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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00782301

Purpose

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

Condition	Intervention	Phase
Hepatitis B Human Immunodeficiency Virus Hepatitis C, Chronic	Drug: maraviroc Drug: etravirine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Hepatitis Hepatitis B Hepatitis C

Drug Information available for: Ritonavir Darunavir Etravirine Maraviroc Raltegravir

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Maraviroc: Active Comparator	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: Active Comparator	Drug: 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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782301

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 38 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4001080
Study First Received:	October 29, 2008
Last Updated:	November 13, 2009
ClinicalTrials.gov Identifier:	NCT00782301 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

HIV and Hepatitis co-infection

Additional relevant MeSH terms:

Hepatitis C, Chronic
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
Hepatitis
Hepatitis, Chronic
Liver Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Flaviviridae Infections

Immune System Diseases
Acquired Immunodeficiency Syndrome
Hepadnaviridae Infections
Immunologic Deficiency Syndromes
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 20, 2009