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

NCT02995824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 271

Last updated 2020-02-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Jose M Miro, MD PhD · Hospital Clinic, Barcelona, Spain

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02995824 on ClinicalTrials.gov