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Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients (GAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742375
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
Sciensano
Information provided by (Responsible Party):
prof. dr. Philip Roelandt, Universitaire Ziekenhuizen Leuven

Brief Summary:
The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Diagnostic Test: HPV genotyping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HPV genotyping Diagnostic Test: HPV genotyping
Quantitative HPV genotyping on anal swab




Primary Outcome Measures :
  1. Incidence of HPV subtypes in HIV-positive patients [ Time Frame: 1 minute ]
    Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment


Secondary Outcome Measures :
  1. Correlation between high-resolution anoscopy findings and quantitative HPV genotyping [ Time Frame: 30 minutes up to 10 days ]
    Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures)
  • Referred for high-resolution anoscopy

Exclusion criteria

  • Documented AIN (treated or untreated)
  • Local anal inflammation (proctitis) and/or acute fissure

Information from the National Library of Medicine

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): NCT03742375


Contacts
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Contact: Philip Roelandt, MD PhD +32 16 34 42 25 philip.roelandt@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Philip Roelandt, MD PhD    +32 16 34 42 25    philip.roelandt@uzleuven.be   
Sub-Investigator: Jan Wyndaele, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Sciensano
Investigators
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Principal Investigator: Philip Roelandt, MD PhD Universitaire Ziekenhuizen Leuven
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Responsible Party: prof. dr. Philip Roelandt, Assistant head of clinic Gastroenterology, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03742375    
Other Study ID Numbers: S60050
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by prof. dr. Philip Roelandt, Universitaire Ziekenhuizen Leuven:
Human Papilloma Virus
Anal Intraepithelial Neoplasia
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Neoplasms
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases