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Examining the Incidence of Oral Human Papillomavirus (HPV) Shedding and Oral Warts After Beginning HAART in HIV-Infected Adults

NCT ID: NCT01029249

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-05-31

Brief Summary

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Oral human papillomavirus (HPV) and oral warts are common health concerns for HIV-infected people. This study will examine the frequency of oral HPV DNA shedding and oral warts in HIV-infected people who are enrolled in ACTG A5257 and who are beginning treatment with highly active antiretroviral therapy (HAART).

Detailed Description

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Oral HPV infection occurs at a higher rate among HIV-infected people than among the general population. Recent research in the United States and Europe has also found that HIV-infected people have a higher risk of oral and oropharyngeal squamous cell cancer than HIV-uninfected people. In one study, it was found that HPV seropositivity was associated with an increased risk of squamous cell carcinoma of the oropharynx (SCCOP). In addition to SCCOP, another HPV-related health concern is oral warts, a condition for which there is no effective treatment. Even after beginning treatment with highly active antiretroviral therapy (HAART), active HPV replication in the mouth and oropharynx may persist in HIV-infected people, leading to an increased risk of SCCOP and oral warts. The purpose of this study is to evaluate the frequency of oral HPV DNA shedding and oral warts in HIV-infected people prior to HAART initiation and at regular time points after HAART initiation.

ACTG A5257 is a study that is comparing the effectiveness of three non-nucleoside reverse transcriptase inhibitor (NNRTI)-sparing HAART regimens in treatment-naïve participants. This study will enroll participants from the ACTG A5257 study. Participants will attend a baseline study visit at the same time as their ACTG A5257 baseline study visit. At baseline and at Week 4, 16, 24, and 48 study visits, participants will undergo an examination of their mouth, throat wash and saliva collection, and behavioral questionnaires. A blood collection will also occur at Week 24.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACTG A5257 participants

Participants in this study will also be enrolled in ACTG A5257.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion Criteria

* Co-enrollment in A5260s
* Has begun receiving HAART as part of the A5257 study
* Has ever received an HPV vaccine or plans to receive an HPV vaccine in the 6 months after study entry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Shiboski, DDS, MPH, PhD

Role: STUDY_CHAIR

Department of Orofacial Sciences, UCSF AIDS OHARA

Mark A. Jacobson, MD

Role: STUDY_CHAIR

UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital

Locations

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Alabama Therapeutics CRS (5801)

Birmingham, Alabama, United States

Site Status

University of Southern California CRS (1201)

Los Angeles, California, United States

Site Status

UCLA CARE Center CRS (601)

Los Angeles, California, United States

Site Status

Stanford

Palo Alto, California, United States

Site Status

Ucsd, Avrc Crs (701)

San Diego, California, United States

Site Status

University of California San Francisco AIDS CRS (801)

San Francisco, California, United States

Site Status

University of Miami AIDS CRS (901)

Miami, Florida, United States

Site Status

The Ponce de Leon Ctr. CRS (5802)

Atlanta, Georgia, United States

Site Status

Northwestern University CRS (2701)

Chicago, Illinois, United States

Site Status

Rush University Medical Center (2702)

Chicago, Illinois, United States

Site Status

IHV Baltimore Treatment CRS (4651)

Baltimore, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center ACTG CRS (103)

Boston, Maryland, United States

Site Status

Massachusetts General Hospital ACTG CRS (101)

Boston, Massachusetts, United States

Site Status

Henry Ford Hosp. CRS (31472)

Detroit, Michigan, United States

Site Status

Washington University CRS (2101)

St Louis, Missouri, United States

Site Status

Cooper Univ. Hosp. CRS (31476)

Camden, New Jersey, United States

Site Status

New Jersey Medical School- Adult Clinical Research Ctr. CRS

Newark, New Jersey, United States

Site Status

Cornell CRS (7804)

New York, New York, United States

Site Status

HIV Prevention and Treatment

New York, New York, United States

Site Status

AIDS Care CRS (1108)

Rochester, New York, United States

Site Status

University of Rochester ACTG CRS (1101)

Rochester, New York, United States

Site Status

University of North Carolina AIDS CRS

Chapel Hill, North Carolina, United States

Site Status

Duke Univ. Med. Ctr. Adult CRS (1601)

Durham, North Carolina, United States

Site Status

Moses H. Cone Memorial Hosp. CRS

Greensboro, North Carolina, United States

Site Status

University of Cincinnati CRS

Cincinnati, Ohio, United States

Site Status

Case CRS (2501)

Cleveland, Ohio, United States

Site Status

MetroHealth CRS (2503)

Cleveland, Ohio, United States

Site Status

The Ohio State University AIDS CRS (2301)

Colombus, Ohio, United States

Site Status

Hospital of the University of Pennsylvania CRS (6201)

Philadelphia, Pennsylvania, United States

Site Status

The Miriam Hospital ACTG CRS (2951)

Providence, Rhode Island, United States

Site Status

Vanderbilt Therapeutics CRS (3652)

Nashville, Tennessee, United States

Site Status

Houston AIDS Research Team CRS (31473)

Houston, Texas, United States

Site Status

Virginia Commonwealth Univ. Medical Ctr. CRS (31475)

Richmond, Virginia, United States

Site Status

University of Washington AIDS CRS (1401)

Seattle, Washington, United States

Site Status

Puerto Rico-AIDS CRS (5401)

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.

Reference Type BACKGROUND
PMID: 18235120 (View on PubMed)

Related Links

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http://clinicaltrials.gov/ct2/show/NCT00811954

Click here for the ACTG A5257 ClinicalTrials.gov study record.

Other Identifiers

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1U01AI068636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ACTG A5272

Identifier Type: -

Identifier Source: org_study_id