Examining the Incidence of Oral Human Papillomavirus (HPV) Shedding and Oral Warts After Beginning HAART in HIV-Infected Adults
- Conditions
- HIV Infections
- Registration Number
- NCT01029249
- Lead Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Meet inclusion criteria for and be enrolled in ACTG A5257
- Ability and willingness of participant or legal guardian/representative to provide informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type-specific oral HPV DNA shedding (presence versus absence) 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 Measured at Weeks 16 and 24
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (35)
Rush University Medical Center (2702)
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital ACTG CRS (101)
🇺🇸Boston, Massachusetts, United States
Case CRS (2501)
🇺🇸Cleveland, Ohio, United States
MetroHealth CRS (2503)
🇺🇸Cleveland, Ohio, United States
Houston AIDS Research Team CRS (31473)
🇺🇸Houston, Texas, United States
University of Washington AIDS CRS (1401)
🇺🇸Seattle, Washington, United States
University of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
University of California San Francisco AIDS CRS (801)
🇺🇸San Francisco, California, United States
Vanderbilt Therapeutics CRS (3652)
🇺🇸Nashville, Tennessee, United States
HIV Prevention and Treatment
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania CRS (6201)
🇺🇸Philadelphia, Pennsylvania, United States
Alabama Therapeutics CRS (5801)
🇺🇸Birmingham, Alabama, United States
Moses H. Cone Memorial Hosp. CRS
🇺🇸Greensboro, North Carolina, United States
Cooper Univ. Hosp. CRS (31476)
🇺🇸Camden, New Jersey, United States
Beth Israel Deaconess Medical Center ACTG CRS (103)
🇺🇸Boston, Maryland, United States
University of Southern California CRS (1201)
🇺🇸Los Angeles, California, United States
UCLA CARE Center CRS (601)
🇺🇸Los Angeles, California, United States
Ucsd, Avrc Crs (701)
🇺🇸San Diego, California, United States
Cornell CRS (7804)
🇺🇸New York, New York, United States
Puerto Rico-AIDS CRS (5401)
🇵🇷San Juan, Puerto Rico
University of Miami AIDS CRS (901)
🇺🇸Miami, Florida, United States
Duke Univ. Med. Ctr. Adult CRS (1601)
🇺🇸Durham, North Carolina, United States
Henry Ford Hosp. CRS (31472)
🇺🇸Detroit, Michigan, United States
University of Rochester ACTG CRS (1101)
🇺🇸Rochester, New York, United States
The Miriam Hospital ACTG CRS (2951)
🇺🇸Providence, Rhode Island, United States
Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
🇺🇸Richmond, Virginia, United States
The Ohio State University AIDS CRS (2301)
🇺🇸Colombus, Ohio, United States
The Ponce de Leon Ctr. CRS (5802)
🇺🇸Atlanta, Georgia, United States
IHV Baltimore Treatment CRS (4651)
🇺🇸Baltimore, Maryland, United States
Washington University CRS (2101)
🇺🇸St. Louis, Missouri, United States
Stanford
🇺🇸Palo Alto, California, United States
New Jersey Medical School- Adult Clinical Research Ctr. CRS
🇺🇸Newark, New Jersey, United States
Northwestern University CRS (2701)
🇺🇸Chicago, Illinois, United States
AIDS Care CRS (1108)
🇺🇸Rochester, New York, United States
University of North Carolina AIDS CRS
🇺🇸Chapel Hill, North Carolina, United States