title: The exclusion of people living with HIV (PLWH) from clinical trials in lymphoma.
abstract: BACKGROUND
  The prognosis of non-Hodgkin lymphoma and Hodgkin lymphoma is not affected by HIV serostatus, yet people living with HIV (PLWH) are frequently excluded from clinical trials in lymphoma.
  
  
  METHODS
  The UK NIHR Clinical Research Network Study Portfolio website was used to identify all the open clinical trials in lymphoma in the United Kingdom in January 2015. Trials that excluded PLWH were further investigated to evaluate if the exclusion was justified by scientific evidence.
  
  
  RESULTS
  We identified 56 multicentre open clinical trials in lymphoma including 46 interventional trials. People living with HIV were excluded from 32 interventional trials (70%). We identified a biologically valid reason (a potential increased risk of greater immunosuppression) for excluding PLWH from one trial and possibly for one optional arm in another study.
  
  
  CONCLUSIONS
  There was no scientific or safety justification for excluding PLWH from most lymphoma clinical trials included on the NIHR portfolio. A clear justification for excluding PLWH was not offered in the available protocols. The exclusion of PLWH should be explicitly justified on scientific grounds in protocols to minimise stigmatisation.
authors: Department of HIV Medicine, Chelsea & Westminster Hospital, London SW10 9NH, UK.
authors: Serena
authors: S
authors: Venturelli
authors: Department of Oncology, National Centre for HIV Malignancies, Chelsea & Westminster Hospital, London SW10 9NH, UK.
authors: Alessia
authors: A
authors: Dalla Pria
authors: Department of HIV Medicine, Chelsea & Westminster Hospital, London SW10 9NH, UK.
authors: Katrina
authors: K
authors: Stegmann
authors: Tumour Group Lead for Haematology and Brain Trials, Cancer Research UK and UCL Cancer Trials Centre, 90 Tottenham Court Road, London W1T 4TJ, UK.
authors: Paul
authors: P
authors: Smith
authors: Department of Oncology, National Centre for HIV Malignancies, Chelsea & Westminster Hospital, London SW10 9NH, UK.
authors: Mark
authors: M
authors: Bower
mesh_terms: D019380:Anti-HIV Agents / Q000493:pharmacokinetics / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D004347:Drug Interactions; D015658:HIV Infections / Q000188:drug therapy / Q000378:metabolism; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000378:metabolism; D015337:Multicenter Studies as Topic / Q000592:standards / Q000706:statistics & numerical data*; D064887:Observational Studies as Topic / Q000706:statistics & numerical data; D018579:Patient Selection; D016079:Refusal to Treat / Q000706:statistics & numerical data*; D006113:United Kingdom
chemical_list: D019380:Anti-HIV Agents; D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents