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Transplantation and the Use of Raltegravir in HIV-Infected Patients

NCT01793467 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2017-08-16

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Cameron R Wolfe, MD · Duke University

Eligibility

Min Age
13 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793467 on ClinicalTrials.gov