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Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

18 Years
Open (Enrolling)
HIV Infections

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Trial Information

Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

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.

Inclusion Criteria:

- Meet inclusion criteria for and be enrolled in ACTG A5257

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Type-specific oral HPV DNA shedding (presence versus absence)

Outcome Time Frame:

Measured at baseline (measured at pre-entry and entry into A5257) and at Weeks 16 and 24

Safety Issue:


Principal Investigator

Caroline Shiboski, DDS, MPH, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Orofacial Sciences, UCSF AIDS OHARA


United States: Federal Government

Study ID:

ACTG A5272



Start Date:

January 2010

Completion Date:

May 2013

Related Keywords:

  • HIV Infections
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



StanfordStanford, California  94305
Alabama Therapeutics CRS (5801)Birmingham, Alabama  35294-2050
UCLA CARE Center CRS (601)Los Angeles, California  90095
University of Southern California CRS (1201)Los Angeles, California  90033
Ucsd, Avrc Crs (701)San Diego, California  92103
University of California San Francisco AIDS CRS (801)San Francisco, California  94110
University of Miami AIDS CRS (901)Miami, Florida  33139
The Ponce de Leon Ctr. CRS (5802)Atlanta, Georgia  30308
Rush University Medical Center (2702)Chicago, Illinois  60612
Northwestern University CRS (2701)Chicago, Illinois  60611
IHV Baltimore Treatment CRS (4651)Baltimore, Maryland  21201
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Massachusetts General Hospital ACTG CRS (101)Boston, Massachusetts  02114
Henry Ford Hosp. CRS (31472)Detroit, Michigan  48202
Washington University CRS (2101)St. Louis, Missouri  63110
Cooper Univ. Hosp. CRS (31476)Camden, New Jersey  08103
New Jersey Medical School- Adult Clinical Research Ctr. CRSNewark, New Jersey  07103
Cornell CRS (7804)New York, New York  10011
HIV Prevention and TreatmentNew York, New York  10032
University of Rochester ACTG CRS (1101)Rochester, New York  14642
AIDS Care CRS (1108)Rochester, New York  14607
University of North Carolina AIDS CRSChapel Hill, North Carolina  27514
Duke Univ. Med. Ctr. Adult CRS (1601)Durham, North Carolina  27710
Moses H. Cone Memorial Hosp. CRSGreensboro, North Carolina  27401
University of Cincinnati CRSCincinnati, Ohio  45267
MetroHealth CRS (2503)Cleveland, Ohio  44109
Case CRS (2501)Cleveland, Ohio  44106
The Ohio State University AIDS CRS (2301)Colombus, Ohio  43210
Hospital of the University of Pennsylvania CRS (6201)Philadelphia, Pennsylvania  19104
The Miriam Hospital ACTG CRS (2951)Providence, Rhode Island  02906
Vanderbilt Therapeutics CRS (3652)Nashville, Tennessee  37232
Houston AIDS Research Team CRS (31473)Houston, Texas  77030
Virginia Commonwealth Univ. Medical Ctr. CRS (31475)Richmond, Virginia  23219
University of Washington AIDS CRS (1401)Seattle, Washington  98104