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Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness

18 Years
Open (Enrolling)
Hodgkin Lymphoma, Stage I Adult Hodgkin Lymphoma, Stage II Adult Hodgkin Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage IV Adult Hodgkin Lymphoma

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Trial Information

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.

Inclusion Criteria:

- Adult subjects who are in complete remission at Day +100 after a bone marrow
transplant for Hodgkins Lymphoma

- Normal AST or ALT, serum creatinine and 12-lead electrocardiogram within the previous
6 months

- Females of childbearing potential must have negative beta-HCG (urine or plasma)
within the last month and agree to effective contraception during the course of the

- Willingness and ability to give informed consent

- Willingness and ability to take pills twice a day for 28 days

Exclusion Criteria:

- Known HIV positive

- Screening ALT or AST greater than 3X upper limit of normal

- Baseline QTc greater than 500 msec

- Current treatment with immunosuppressive agent (systemic glucocorticoid,
cyclosporine, mycophenolate, azathioprine, sirolimus, Rituximab, infliximab,

- Current treatment with any of the following: cisapride, ergot derivatives,
amiodarone, quinidine, terfenadine, astemizole, rifampin/rifabutin, carbamazepine,
phenobarbital, sildenafil, St. John's wort, azithromycin, carbamazepine, HIV
anti-virals, methadone, pimozide, phenytoin, sedative hypnotics (midazolam,
triazolam), HMG-CoA reductase inhibitors (lovastatin, simvastatin, atorvastatin)

- Active malignancy requiring chemotherapy or radiation

- Baseline creatinine of > 2.0

- Active infection requiring systemic anti-infective agent (excluding prophylactic

- Hypersensitivity to processed bovine gelatin, chicken protein, neomycin, amphotericin
B or chlortetracycline

- Subject must not be on medications that interact with the metabolism of protease

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Stacey Rizza, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

November 2010

Completion Date:

Related Keywords:

  • Hodgkin Lymphoma
  • Stage I Adult Hodgkin Lymphoma
  • Stage II Adult Hodgkin Lymphoma
  • Stage III Adult Hodgkin Lymphoma
  • Stage IV Adult Hodgkin Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



Mayo Clinic Rochester, Minnesota  55905