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NCT01029249 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01029249
Other study ID # ACTG A5272
Secondary ID 1U01AI068636
Status Completed
Phase N/A
First received December 7, 2009
Last updated December 5, 2013
Start date January 2010
Est. completion date May 2013

Study information
Verified date December 2013
Source AIDS Clinical Trials Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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).

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 information / eligibility
Status Completed
Enrollment 500
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Puerto Rico-AIDS CRS (5401) San Juan
United States The Ponce de Leon Ctr. CRS (5802) Atlanta Georgia
United States IHV Baltimore Treatment CRS (4651) Baltimore Maryland
United States Alabama Therapeutics CRS (5801) Birmingham Alabama
United States Beth Israel Deaconess Medical Center ACTG CRS (103) Boston Maryland
United States Massachusetts General Hospital ACTG CRS (101) Boston Massachusetts
United States Cooper Univ. Hosp. CRS (31476) Camden New Jersey
United States University of North Carolina AIDS CRS Chapel Hill North Carolina
United States Northwestern University CRS (2701) Chicago Illinois
United States Rush University Medical Center (2702) Chicago Illinois
United States University of Cincinnati CRS Cincinnati Ohio
United States Case CRS (2501) Cleveland Ohio
United States MetroHealth CRS (2503) Cleveland Ohio
United States The Ohio State University AIDS CRS (2301) Colombus Ohio
United States Henry Ford Hosp. CRS (31472) Detroit Michigan
United States Duke Univ. Med. Ctr. Adult CRS (1601) Durham North Carolina
United States Moses H. Cone Memorial Hosp. CRS Greensboro North Carolina
United States Houston AIDS Research Team CRS (31473) Houston Texas
United States UCLA CARE Center CRS (601) Los Angeles California
United States University of Southern California CRS (1201) Los Angeles California
United States University of Miami AIDS CRS (901) Miami Florida
United States Vanderbilt Therapeutics CRS (3652) Nashville Tennessee
United States Cornell CRS (7804) New York New York
United States HIV Prevention and Treatment New York New York
United States New Jersey Medical School- Adult Clinical Research Ctr. CRS Newark New Jersey
United States Stanford Palo Alto California
United States Hospital of the University of Pennsylvania CRS (6201) Philadelphia Pennsylvania
United States The Miriam Hospital ACTG CRS (2951) Providence Rhode Island
United States Virginia Commonwealth Univ. Medical Ctr. CRS (31475) Richmond Virginia
United States AIDS Care CRS (1108) Rochester New York
United States University of Rochester ACTG CRS (1101) Rochester New York
United States Ucsd, Avrc Crs (701) San Diego California
United States University of California San Francisco AIDS CRS (801) San Francisco California
United States University of Washington AIDS CRS (1401) Seattle Washington
United States Washington University CRS (2101) St. Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary Persistence of same type HPV DNA shedding from pre-entry/baseline visits to Week 16 and 24 visits Measured at Weeks 16 and 24 No
Secondary Clinical diagnosis (presence versus absence) of oral warts Measured at Weeks 16 and 24 No
Secondary HPV shedding at one of the pre-HAART visits Measured at one of the pre-entry visits No
Secondary CD4 count change (compared to baseline) Measured at Weeks 4, 16, and 24 No
Secondary Plasma HIV-1 RNA suppression Measured at Weeks 4, 16, and 24 No
Secondary 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 No
Secondary Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam Measured at baseline and Weeks 16, 24, and 48 No
Secondary Number of oral sex partners in the last month Measured at baseline and Weeks 24 and 48 No
Secondary Number of oral sex partners in the last 6 months Measured at baseline and Weeks 24 and 48 No
Secondary Absolute CD8 count (obtained from A5257 study data) Measured at Weeks 0 and 24 in the A5257 study No
Secondary Absolute CD4 count (obtained from A5257 study data) Measured at Weeks 0, 24, and 48 in the A5257 study No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR Measured during the A5272 study or obtained from stored specimens No
Secondary 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 No
Secondary Salivary total lgA and anti-HPV lgA and S-lgA titers Measured during the A5272 study or obtained from stored specimens No
Secondary Serum total anti-HPV lgG titers Measured during the A5272 study or obtained from stored specimens No
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