Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin’s Lymphoma
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ClinicalTrials.gov Identifier: NCT00126243 |
Recruitment Status
:
Terminated
First Posted
: August 3, 2005
Last Update Posted
: August 17, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
AIDS Related Lymphoma | Drug: rituximab Drug: CHOP | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab + CHOP Regimen in Patients With HIV Related Non-Hodgkin’s Lymphomas. ANRS 085 Rituximab |
Study Start Date : | January 1999 |
Study Completion Date : | October 2003 |

- Evaluate the response rate of lymphoma treated
- Duration of response
- Evaluate the time to progression
- Survival
- Safety of rituximab in HIV patients with lymphoma when sequentially administered with chemotherapy

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV positive with a high grade Ann Arbor stage I to IV untreated non-Hodgkin’s lymphoma of B-cell origin confirmed by biopsy. The following histologies are eligible: *Burkitt’s lymphoma, *diffuse large B-cell with standard histological diagnosis, *Burkitt-like and high grade large cell immunoblastic lymphoma with immunophenotyping CD20 positive
- Good and intermediate prognostic group (no more than one of the following prognostic factors: *CD4 below 100/µl, *history of opportunistic infection, *Karnofsky index below 60 percent or ECOG over 2)
- Written inform consent to participate
Exclusion Criteria:
- Active viral hepatitis
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126243
France | |
Service de Medecine Interne Hopital Antoine Beclere | |
Clamart, France, 92140 |
Principal Investigator: | Francois Boue, MD | Service de Medecine Interne Hopital A Beclere Clamart France | |
Study Chair: | Dominique Costagliola | Inserm U 720 |
ClinicalTrials.gov Identifier: | NCT00126243 History of Changes |
Other Study ID Numbers: |
ANRS 085 Rituximab |
First Posted: | August 3, 2005 Key Record Dates |
Last Update Posted: | August 17, 2005 |
Last Verified: | August 2005 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
AIDS related Lymphoma chemotherapy rituximab |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, B-Cell Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |