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
Last updated: 05/22/2012
NCT ID: NCT01165645
IRB Number:08-006246
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