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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00782301
• Other study ID #: A4001080
• Status: Withdrawn
• Phase: Phase 4
• First received: October 29, 2008
• Last updated: January 18, 2012
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: January 2012
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Hepatitis C, Chronic
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• maraviroc
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.
• etravirine
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.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Poland	Pfizer Investigational Site	Bydgoszcz
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Bellaire	Texas
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Conroe	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Mt. Vernon	New York
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Safety Harbor	Florida
United States	Pfizer Investigational Site	Stafford	Texas
United States	Pfizer Investigational Site	Tulsa	Oklahoma
United States	Pfizer Investigational Site	Wilton Manors	Florida
United States	Pfizer Investigational Site	Worcester	Massachusetts
United States	Pfizer Investigational Site	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT =100 IU/L.		96 weeks	Yes
Secondary	Percentage of subjects with Hy's law abnormalities through Week 48.		48 weeks	Yes
Secondary	Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.		96 weeks	Yes
Secondary	Change from baseline in mean Hepatitis C viral load through Week 48		48 weeks	No
Secondary	Undetectable HCV viral load 24 weeks after stopping HCV treatment.		240 weeks	No
Secondary	Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48.		48 weeks	No
Secondary	Change from baseline in CD4+ cell count at Week 48.		48 weeks	No
Secondary	Change from baseline in mean hepatitis B DNA through Week 48		48 Weeks	No

External Links

•   To obtain contact information for a study center near you, click here.