Transplantation and the Use of Raltegravir in HIV-Infected Patients
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|ClinicalTrials.gov Identifier: NCT01793467|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 16, 2017
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|
|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|
|Primary Completion Date :||June 2017|
|Study Completion Date :||June 2017|
- 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 ]
- Assess Raltegravir viability as a long term HIV treatment drug for patients undergoing transplant [ Time Frame: 3+ years ]
- Characterize the effect of raltegravir-based regimens on the pre and post-transplant endocrine and cardiovascular effects
- Evaluate drug-drug interactions between raltegravir and current transplant immunosuppressant regimens.
- 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 ]
- 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.
- Determine graft survival and performance following transplantation in this population and compare to similar data in HIV-negative historical controls.
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): NCT01793467
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 277138270|
|Principal Investigator:||Cameron R Wolfe, MD||Duke University|