Status:
WITHDRAWN
Lopinavir and Ritonavir in Improving Immune Response to Vaccines in Patients With Complete Remission Following A Bone Marrow Transplant for Hodgkin Lymphoma
Lead Sponsor:
Mayo Clinic
Conditions:
Hodgkin Lymphoma
Stage I Adult Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 immun...
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01165645
Start Date
November 1 2010
End Date
December 14 2011
Last Update
December 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905