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WITHDRAWNPHASE4

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

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

NCT00782301•ViiV Healthcare

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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).

Locations (18)

Pfizer Investigational Site

Clearwater, Florida, United States

Pfizer Investigational Site

Orlando, Florida, United States

Pfizer Investigational Site

Safety Harbor, Florida, United States

Pfizer Investigational Site

Wilton Manors, Florida, United States

Pfizer Investigational Site

Atlanta, Georgia, United States

Pfizer Investigational Site

Atlanta, Georgia, United States

Pfizer Investigational Site

New Orleans, Louisiana, United States

Pfizer Investigational Site

Worcester, Massachusetts, United States

Pfizer Investigational Site

Worcester, Massachusetts, United States

Pfizer Investigational Site

Mount Vernon, New York, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

February 1, 2010

Completion Date

February 1, 2010

Last Updated

January 19, 2012

Conditions

Hepatitis BHuman Immunodeficiency VirusHepatitis C, Chronic

Interventions

maraviroc

DRUG

etravirine

DRUG

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RECRUITINGPHASE1

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

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Hepatitis B Virus Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Guaranteed Income to Boost HIV Care Continuity and Suppression Post-Jail Release

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Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

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