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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00782301

Enrollment

Registered

2008-10-31

Start date

2009-03-31

Completion date

2010-02-28

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Hepatitis C, Chronic, Human Immunodeficiency Virus

Keywords

HIV and Hepatitis co-infection

Brief summary

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

Interventions

DRUGmaraviroc

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.

DRUGetravirine

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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.	48 weeks

Secondary

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

Countries

Canada, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026