Clinical trial NCT00782301: Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hepatitis B
Human Immunodeficiency Virus
Hepatitis C, Chronic
Keywords: HIV and Hepatitis co-infection
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-10-31
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
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.
timeFrame: 48 weeks
Secondary outcomes:
measure: 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.
timeFrame: 48 weeks
measure: Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L.
timeFrame: 96 weeks
measure: Percentage of subjects with Hy's law abnormalities through Week 48.
timeFrame: 48 weeks
measure: Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.
timeFrame: 96 weeks
measure: Change from baseline in mean Hepatitis C viral load through Week 48
timeFrame: 48 weeks
measure: Undetectable HCV viral load 24 weeks after stopping HCV treatment.
timeFrame: 240 weeks
measure: Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48.
timeFrame: 48 weeks
measure: Change from baseline in CD4+ cell count at Week 48.
timeFrame: 48 weeks
measure: Change from baseline in mean hepatitis B DNA through Week 48
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Safety Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Wilton Manors
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Mt. Vernon
country: United States
facility: Pfizer Investigational Site
state: New York
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Bellaire
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Conroe
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Stafford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: