Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness
18 Years
N/A
Both
Hodgkin Lymphoma, Stage I Adult Hodgkin Lymphoma, Stage II Adult Hodgkin Lymphoma, Stage III Adult Hodgkin Lymphoma, Stage IV Adult Hodgkin Lymphoma
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
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
Type of Study:
Interventional
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:
No
Principal Investigator
Stacey Rizza, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
MC1083
NCT ID:
NCT01165645
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
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
