Hodgkin Lymphoma Clinical Trial
Official title:
Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness
Verified date | October 2015 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 14, 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups | 90 days | ||
Secondary | Comparison of post-vaccination anti-rabies antibody titers between treatment groups | 90 days | ||
Secondary | Comparison of post-vaccination cytokine levels, including IL1, IL2, IL4, IL6, IL7, IL8, IL10, IL12, INFgamma, TNFalpha, between treatment groups | 90 days | ||
Secondary | Comparison of post-vaccination anti-rabies ELISPOT reaction between treatment groups | 90 days |
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