Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Raltegravir-Based Antiretroviral Therapy in HIV-HCV Coinfected Liver Transplant Recipients (RAL-LT-HIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02995824
Recruitment Status : Unknown
Verified December 2016 by Jose M. Miro, Hospital Clinic of Barcelona.
Recruitment status was:  Active, not recruiting
First Posted : December 16, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Jose M. Miro, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment
Liver Transplantation HIV Infections Antiretroviral Therapy Other: Raltegravir-based antiretroviral therapy

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 271 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness of Raltegravir-Based Antiretroviral Therapy in HIV-HCV Coinfected Liver Transplant Recipients: Retrospective Analysis in a Prospective National Cohort Study (RAL-LT-HIV)
Study Start Date : January 2002
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Raltegravir-based antiretroviral therapy
    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.


Primary Outcome Measures :
  1. Incidence of plasma RNA HIV viral rebound in plasma after liver transplantation [ Time Frame: Through study completion, an average of 3 years ]
    Plasma HIV viral load above 50 copies/mL


Secondary Outcome Measures :
  1. CD4+ T cell evolution after liver transplantation [ Time Frame: Through study completion, an average of 3 years ]
    CD4+ T cell count below 100 cells/mm3

  2. Incidence of acute rejection after liver transplantation [ Time Frame: Up to 24 weeks ]
    Biopsy-proven acute rejection (yes or not)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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].
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995824


Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Layout table for investigator information
Principal Investigator: Jose M Miro, MD PhD Hospital Clinic, Barcelona, Spain

Publications:
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.

Layout table for additonal information
Responsible Party: Jose M. Miro, Senior Consultant, Infectious Diseases, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02995824     History of Changes
Other Study ID Numbers: 2008-4248
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jose M. Miro, Hospital Clinic of Barcelona:
Liver transplantation
HIV infection
Antiretroviral therapy
Raltegravir

Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Anti-HIV Agents
HIV Integrase Inhibitors
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Immune System Diseases
Anti-Retroviral Agents
Raltegravir Potassium
Antiviral Agents
Anti-Infective Agents
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action