Effectiveness of Raltegravir-Based Antiretroviral Therapy in HIV-HCV Coinfected Liver Transplant Recipients

NCT02995824 | Completed

• 1 other identifier: 2008-4248
• Study Type: observational
• Target: 271
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Transplantation; HIV Infections; Antiretroviral Therapy

Keywords

Liver transplantation; HIV infection; Antiretroviral therapy; Raltegravir

Outcome Measures

Primary Outcomes (1)

• Incidence of plasma RNA HIV viral rebound in plasma after liver transplantation

  Plasma HIV viral load above 50 copies/mL

  Through study completion, an average of 3 years

Secondary Outcomes (2)

• CD4+ T cell evolution after liver transplantation

  Through study completion, an average of 3 years

• Incidence of acute rejection after liver transplantation

  Up to 24 weeks

Interventions

Raltegravir-based antiretroviral therapy OTHER

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 \[Group 2\].

You may qualify if:

• HIV-infected patients who underwent liver transplantation between 2002 and 2012 in 23 centers from Spain who were prospectively followed until January 2016

You may not qualify if:

• None

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Related Publications (10)

• Roland ME, Barin B, Huprikar S, Murphy B, Hanto DW, Blumberg E, Olthoff K, Simon D, Hardy WD, Beatty G, Stock PG; HIVTR Study Team. Survival in HIV-positive transplant recipients compared with transplant candidates and with HIV-negative controls. AIDS. 2016 Jan 28;30(3):435-44. doi: 10.1097/QAD.0000000000000934.

  PMID: 26765937 BACKGROUND

• Terrault NA, Roland ME, Schiano T, Dove L, Wong MT, Poordad F, Ragni MV, Barin B, Simon D, Olthoff KM, Johnson L, Stosor V, Jayaweera D, Fung J, Sherman KE, Subramanian A, Millis JM, Slakey D, Berg CL, Carlson L, Ferrell L, Stablein DM, Odim J, Fox L, Stock PG; Solid Organ Transplantation in HIV: Multi-Site Study Investigators. Outcomes of liver transplant recipients with hepatitis C and human immunodeficiency virus coinfection. Liver Transpl. 2012 Jun;18(6):716-26. doi: 10.1002/lt.23411.

  PMID: 22328294 BACKGROUND

• Miro JM, Montejo M, Castells L, Rafecas A, Moreno S, Aguero F, Abradelo M, Miralles P, Torre-Cisneros J, Pedreira JD, Cordero E, de la Rosa G, Moyano B, Moreno A, Perez I, Rimola A; Spanish OLT in HIV-Infected Patients Working Group investigators. Outcome of HCV/HIV-coinfected liver transplant recipients: a prospective and multicenter cohort study. Am J Transplant. 2012 Jul;12(7):1866-76. doi: 10.1111/j.1600-6143.2012.04028.x. Epub 2012 Apr 4.

  PMID: 22471341 BACKGROUND

• van Maarseveen EM, Rogers CC, Trofe-Clark J, van Zuilen AD, Mudrikova T. Drug-drug interactions between antiretroviral and immunosuppressive agents in HIV-infected patients after solid organ transplantation: a review. AIDS Patient Care STDS. 2012 Oct;26(10):568-81. doi: 10.1089/apc.2012.0169.

  PMID: 23025916 BACKGROUND

• Powderly WG. Integrase inhibitors in the treatment of HIV-1 infection. J Antimicrob Chemother. 2010 Dec;65(12):2485-8. doi: 10.1093/jac/dkq350. Epub 2010 Sep 18.

  PMID: 20852268 BACKGROUND

• Kassahun K, McIntosh I, Cui D, Hreniuk D, Merschman S, Lasseter K, Azrolan N, Iwamoto M, Wagner JA, Wenning LA. Metabolism and disposition in humans of raltegravir (MK-0518), an anti-AIDS drug targeting the human immunodeficiency virus 1 integrase enzyme. Drug Metab Dispos. 2007 Sep;35(9):1657-63. doi: 10.1124/dmd.107.016196. Epub 2007 Jun 25.

  PMID: 17591678 BACKGROUND

• Brainard DM, Wenning LA, Stone JA, Wagner JA, Iwamoto M. Clinical pharmacology profile of raltegravir, an HIV-1 integrase strand transfer inhibitor. J Clin Pharmacol. 2011 Oct;51(10):1376-402. doi: 10.1177/0091270010387428. Epub 2011 Jan 5.

  PMID: 21209233 BACKGROUND

• Tricot L, Teicher E, Peytavin G, Zucman D, Conti F, Calmus Y, Barrou B, Duvivier C, Fontaine C, Welker Y, Billy C, de Truchis P, Delahousse M, Vittecoq D, Salmon-Ceron D. Safety and efficacy of raltegravir in HIV-infected transplant patients cotreated with immunosuppressive drugs. Am J Transplant. 2009 Aug;9(8):1946-52. doi: 10.1111/j.1600-6143.2009.02684.x. Epub 2009 Jun 10.

  PMID: 19519819 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jose M Miro, MD PhD

  Hospital Clinic, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Infectious Diseases

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 16, 2016
• Study Start: January 1, 2002
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share