Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients
NCT00782301
ABOUT THIS STUDY
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Adult Trials: 18+ Years
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.
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).
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Withdrawn | |||
| Actual Enrollment ICMJE | 0 | |||
| Original Estimated Enrollment ICMJE | 120 | |||
| Actual Study Completion Date ICMJE | February 2010 | |||
| Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | 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). | |||
| Sex/Gender ICMJE |
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| Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, Poland, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00782301 | |||
| Other Study ID Numbers ICMJE | A4001080 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | ViiV Healthcare | |||
| Study Sponsor ICMJE | ViiV Healthcare | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
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| PRS Account | ViiV Healthcare | |||
| Verification Date | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||