Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness
PRIMARY OBJECTIVES: I. Compare TREC positive recent thymic emigrants, and naive CD4+ and
CD8+ T cell numbers between treatment groups. SECONDARY OBJECTIVES: I. Compare
post-vaccination anti-rabies antibody titers between treatment groups. II. Compare
post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12,
INFgamma, TNFalpha, between treatment groups. III. Compare post-vaccination anti-rabies
ELISPOT reaction between treatment groups. OUTLINE: Patients are randomized to 1 of 2
treatment arms. Arm I: Patients receive oral lopinavir and oral ritonavir twice daily for
28 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients
receive no therapy. All patients then receive a neo-antigen rabies vaccine.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups
Stacey Rizza, M.D.
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|