NCT01165645

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

Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hodgkin Lymphoma
• Stage I Adult Hodgkin Lymphoma
• Stage II Adult Hodgkin Lymphoma
• Stage III Adult Hodgkin Lymphoma
• Stage IV Adult Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	lopinavir	Given orally
DRUG	ritonavir	Given orally
GENETIC	polymerase chain reaction	Correlative studies
OTHER	flow cytometry	Correlative studies
OTHER	enzyme-linked immunosorbent assay	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• Completion: 2011-12-14
• First posted: 2010-07-20
• Last updated: 2022-12-01

Locations

1 site across 1 country: United States