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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

  Show 35 Study Locations
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014