NCT02429869

Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant

Impact of Everolimus on HIV Persistence Post Kidney (and Kidney/Pancreas) or Liver Transplant

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Zortress (everolimus), the 40-O-(2-hydroxyethyl)-derivative of rapamycin, is an mTOR inhibitor approved for rejection prophylaxis in kidney transplant recipients. mTOR inhibition may favorably impact the HIV viral reservoir, and we hypothesize that adding everolimus to the transplant immunosuppressive regimen of HIV positive transplant recipients will decrease HIV persistence in CD4+ lymphocytes.

Detailed description

Open-label, single arm study that will enroll antiretroviral-treated HIV-infected adults who are doing well post-liver or post-kidney transplant who are eligible and willing to add everolimus to their immunosuppressive regimen (with a target trough level between 3-8 ng/ml). Calcineurin inhibitors will be decreased to obtain a 50% reduction in trough levels with the addition of everolimus. Subjects will be maintained on that regimen for 6 months. Biologic specimens for intensive immunology and virology studies will be obtained before, during and after exposure to everolimus. Samples will be analyzed at screening, baseline (prior to addition of everolimus), and at weeks 8 and 26 (while on everolimus), and week 52 (6 months post everolimus discontinuation).

Conditions

• HIV
• Kidney Transplant
• Liver Transplant

Interventions

Type	Name	Description
DRUG	everolimus

Timeline

• Start date: 2016-02-24
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2015-04-29
• Last updated: 2019-11-19
• Results posted: 2019-11-19

Locations

1 site across 1 country: United States