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)
Condition: HIV Infections; Diffuse Large B Cell Lymphoma
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 4

Summary: 
      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).
    

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

Intervention name(s): R-CHOP; Highly active antiretroviral therapy; Central nervous system (CNS) prophylaxis; Prophylaxis of opportunistic infections and support treatment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cyclophosphamide 750 mg/m2 i.v. day 1
Adriamycin 50 mg/m2 i.v. day 1
Vincristine 1,4 mg/m2 i.v. day 1
Prednisone 100 mg i.v or oral. days 1-5.; Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.; methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg); Pegfilgrastim
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffuse large B cell lymphoma; HIV; R-CHOP; Highly active antiretroviral therapy; Treatment Experienced