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

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

Official Title
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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

Conditions
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Hepatitis B, Human Immunodeficiency Virus, Hepatitis C, Chronic

Intervention / Treatment
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* Drug: maraviroc
* Drug: etravirine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Maraviroc<br> | Drug: maraviroc<br>* 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.<br>* Other names: Selzentry;|
| Active Comparator: Etravirine<br> | Drug: etravirine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV and Hepatitis co-infection