A Feasibility Study of Co-administering Combination Antiretroviral Therapy (cART) and R-EPOCH Chemotherapy for the Management of ARL
Summary
No standard regimen currently exists for the treatment of AIDS-related lymphoma. Based on the encouraging NCI results with DA-EPOCH, the US AIDS Malignancy Consortium is currently administering a phase II randomized protocol comparing EPOCH with sequential versus concurrent rituximab (AMC protocol 034). In this AMC trial, the decision to co-administer cART is left to the discretion of the treating physician and the patient. While the AMC phase II study may establish an acceptable chemotherapy regimen suitable for further study in a phase III randomized trial, the results will not address adherence, pharmacokinetic interactions or the role of cART in AIDS-related lymphoma. The contribution of cART to the anti-lymphoma efficacy of any regimen needs to be formally studied. Our proposed trial to demonstrate the feasibility of co-administering cART with chemotherapy would justify the use of combined therapy in future AMC/International phase III protocols.
Timeline
- Start
- 2008-02
- Primary completion
- 2012-12
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Efavirenz | Other / unclassified | — | — |
| Subject | Etoposide | Small molecule | — | — |
| Subject | Prednisone | Other / unclassified | — | Oral |
| Subject | Rituximab | Monoclonal antibody | — | — |
| Subject | Tenofovir | Small molecule | — | — |
| Subject | Vincristine | Small molecule | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |