Cohort of HIV Associated Lymphomas

HIV Infection Clinical Trial

— ANRS CO16  

Official title:

French Cohort of HIV Associated Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164436
• Other study ID #: 2007-AO0258-45
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: October 31, 2017
• Start date: June 2008
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: June 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections
• Lymphoma, AIDS-Related

Locations

Country	Name	City	State
France	BESSON	Paris

Sponsors (7)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Dr Alex Duval Fondation Jean Dausset CEPH, Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France, Dr Irène Joab Hôpital Paul Brousse Villejuif France, Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France, Hopital Antoine Beclere, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 year
Secondary	Survival rate in HIV patients with NHL or HL		5 year
Secondary	Progression-free survival rate in HIV patients with NHL or HL		5 year
Secondary	Levels of EBV in tumors of HIV patients with NHL or HL	measurement of EBV using in situ hybridization applied to paraffin sections	5 year
Secondary	Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL	measurement of concentrations of IL-6, IL-10, BAFF in plasma	5 year