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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Lopinavir; Ritonavir

Criteria

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