Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant

Inclusion Criteria

• Solid organ (kidney, kidney/pancreas, or liver) transplant recipient
• Male or female ≥ 18 years of age.
• 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)
• 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.
• CD4+ T cell counts greater than 200 cell/µl within 16 weeks of enrollment and study drug initiation.
• Receiving combination antiretroviral therapy (at least 3 agents)
• 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

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