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

Hodgkin Lymphoma Clinical Trial

Official title:

Lopinavir/Ritonavir as an Immunomodulator to Enhance Vaccine Responsiveness

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01165645
• Other study ID #: MC1083
• Secondary ID: NCI-2010-00880MC
• Status: Withdrawn
• Phase: N/A
• Start date: November 2010
• Est. completion date: December 14, 2011

Study information

• Verified date: October 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

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

Intervention

Drug:
• lopinavir
Given orally
• ritonavir
Given orally

Genetic:
• polymerase chain reaction
Correlative studies

Other:
• flow cytometry
Correlative studies
• enzyme-linked immunosorbent assay
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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