Overview

This trial is active, not recruiting.

Condition hiv infection
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France
Start date June 2008
End date June 2015
Trial size 400 participants
Trial identifier NCT01164436, 2007-AO0258-45

Summary

The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France, their incidence is estimated to 100 cases per year (data from the "Base de données Hospitalière Française sur l'Infection à VIH" (FHDH)). The main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV) and HHV8) and molecular oncogenic events. A better understanding of these different pathways, give the possibility to design specific treatments. The treatment of these lymphomas is not standardized. A prospective study of patients with HIV associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. We propose a prospective multicentric study of these patients.

The main objectives of this prospective study are to:

- evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV

- perform an observational study of the treatment and outcome of these patients out of the context of clinical trials,

- study the differentiation and activation of B-cell populations,

- better understand the role of specific T cell responses in the control of EBV infection,

- allow other biological studies from the ANRS group " Lymphome et VIH ".

The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S Prevot* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and tumour (P.Morand* , V.Boyer* ), to investigate the EBV-T cell responses (G.Carcelain) and the presence and reactivation of EBV in peripheral B cells (C.Amiel* , JC Nicolas) and in tumoral samples (M.Raphael* , I.Joab* ). The other mechanisms of lymphomagenesis in HIV infection will be studied by the analysis of the sub-populations of B-cells in terms of activation and differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Correlation between EBV viral load and plasma HIV RNA viral load and CD4 cell count in HIV-infected patients with lymphomas (LNH or LH) at the time of lymphoma diagnosis
time frame: 5 year

Secondary Outcomes

Measure
Survival rate in HIV patients with NHL or HL
time frame: 5 year
Progression-free survival rate in HIV patients with NHL or HL
time frame: 5 year
Levels of EBV in tumors of HIV patients with NHL or HL
time frame: 5 year
Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL
time frame: 5 year

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Male and female patients over 18 years of age - patients with HIV-1 or 2 infection - with Non Hodgkin's lymphomas (NHL) or Hodgkin lymphomas (HL) in the diagnosis or in relapse - sign an informed consent Exclusion Criteria: - patients who suffered from acute leukemia - patients treated for lymphoïd blood disease - Patients whose lymphomas treatment was stopped for less than 3 months - unaffiliated to the social healthy security french system

Additional Information

Official title French Cohort of HIV Associated Lymphomas
Principal investigator Caroline BESSON
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).