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Eligibility
for people ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

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

Details

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).

Keywords

HIV Kidney Transplant Liver Transplant Everolimus Sirolimus

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Solid organ (kidney, kidney/pancreas, or liver) transplant recipient
  2. Male or female ≥ 18 years of age.
  3. Documentation of HIV-1 infection diagnosis as evidenced by any licensed ELISA and confirmation by Western Blot, or documented history of detectable HIV-1 RNA)
  4. HIV-1 plasma RNA <50 copies/ml for at least 2 years with at least one measurement per year and most recent viral load within 16 weeks of enrollment and study drug initiation. Episodes of a single HIV plasma RNA 50 - 500 copies/ml will not exclude participation if the subsequent HIV plasma RNA was <50 copies/ml.
  5. CD4+ T cell counts greater than 200 cell/µl within 16 weeks of enrollment and study drug initiation.
  6. Receiving combination antiretroviral therapy (at least 3 agents)
  7. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

You CAN'T join if...

  1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  3. Patients who are intending to modify antiretroviral therapy in the next 6 months for any reason.
  4. Serious illness requiring hospitalization or parenteral antibiotics within preceding 3 months.
  5. A screening hemoglobin below 11.5 g/dL.
  6. A screening TSH consistent with hypothyroidism.
  7. Significant renal disease (eGFR < 60 ml/min) or acute nephritis
  8. Clinically active hepatitis as evidenced by clinical jaundice or Grade 2 or higher liver function test abnormalities.
  9. Hepatic cirrhosis or decompensated chronic liver disease.
  10. Concurrent treatment with immunomodulatory drugs, such an interferon-alpha, or exposure to any immunomodulatory drug in past 16 weeks (outside of standard immunosuppression).

Location

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02429869
Phase
Phase 4
Lead Scientist
Peter Stock
Study Type
Interventional
Last Updated
September 12, 2016