Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma
Study Details
Study Description
Brief Summary
RATIONALE: HIV protease inhibitors, including Lopinavir/Ritonavir have intrinsic anti-apoptotic properties in addition to their anti-viral effect on HIV. This anti-apoptotic effect may boost the immune system to help the body create a better immune response to vaccines. PURPOSE: This randomized clinical trial studies giving lopinavir and ritonavir together in improving immune response to vaccines in patients with complete remission following a bone marrow transplant for Hodgkin lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity. |
Drug: lopinavir
Given orally
Other Names:
Drug: ritonavir
Given orally
Other Names:
Genetic: polymerase chain reaction
Correlative studies
Other Names:
Other: flow cytometry
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
| No Intervention: Arm II Patients receive no therapy. |
Outcome Measures
Primary Outcome Measures
- Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups [90 days]
Secondary Outcome Measures
- Comparison of post-vaccination anti-rabies antibody titers between treatment groups [90 days]
- Comparison of post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups [90 days]
- Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups [90 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult subjects who are in complete remission at Day +100 after a bone marrow transplant for Hodgkins Lymphoma
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Normal AST or ALT, serum creatinine and 12-lead electrocardiogram within the previous 6 months
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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
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Willingness and ability to give informed consent
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Willingness and ability to take pills twice a day for 28 days
Exclusion Criteria:
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Known HIV positive
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Screening ALT or AST greater than 3X upper limit of normal
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Baseline QTc greater than 500 msec
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Current treatment with immunosuppressive agent (systemic glucocorticoid, cyclosporine, mycophenolate, azathioprine, sirolimus, Rituximab, infliximab, adalimumab)
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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)
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Active malignancy requiring chemotherapy or radiation
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Baseline creatinine of > 2.0
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Active infection requiring systemic anti-infective agent (excluding prophylactic antibiotics)
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Hypersensitivity to processed bovine gelatin, chicken protein, neomycin, amphotericin B or chlortetracycline
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Subject must not be on medications that interact with the metabolism of protease inhibitors
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Study Chair: Stacey Rizza, M.D., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MC1083
- NCI-2010-00880
- MC1083
- 08-006246
- 21096