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

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