Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no patients enrolled
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Stage I Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage II Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage III Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage IV Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| lopinavir | Drug | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| ritonavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral lopinavir and ritonavir twice daily for 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: lopinavir
- Drug: ritonavir
- Genetic: polymerase chain reaction
- Other: flow cytometry
- Other: enzyme-linked immunosorbent assay
- Other: laboratory biomarker analysis
- type
- NO_INTERVENTION
- label
- Arm II
- description
- Patients receive no therapy.
Primary outcomes (1)
- measure
- Comparison of TREC positive recent thymic emigrants, and naive CD4+ and CD8+ T cell numbers between treatment groups
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available