Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant
Condition: HIV; Kidney Transplant; Liver Transplant
Intervention: everolimus
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          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.

        Exclusion Criteria:

          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).