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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01029249
First received: December 7, 2009
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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).


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical diagnosis (presence versus absence) of oral warts [ Time Frame: Measured at Weeks 16 and 24 ] [ Designated as safety issue: No ]
  • HPV shedding at one of the pre-HAART visits [ Time Frame: Measured at one of the pre-entry visits ] [ Designated as safety issue: No ]
  • CD4 count change (compared to baseline) [ Time Frame: Measured at Weeks 4, 16, and 24 ] [ Designated as safety issue: No ]
  • Plasma HIV-1 RNA suppression [ Time Frame: Measured at Weeks 4, 16, and 24 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Number of oral sex partners in the last month [ Time Frame: Measured at baseline and Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Number of oral sex partners in the last 6 months [ Time Frame: Measured at baseline and Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Absolute CD8 count (obtained from A5257 study data) [ Time Frame: Measured at Weeks 0 and 24 in the A5257 study ] [ Designated as safety issue: No ]
  • Absolute CD4 count (obtained from A5257 study data) [ Time Frame: Measured at Weeks 0, 24, and 48 in the A5257 study ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Serum total anti-HPV lgG titers [ Time Frame: Measured during the A5272 study or obtained from stored specimens ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Saliva and blood will be collected from participants.


Enrollment: 500
Study Start Date: January 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ACTG A5257 participants
Participants in this study will also be enrolled in ACTG A5257.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in this study will also be enrolled in ACTG A5257.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029249

  Hide Study Locations
Locations
United States, Alabama
Alabama Therapeutics CRS (5801)
Birmingham, Alabama, United States, 35294-2050
United States, California
UCLA CARE Center CRS (601)
Los Angeles, California, United States, 90095
University of Southern California CRS (1201)
Los Angeles, California, United States, 90033
Stanford
Palo Alto, California, United States, 94304
Ucsd, Avrc Crs (701)
San Diego, California, United States, 92103
University of California San Francisco AIDS CRS (801)
San Francisco, California, United States, 94110
United States, Florida
University of Miami AIDS CRS (901)
Miami, Florida, United States, 33139
United States, Georgia
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, United States, 30308
United States, Illinois
Rush University Medical Center (2702)
Chicago, Illinois, United States, 60612
Northwestern University CRS (2701)
Chicago, Illinois, United States, 60611
United States, Maryland
IHV Baltimore Treatment CRS (4651)
Baltimore, Maryland, United States, 21201
Beth Israel Deaconess Medical Center ACTG CRS (103)
Boston, Maryland, United States, 02215
United States, Massachusetts
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hosp. CRS (31472)
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University CRS (2101)
St. Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Univ. Hosp. CRS (31476)
Camden, New Jersey, United States, 08103
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, United States, 07103
United States, New York
Cornell CRS (7804)
New York, New York, United States, 10011
HIV Prevention and Treatment
New York, New York, United States, 10032
University of Rochester ACTG CRS (1101)
Rochester, New York, United States, 14642
AIDS Care CRS (1108)
Rochester, New York, United States, 14607
United States, North Carolina
University of North Carolina AIDS CRS
Chapel Hill, North Carolina, United States, 27514
Duke Univ. Med. Ctr. Adult CRS (1601)
Durham, North Carolina, United States, 27710
Moses H. Cone Memorial Hosp. CRS
Greensboro, North Carolina, United States, 27401
United States, Ohio
University of Cincinnati CRS
Cincinnati, Ohio, United States, 45267
MetroHealth CRS (2503)
Cleveland, Ohio, United States, 44109
Case CRS (2501)
Cleveland, Ohio, United States, 44106
The Ohio State University AIDS CRS (2301)
Colombus, Ohio, United States, 43210
United States, Pennsylvania
Hospital of the University of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
The Miriam Hospital ACTG CRS (2951)
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Therapeutics CRS (3652)
Nashville, Tennessee, United States, 37232
United States, Texas
Houston AIDS Research Team CRS (31473)
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
Richmond, Virginia, United States, 23219
United States, Washington
University of Washington AIDS CRS (1401)
Seattle, Washington, United States, 98104
Puerto Rico
Puerto Rico-AIDS CRS (5401)
San Juan, Puerto Rico, 00931
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Caroline Shiboski, DDS, MPH, PhD Department of Orofacial Sciences, UCSF AIDS OHARA
Study Chair: Mark A. Jacobson, MD UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01029249     History of Changes
Other Study ID Numbers: ACTG A5272, 1U01AI068636
Study First Received: December 7, 2009
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 24, 2014