HIV InfectionANRS CO16NCT01164436
Cohort of HIV Associated Lymphomas
An observational study of HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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)). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection
- How many people
- 205 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The recruitment of 80 cases per year is expected. The length of inclusions is 5 years. The follow-up will be of 5 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 collection.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French Cohort of HIV Associated Lymphomas
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:
Read more
- 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).
- Conditions
- HIV Infection
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 year
Secondary outcomes (4)
Survival rate in HIV patients with NHL or HL
Measured: 5 year
Progression-free survival rate in HIV patients with NHL or HL
Measured: 5 year
Levels of EBV in tumors of HIV patients with NHL or HL
measurement of EBV using in situ hybridization applied to paraffin sections
Measured: 5 year
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
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJun 2008
- Primary completionJun 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France, Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France, University Hospital, Grenoble, Dr Irène Joab Hôpital Paul Brousse Villejuif France, Dr Alex Duval Fondation Jean Dausset CEPH, Hopital Antoine Beclere
- Responsible party
- Sponsor
- Investigators
- Caroline BESSON, Principal investigator, Service Hématologie Immunologie Biologie, Hopital BicetreGilles Pialoux, PH, Principal investigator, Hôpital Tenon ParisMarie Caroline Meyonas, PH, Principal investigator, Hôpital St Antoine ParisChristine Katlama, PH, Principal investigator, Hôpital Pitiè SalpétrièreJean Gabarre, MD, Principal investigator, Hôpital Pitiè Salpétrière ParisDominique Salmon, PH, Principal investigator, Hôpital Cochin PARISFrançois Dreyfus, PH, Principal investigator, Hôpital Cochin ParisJean Paul Viard, PH, Principal investigator, Hotel Dieu PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164436
- Sponsor's protocol ID
- 2007-AO0258-45
- Acronym
- ANRS CO16
- Status last verified
- Oct 2017
- First submitted
- 22 Dec 2009
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lievin R, Maillard A, Hendel-Chavez H, Krzysiek R, Lancar R, Algarte-Genin M, Costagliola D, Assoumou L, Taoufik Y, Besson C. Immune reconstitution and evolution of B-cell-stimulating cytokines after R-CHOP therapy for HIV-associated DLBCL. Blood Adv. 2024 Dec 10;8(23):6017-6027. doi: 10.1182/bloodadvances.2024014116.
PubMed 39348664
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Cohort of HIV Associated Lymphomas
- ClinicalTrials.gov ID
- NCT01164436
- Acronym / sponsor ID
- ANRS CO16 / 2007-AO0258-45
- Conditions
- HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France, Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France, University Hospital, Grenoble, Dr Irène Joab Hôpital Paul Brousse Villejuif France, Dr Alex Duval Fondation Jean Dausset CEPH, Hopital Antoine Beclere
- Study start
- Jun 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The recruitment of 80 cases per year is expected. The length of inclusions is 5 years. The follow-up will be of 5 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 collection.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 39348664Lievin R, Maillard A, Hendel-Chavez H, Krzysiek R, Lancar R, Algarte-Genin M, Costagliola D, Assoumou L, Taoufik Y, Besson C. Immune reconstitution and evolution of B-cell-stimulating cytokines after R-CHOP therapy for HIV-associated DLBCL. Blood Adv. 2024 Dec 10;8(23):6017-6027. doi: 10.1182/bloodadvances.2024014116.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline BESSON principal investigator
Service Hématologie Immunologie Biologie, Hopital Bicetre
Gilles Pialoux, PH principal investigator
Hôpital Tenon Paris
Marie Caroline Meyonas, PH principal investigator
Hôpital St Antoine Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01164436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.