Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 35
- Primary Endpoint
- Type-specific oral HPV DNA shedding (presence versus absence)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- 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
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Clinical diagnosis (presence versus absence) of oral warts(Measured at Weeks 16 and 24)
- HPV shedding at one of the pre-HAART visits(Measured at one of the pre-entry visits)
- Plasma HIV-1 RNA suppression(Measured at Weeks 4, 16, and 24)
- 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(Measured at Weeks 16 or 24)
- 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)(Measured during the A5272 study or obtained from stored specimens)
- Percentage and absolute number of CD4 cells that are regulatory T cells (CD4+/CD25+/CD127low) measured from PBMCs(Measured during the A5272 study or obtained from stored specimens)
- Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam(Measured at baseline and Weeks 16, 24, and 48)
- Persistence of HPV DNA of a specific type in throat wash specimens over the time course of the study(Measured during the A5272 study or obtained from stored specimens)
- Salivary total lgA and anti-HPV lgA and S-lgA titers(Measured during the A5272 study or obtained from stored specimens)
- CD4 count change (compared to baseline)(Measured at Weeks 4, 16, and 24)
- Absolute CD4 count (obtained from A5257 study data)(Measured at Weeks 0, 24, and 48 in the A5257 study)
- Percentage and absolute number of CD8 cells that are IFN, tumor necrosis factor (TNF), TGF+, or CD107+ after HPV peptide stimulation measured from PBMCs(Measured during the A5272 study or obtained from stored specimens)
- Serum total anti-HPV lgG titers(Measured during the A5272 study or obtained from stored specimens)
- Number of oral sex partners in the last month(Measured at baseline and Weeks 24 and 48)
- Number of oral sex partners in the last 6 months(Measured at baseline and Weeks 24 and 48)
- Absolute CD8 count (obtained from A5257 study data)(Measured at Weeks 0 and 24 in the A5257 study)
- Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR(Measured during the A5272 study or obtained from stored specimens)