Effectiveness of Raltegravir-Based Antiretroviral Therapy in HIV-HCV Coinfected Liver Transplant Recipients (RAL-LT-HIV)
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ClinicalTrials.gov Identifier: NCT02995824
Recruitment Status : Unknown
Verified December 2016 by Jose M. Miro, Hospital Clinic of Barcelona. Recruitment status was: Active, not recruiting
This is a retrospective observational multicenter cohort study based on 271 consecutive HIV-HCV coinfected patients who underwent liver transplantation (LT) between 2002 and 2012 in 23 centers from Spain and who were prospectively followed until January 2016. The main objective of this study is to analyze the effectiveness and safety of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus Raltegravir (RAL)- based antiretroviral therapy (ART) compared to other antiretroviral regimens in liver transplant (LT) HIV-HCV co-infected recipients. In addition, the investigators want to know the rejection rates in patients taking RAL-based ART in comparison with other ART-regimens and to know the efficacy and safety of direct antiviral agents (DAAs) against HCV in HIV-infected liver transplant recipients taking RAL-based ART.
To analyze retrospectively the efficacy and safety of raltegravir plus 2 nucleoside reverse transcriptase inhibitors (NRTI) [lamivudine (3TC) or emtricitabine.(FTC) plus abacavir (ABC) or tenofovir (TDF)] [Group 1] versus other ART regimens including boosted PI or NNRTIs [Group 2] in 271 HIV/HCV-coinfected patients who underwent liver transplantation between 2002 and 2012 and were followed until December 2016.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Multicenter cohort study based on 271 consecutive HIV-HCV coinfected patients who underwent LT between 2002 and 2012 in 23 centers from Spain who were prospectively followed until January 2016. The study started at 2006 and, for patients who underwent LT between 2002 and 2005, the information was gathered retrospectively and they were followed until January 2016. HIV-HCV coinfected LT recipients were treated after LT, with RAL plus 2 nucleoside reverse transcriptase inhibitors (NRTI) [lamivudine (3TC) or emtricitabine.(FTC) plus abacavir (ABC) or tenofovir (TDF)] [Group 1] or other ART regimens including boosted PI or NNRTIs [Group 2].
HIV-infected patients who underwent liver transplantation between 2002 and 2012 in 23 centers from Spain who were prospectively followed until January 2016
Miro JM, et al. Combination of Raltegravir (RAL) plus Lamivudine (3TC) or Emtricitabine (FTC) plus Abacavir (ABV) or Tenofovir (TDF) is Safe, Effective and Prevents Pharmacokinetic (PK) Interactions with Immunosuppressive Drugs (IS) in HIV-1-infected Solid Organ Transplant (SOT) Recipients. 18th Conference on Retroviruses and Opportunistic Infections (CROI). Boston, MA. February 27- March 2, 2011. Abstract #644
Manzardo C, et al. Raltegravir (RAL) Based Antiretroviral Therapy (ART) in HIV-infected Solid Organ Transplant (SOT) Recipients: a Single Center Experience. 15th EACS Conference. Barcelona, Spain. October 21- 24 2015. Abstract #PE8/68.
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Jose M. Miro, Senior Consultant, Infectious Diseases, Hospital Clinic of Barcelona