Transplantation and the Use of Raltegravir in HIV-Infected Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Duke University
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01793467
First received: February 13, 2013
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

Raltegravir (RAL) is a preferred option for initial antiretroviral therapy in the most recent HIV Treatment Guidelines and is emerging as a popular choice for use in the specialized population of HIV-infected patients being considered for solid organ transplantation. Data from HIV-infected persons with normal organ function have revealed few raltegravir-associated metabolic complications compared to older antiretrovirals, and in general, drug-drug interactions with raltegravir are infrequent. The absence of such concerns appears to make raltegravir a potentially appealing option for antiretroviral therapy in HIV-infected patients being considered for solid organ transplantation.

At present, however, little is known of the safety and long term tolerability of RAL-containing regimens in persons undergoing solid organ transplantation. As more HIV-infected patients undergo organ transplantation, there is a growing need for good data on such things as the effect of dialysis on RAL concentrations, the potential interactions with commonly used immunosuppressive drugs, and the pharmacokinetic (PK) /pharmacodynamic (PD) characteristics in those with end stage organ failure, as well as those with functioning grafts.

The proposed study will also examine transplant function and survival in HIV-infected patients receiving RAL-containing ART and will compare it to HIV negative historic controls.


Condition
HIV Positive
Organ Transplant Recipient
Active Wait Listing for Organ Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Solid Organ Transplantation and the Use of Raltegravir in HIV-Infected Patients: An Observational Study of Pharmacokinetics, Safety, Tolerability and Efficacy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To examine raltegravir (RAL) in the management of HIV-infected persons listed for solid organ transplantation, with a focus on mortality and graft survival [ Time Frame: 3+ years ]

Secondary Outcome Measures:
  • Assess Raltegravir viability as a long term HIV treatment drug for patients undergoing transplant [ Time Frame: 3+ years ]
    1. Characterize the effect of raltegravir-based regimens on the pre and post-transplant endocrine and cardiovascular effects
    2. Evaluate drug-drug interactions between raltegravir and current transplant immunosuppressant regimens.
    3. Determine RAL pharmacokinetic (PK) profile in HIV-infected patients with end organ failure before and after organ transplantation.

    a) Measure RAL PK in HIV-infected patients with end-stage renal failure (ESRF), who are receiving dialysis pre-transplant.

    b) Assess raltegravir PK in patients with different severities of liver disease, including cirrhosis, when such patients are available.

    d) Assess the ability of RAL-centered ART combinations to maintain HIV suppression and CD4 counts following solid-organ transplant.


  • determine the viability of grafted organs in patients with HIV infections [ Time Frame: 3+ years ]
    1. Track adverse events including those attributable to ART therapy, but also routine post-transplant events. Assess the safety and tolerability profile of RAL during the pre and post-transplant period.
    2. Determine graft survival and performance following transplantation in this population and compare to similar data in HIV-negative historical controls.


Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV positive patients, awaiting or listed for organ transplantation, currently taking Raltegravir

Criteria

Inclusion Criteria:

  1. non-pregnant adult patient with CD4 count >200/μL
  2. no concurrent active AIDS-defining infections or malignancy
  3. at least 24 months of well controlled HIV viremia, defined as <50 copies for the majority of the time.
  4. otherwise suitable transplant candidates, actively listed
  5. currently taking Raltegravir for control of HIV infection
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793467

Contacts
Contact: Cameron R Wolfe, MD 9196680789 cameron.wolfe@duke.edu
Contact: Charles B Hicks, MD 9196848111

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 277138270
Contact: Cameron R Wolfe, MD    919-668-0789    cameron.wolfe@duke.edu   
Principal Investigator: Cameron R Wolfe, MD         
Sponsors and Collaborators
Duke University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Cameron R Wolfe, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01793467     History of Changes
Other Study ID Numbers: Pro00036598
Study First Received: February 13, 2013
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014