Transplantation and the Use of Raltegravir in HIV-Infected Patients
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.
Organ Transplant Recipient
Active Wait Listing for Organ Transplant
|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|
- 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 ] [ Designated as safety issue: No ]
- Assess Raltegravir viability as a long term HIV treatment drug for patients undergoing transplant [ Time Frame: 3+ years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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.
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793467
|Contact: Cameron R Wolfe, MDfirstname.lastname@example.org|
|Contact: Charles B Hicks, MD||9196848111|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 277138270|
|Contact: Cameron R Wolfe, MD 919-668-0789 email@example.com|
|Principal Investigator: Cameron R Wolfe, MD|
|Principal Investigator:||Cameron R Wolfe, MD||Duke University|