Transplantation and the Use of Raltegravir in HIV-Infected Patients
Completed
Conditions studied: HIV Positive, Organ Transplant Recipient, Active Wait Listing for Organ Transplant
In brief
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.
Key facts
- Study ID
- NCT01793467
- Run by
- Duke University
- People needed
- 17
- Starts
- 2012-10-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-08-16
Who can join
Age: 13 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- non-pregnant adult patient with CD4 count >200/μL
- no concurrent active AIDS-defining infections or malignancy
- at least 24 months of well controlled HIV viremia, defined as <50 copies for the majority of the time.
- otherwise suitable transplant candidates, actively listed
- currently taking Raltegravir for control of HIV infection
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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