Papillomavirus InfectionsNCT00421486
Oral Human Papillomavirus Infection in HIV-infected Men
An observational study of Papillomavirus Infections and HIV Infections, run by Deutsche Luft und Raumfahrt at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections, HIV Infections
- What is being tested?
- Oral swabs for HPV-typing and high-risk HPV-determination
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2006to Jan 2018
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-infected men who have sex with men
Who may be able to join
- HIV-infected men who have sex with men
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Dermatology, Ruhr University Bochum
Bochum, North Rhine-Westphalia, 44791
Alexander Kreuter, MD, 0049/234/5093439, a.kreuter@derma.de
Alexander Kreuter, MD
- Recruiting
Institute of Virology, University of Cologne
Cologne, North Rhine-Westphalia, 50935
Ulrike Wieland, MD
Ulrike Wieland, MD
About this study
Official title: Incidence, Prevalence, Spectrum of HPV-types, and Viral Load Determination of High-risk Human Papillomavirus Infection of the Oral Cavity in HIV-infected Men Who Have Sex With Men
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.
Read the detailed description
Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. Estimated prevalences of subclinical genital HPV-infection in the immunocompetent sexually active population range from 10 to above 50%. Genetic or iatrogenic immunosuppression is known to play a decisive role in the initiation of a variety of cutaneous neoplasias and their precursor lesions. In this context, HPV-associated anogenital malignancies occur with high frequency in patients with HIV-infection. In several studies, perianal HPV-infections have been detected in up to 90% of HIV-positive men and a high incidence of anal dysplasia has been reported in these patients. 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.
- Conditions
- Papillomavirus Infections, HIV Infections
- Being tested
- Oral swabs for HPV-typing and high-risk HPV-determination
- Keywords
- Oral human papillomavirus infection, HIV-infection, High-risk HPV viral load, Oral human papillomavirus infection in HIV-positive men, Treatment Experienced, Treatment Naive
- Medical subject headings
- Papillomavirus Infections, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral swabs for HPV-typing and high-risk HPV-determinationProcedure or surgery
Oral swabs for HPV-typing and high-risk HPV-determination
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectrum of HPV types and associated clinical lesions
Measured: swabs will be obtained approximately every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startMar 2006
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsche Luft und Raumfahrt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexander Kreuter, Deutsche Luft und Raumfahrt
- Investigators
- Alexander Kreuter, MD, Principal investigator, Department of Dermatology, Ruhr University BochumNorbert Brockmeyer, MD, Principal investigator, Department of Dermatology, Ruhr University BochumUlrike Wieland, MD, Principal investigator, Institute of Virology, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421486
- Sponsor's protocol ID
- 01 KI 0501
- Status last verified
- Jan 2016
- First submitted
- 10 Jan 2007
- Last updated
- 21 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Prevalence, Spectrum of HPV-types, and Viral Load Determination of High-risk Human Papillomavirus Infection of the Oral Cavity in HIV-infected Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00421486
- Acronym / sponsor ID
- 01 KI 0501
- Conditions
- Papillomavirus Infections, HIV Infections
- Keywords
- Oral human papillomavirus infection, HIV-infection, High-risk HPV viral load, Oral human papillomavirus infection in HIV-positive men, Treatment Experienced, Treatment Naive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Deutsche Luft und RaumfahrtOther government
- Study start
- Mar 2006
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 12 Jan 2007 (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.
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.
Detailed description
Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. Estimated prevalences of subclinical genital HPV-infection in the immunocompetent sexually active population range from 10 to above 50%. Genetic or iatrogenic immunosuppression is known to play a decisive role in the initiation of a variety of cutaneous neoplasias and their precursor lesions. In this context, HPV-associated anogenital malignancies occur with high frequency in patients with HIV-infection. In several studies, perianal HPV-infections have been detected in up to 90% of HIV-positive men and a high incidence of anal dysplasia has been reported in these patients. 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected men who have sex with men
Key inclusion criteria (1 listed)
- HIV-infected men who have sex with men
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral swabs for HPV-typing and high-risk HPV-determinationOral swabs for HPV-typing and high-risk HPV-determination | Procedure or surgery | – |
Primary outcome
Spectrum of HPV types and associated clinical lesions
Time frame: swabs will be obtained approximately every 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Deutsches Kompetenznetz HIV/AIDSLink provided by the sponsor.
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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.
Alexander Kreuter, MD principal investigator
Department of Dermatology, Ruhr University Bochum
Norbert Brockmeyer, MD principal investigator
Department of Dermatology, Ruhr University Bochum
Ulrike Wieland, MD principal investigator
Institute of Virology, University of Cologne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillomavirus Infections and HIV Infections, run by Deutsche Luft und Raumfahrt at 2 sites in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Kreuter, MD (0049/234/5093439, a.kreuter@derma.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectrum of HPV types and associated clinical lesions (time frame: swabs will be obtained approximately every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2016.