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

December 5, 2013 updated by: AIDS Clinical Trials Group

Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
ACTG A5257 participants
Participants in this study will also be enrolled in ACTG A5257.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Time Frame: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical diagnosis (presence versus absence) of oral warts
Time Frame: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24
HPV shedding at one of the pre-HAART visits
Time Frame: Measured at one of the pre-entry visits
Measured at one of the pre-entry visits
CD4 count change (compared to baseline)
Time Frame: Measured at Weeks 4, 16, and 24
Measured at Weeks 4, 16, and 24
Plasma HIV-1 RNA suppression
Time Frame: Measured at Weeks 4, 16, and 24
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
Time Frame: Measured at Weeks 16 or 24
Measured at Weeks 16 or 24
Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam
Time Frame: Measured at baseline and Weeks 16, 24, and 48
Measured at baseline and Weeks 16, 24, and 48
Number of oral sex partners in the last month
Time Frame: Measured at baseline and Weeks 24 and 48
Measured at baseline and Weeks 24 and 48
Number of oral sex partners in the last 6 months
Time Frame: Measured at baseline and Weeks 24 and 48
Measured at baseline and Weeks 24 and 48
Absolute CD8 count (obtained from A5257 study data)
Time Frame: Measured at Weeks 0 and 24 in the A5257 study
Measured at Weeks 0 and 24 in the A5257 study
Absolute CD4 count (obtained from A5257 study data)
Time Frame: Measured at Weeks 0, 24, and 48 in the A5257 study
Measured at Weeks 0, 24, and 48 in the A5257 study
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
Measured during the A5272 study or obtained from stored specimens
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
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
Time Frame: Measured during the A5272 study or obtained from stored specimens
Measured during the A5272 study or obtained from stored specimens
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
Measured during the A5272 study or obtained from stored specimens
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
Measured during the A5272 study or obtained from stored specimens
Salivary total lgA and anti-HPV lgA and S-lgA titers
Time Frame: Measured during the A5272 study or obtained from stored specimens
Measured during the A5272 study or obtained from stored specimens
Serum total anti-HPV lgG titers
Time Frame: Measured during the A5272 study or obtained from stored specimens
Measured during the A5272 study or obtained from stored specimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AIDS Clinical Trials Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACTG A5272
  • 1U01AI068636 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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