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

Phase 4

Withdrawn

• Conditions: Hepatitis B; Human Immunodeficiency Virus; Hepatitis C, Chronic
• Interventions: Drug: etravirine; Drug: maraviroc

• Registration Number: NCT00782301
• Lead Sponsor: ViiV Healthcare

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 available

Study Timeline

• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Study Start: 2009-03
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etravirine	etravirine	-
Maraviroc	maraviroc	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Change from baseline in mean Hepatitis C viral load through Week 48	48 weeks
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇱 Bydgoszcz, Poland