Transplantation and the Use of Raltegravir in HIV-Infected Patients

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. Identifier: NCT01793467
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 16, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Duke University

Brief Summary:

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 or disease
HIV Positive Organ Transplant Recipient Active Wait Listing for Organ Transplant

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 17 participants
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
Actual Study Start Date : October 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

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Ages Eligible for Study:   13 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV positive patients, awaiting or listed for organ transplantation, currently taking Raltegravir

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

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 identifier (NCT number): NCT01793467

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 277138270
Sponsors and Collaborators
Duke University
Merck Sharp & Dohme Corp.
Principal Investigator: Cameron R Wolfe, MD Duke University

Responsible Party: Duke University Identifier: NCT01793467     History of Changes
Other Study ID Numbers: Pro00036598
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: July 2017

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