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

Mayo Clinic

Status: Withdrawn

Conditions: Hodgkin Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage I Adult Hodgkin Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage II Adult Hodgkin Lymphoma

Treatments: Other: laboratory biomarker analysis; Other: flow cytometry; Genetic: polymerase chain reaction; Other: enzyme-linked immunosorbent assay; Drug: ritonavir; Drug: lopinavir

Study type: Interventional

Funder types: Other

Identifiers

NCT01165645

NCI-2010-00880 (Registry Identifier)

08-006246 (Other Identifier)

MC1083 (Other Identifier)

21096 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity.

Treatment:

Drug: lopinavir

Other: enzyme-linked immunosorbent assay

Drug: ritonavir

Other: laboratory biomarker analysis

Genetic: polymerase chain reaction

Other: flow cytometry

Arm II

No Intervention group

Description:

Patients receive no therapy.