A Phase 4 interventional study of maraviroc and etravirine in Hepatitis B, Human Immunodeficiency Virus and Hepatitis C, Chronic, sponsored by ViiV Healthcare. Withdrawn at 18 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-01-19.
Sponsored by ViiV Healthcare · Phase 4, Interventional, and Treatment
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
Browse Hepatitis A studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Drug: maraviroc
Drug: etravirine
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.
Also known as: Selzentry
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.
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
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
This study is withdrawn, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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