LINFOTARGAM: Treatment With Chemotherapy Plus Rituximab and Highly Active Antiretroviral Therapy in Patients With Diffuse Large B Cell Lymphoma and Infection With the Human Immunodeficiency Virus (HIV)

Main objective:

* To evaluate the applicability of the treatment:

  1. To evaluate the treatment toxicity according to the Common Terminology Criteria (CTC) version 3.0 of the National Cancer Institute (NCI).
  2. To evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) administered every 14 days and highly active antiretroviral therapy (HAART) in patients with diffuse large B cell lymphoma (DLBCL) and HIV infection.
  3. To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy (planned dose administered in predicted term).

Secondary objectives:

* To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days (R-CHOP/14):

  1. To determine the global response and complete remission tax.
  2. To evaluate the duration of the response.
  3. To evaluate the probability of event-free survival in 5 years.
  4. To evaluate the probability of global survival in 5 years.
* To identify predictive factors of response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection.
* To evaluate the impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count).

This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HIV infection diagnosed with DLBCL in any stage (I-IV according to the Ann Arbor classification) not previously treated for the lymphoma.
* Patients with CD20-positive diffuse large B-cell lymphoma
* Aged from 18 to 70 years old
* Any score of International Prognostic Index. (It is also applicable in patients with non-Hodgkin lymphoma \[NHL\] infected with HIV.)
* ECOG performance status 0 to 3
* Written informed consent
* Absolute neutrophil count \> 1.5 x 10\^9/L.
* Absence of synchronic or non-synchronic neoplasia with the exception of non-melanoma skin tumors or in situ cervical carcinoma.
* CD4+ lymphocyte count \> 100/µL

Exclusion Criteria:

* Patients with diffuse large B cell lymphoma previously treated.
* Patients with primary central nervous system lymphoma.
* Patients with Burkitt or Burkitt-like NHL.
* CD4+ lymphocyte count \< 100/µL
* Opportunistic infections or other AIDS-related neoplasias in activity.
* Active drug-addiction.
* Pregnant or lactating women or adults of fertile age who do not use an effective contraceptive method.
* Patients with serious altered renal function (creatinine \> 2.5 x upper limit of normal \[ULN\]) or hepatic \[bilirubin, ALT or AST \> 2.5 x ULN\], except if the investigators suspect that they are caused by the disease.
* Cardiac insufficiency with ejection fraction \< 40%
* Patients with serious psychiatric diseases that can interfere with their capacity to understand the study (including alcoholism or active drug-addiction).
* ECOG \> 3
* Patients with a known hypersensitivity to murine proteins or any other component of the study drugs.