NCT00421486

Brief Summary

Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. HIV-infected men having sex with men /MSM) are strongly associated with a higher prevalence of genitoanal HPV-infection, and perianal HPV-infections have been detected in up to 90% of HIV-positive men. The data concerning the incidence of oral HPV-infection in HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting. Thus, this prospective study mainly focuses on the incidence and prevalence of oral HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

10.8 years

First QC Date

January 10, 2007

Last Update Submit

January 20, 2016

Conditions

Papillomavirus InfectionsHIV Infections

Keywords

Oral human papillomavirus infectionHIV-infectionHigh-risk HPV viral loadOral human papillomavirus infection in HIV-positive menTreatment ExperiencedTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Spectrum of HPV types and associated clinical lesions

    swabs will be obtained approximately every 6 months

Interventions

Oral swabs for HPV-typing and high-risk HPV-determinationPROCEDURE

Oral swabs for HPV-typing and high-risk HPV-determination

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV-infected men who have sex with men

You may qualify if:

  • HIV-infected men who have sex with men

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

Institute of Virology, University of Cologne

Cologne, North Rhine-Westphalia, 50935, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

Papillomavirus InfectionsHIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Alexander Kreuter, MD

    Department of Dermatology, Ruhr University Bochum

    PRINCIPAL INVESTIGATOR

  • Norbert Brockmeyer, MD

    Department of Dermatology, Ruhr University Bochum

    PRINCIPAL INVESTIGATOR

  • Ulrike Wieland, MD

    Institute of Virology, University of Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Kreuter, MD

CONTACT

0049/234/5093439a.kreuter@derma.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 12, 2007

Study Start

March 1, 2006

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

DE(2)