
March 2009
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00782301 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis B
  • Human Immunodeficiency Virus
  • Hepatitis C, Chronic
  • 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.
  • Active Comparator: Maraviroc
    Intervention: Drug: maraviroc
  • Active Comparator: Etravirine
    Intervention: Drug: etravirine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2010
February 2010   (final data collection date for primary outcome measure)

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).

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Poland
 
NCT00782301
A4001080
No
ViiV Healthcare
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
January 2012

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