Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma

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
study

- 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,
adalimumab)

- 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
antibiotics)

- 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
inhibitors