Clinical trial NCT01029249: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in this study will also be enrolled in ACTG A5257.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Type-specific oral HPV DNA shedding (presence versus absence)
timeFrame: Measured at baseline (measured at pre-entry and entry into A5257) and at Weeks 16 and 24
measure: Persistence of same type HPV DNA shedding from pre-entry/baseline visits to Week 16 and 24 visits
timeFrame: Measured at Weeks 16 and 24
Secondary outcomes:
measure: Clinical diagnosis (presence versus absence) of oral warts
timeFrame: Measured at Weeks 16 and 24
measure: HPV shedding at one of the pre-HAART visits
timeFrame: Measured at one of the pre-entry visits
measure: CD4 count change (compared to baseline)
timeFrame: Measured at Weeks 4, 16, and 24
measure: Plasma HIV-1 RNA suppression
timeFrame: Measured at Weeks 4, 16, and 24
measure: 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
timeFrame: Measured at Weeks 16 or 24
measure: Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam
timeFrame: Measured at baseline and Weeks 16, 24, and 48
measure: Number of oral sex partners in the last month
timeFrame: Measured at baseline and Weeks 24 and 48
measure: Number of oral sex partners in the last 6 months
timeFrame: Measured at baseline and Weeks 24 and 48
measure: Absolute CD8 count (obtained from A5257 study data)
timeFrame: Measured at Weeks 0 and 24 in the A5257 study
measure: Absolute CD4 count (obtained from A5257 study data)
timeFrame: Measured at Weeks 0, 24, and 48 in the A5257 study
measure: 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)
timeFrame: Measured during the A5272 study or obtained from stored specimens
measure: Percentage and absolute number of CD8 cells that are IFN, tumor necrosis factor (TNF), TGF+, or CD107+ after HPV peptide stimulation measured from PBMCs
timeFrame: Measured during the A5272 study or obtained from stored specimens
measure: Percentage and absolute number of CD4 cells that are regulatory T cells (CD4+/CD25+/CD127low) measured from PBMCs
timeFrame: Measured during the A5272 study or obtained from stored specimens
measure: Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR
timeFrame: Measured during the A5272 study or obtained from stored specimens
measure: Persistence of HPV DNA of a specific type in throat wash specimens over the time course of the study
timeFrame: Measured during the A5272 study or obtained from stored specimens
measure: Salivary total lgA and anti-HPV lgA and S-lgA titers
timeFrame: Measured during the A5272 study or obtained from stored specimens
measure: Serum total anti-HPV lgG titers
timeFrame: Measured during the A5272 study or obtained from stored specimens
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Therapeutics CRS (5801)
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California CRS (1201)
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Center CRS (601)
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: San Diego
country: United States
facility: Ucsd, Avrc Crs (701)
state: California
city: San Francisco
country: United States
facility: University of California San Francisco AIDS CRS (801)
state: California
city: Miami
country: United States
facility: University of Miami AIDS CRS (901)
state: Florida
city: Atlanta
country: United States
facility: The Ponce de Leon Ctr. CRS (5802)
state: Georgia
city: Chicago
country: United States
facility: Northwestern University CRS (2701)
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center (2702)
state: Illinois
city: Baltimore
country: United States
facility: IHV Baltimore Treatment CRS (4651)
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center ACTG CRS (103)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ACTG CRS (101)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hosp. CRS (31472)
state: Michigan
city: St. Louis
country: United States
facility: Washington University CRS (2101)
state: Missouri
city: Camden
country: United States
facility: Cooper Univ. Hosp. CRS (31476)
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School- Adult Clinical Research Ctr. CRS
state: New Jersey
city: New York
country: United States
facility: Cornell CRS (7804)
state: New York
city: New York
country: United States
facility: HIV Prevention and Treatment
state: New York
city: Rochester
country: United States
facility: AIDS Care CRS (1108)
state: New York
city: Rochester
country: United States
facility: University of Rochester ACTG CRS (1101)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina AIDS CRS
state: North Carolina
city: Durham
country: United States
facility: Duke Univ. Med. Ctr. Adult CRS (1601)
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hosp. CRS
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati CRS
state: Ohio
city: Cleveland
country: United States
facility: Case CRS (2501)
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth CRS (2503)
state: Ohio
city: Colombus
country: United States
facility: The Ohio State University AIDS CRS (2301)
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania CRS (6201)
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital ACTG CRS (2951)
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Therapeutics CRS (3652)
state: Tennessee
city: Houston
country: United States
facility: Houston AIDS Research Team CRS (31473)
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
state: Virginia
city: Seattle
country: United States
facility: University of Washington AIDS CRS (1401)
state: Washington
city: San Juan
country: Puerto Rico
facility: Puerto Rico-AIDS CRS (5401)
Study officials:
affiliation: Department of Orofacial Sciences, UCSF AIDS OHARA
name: Caroline Shiboski, DDS, MPH, PhD
role: STUDY_CHAIR
affiliation: UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital
name: Mark A. Jacobson, MD
role: STUDY_CHAIR
References:
citation: Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.