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

Official Title: “Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy”

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).

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.

Arms, Groups and Cohorts in this Clinical Trial

• : ACTG A5257 participants
  • Participants in this study will also be enrolled in ACTG A5257.

Primary Measures

• Type-specific oral HPV DNA shedding (presence versus absence)
  • Time Frame: Measured at baseline (measured at pre-entry and entry into A5257) and at Weeks 16 and 24
    Safety Issue?: No
• Persistence of same type HPV DNA shedding from pre-entry/baseline visits to Week 16 and 24 visits
  • Time Frame: Measured at Weeks 16 and 24
    Safety Issue?: No

Secondary Measures

• Clinical diagnosis (presence versus absence) of oral warts
  • Time Frame: Measured at Weeks 16 and 24
    Safety Issue?: No
• HPV shedding at one of the pre-HAART visits
  • Time Frame: Measured at one of the pre-entry visits
    Safety Issue?: No
• CD4 count change (compared to baseline)
  • Time Frame: Measured at Weeks 4, 16, and 24
    Safety Issue?: No
• Plasma HIV-1 RNA suppression
  • Time Frame: Measured at Weeks 4, 16, and 24
    Safety Issue?: No
• Quantitative changes in HPV DNA in oral specimens obtained from participants who have the same HPV subtypes at one of the two pre-HAART visits as well as at Week 16 or 24
  • Time Frame: Measured at Weeks 16 or 24
    Safety Issue?: No
• Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam
  • Time Frame: Measured at baseline and Weeks 16, 24, and 48
    Safety Issue?: No
• Number of oral sex partners in the last month
  • Time Frame: Measured at baseline and Weeks 24 and 48
    Safety Issue?: No
• Number of oral sex partners in the last 6 months
  • Time Frame: Measured at baseline and Weeks 24 and 48
    Safety Issue?: No
• Absolute CD8 count (obtained from A5257 study data)
  • Time Frame: Measured at Weeks 0 and 24 in the A5257 study
    Safety Issue?: No
• Absolute CD4 count (obtained from A5257 study data)
  • Time Frame: Measured at Weeks 0, 24, and 48 in the A5257 study
    Safety Issue?: No
• Percentage and absolute number of CD4 cells that are interleukin (IL)-2+/interferon (IFN)+ or transforming growth factor (TGF)+ after HPV peptide stimulation measured from peripheral blood mononuclear cells (PBMCs)
  • Time Frame: Measured during the A5272 study or obtained from stored specimens
    Safety Issue?: No
• Percentage and absolute number of CD8 cells that are IFN, tumor necrosis factor (TNF), TGF+, or CD107+ after HPV peptide stimulation measured from PBMCs
  • Time Frame: Measured during the A5272 study or obtained from stored specimens
    Safety Issue?: No
• Percentage and absolute number of CD4 cells that are regulatory T cells (CD4+/CD25+/CD127low) measured from PBMCs
  • Time Frame: Measured during the A5272 study or obtained from stored specimens
    Safety Issue?: No
• Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR
  • Time Frame: Measured during the A5272 study or obtained from stored specimens
    Safety Issue?: No
• Persistence of HPV DNA of a specific type in throat wash specimens over the time course of the study
  • Time Frame: Measured during the A5272 study or obtained from stored specimens
    Safety Issue?: No
• Salivary total lgA and anti-HPV lgA and S-lgA titers
  • Time Frame: Measured during the A5272 study or obtained from stored specimens
    Safety Issue?: No
• Serum total anti-HPV lgG titers
  • Time Frame: Measured during the A5272 study or obtained from stored specimens
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AIDS Clinical Trials Group Other

Overall Clinical Trial Officials and Contacts

Caroline Shiboski, DDS, MPH, PhD Study Chair Department of Orofacial Sciences, UCSF AIDS OHARA  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01029249

Study ID Number: ACTG A5272

ClinicalTrials.gov Identifier: NCT01029249

Health Authority: United States: Federal Government

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