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

5 décembre 2013 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
ACTG A5257 participants
Participants in this study will also be enrolled in ACTG A5257.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Type-specific oral HPV DNA shedding (presence versus absence)
Délai: 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
Délai: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24

Mesures de résultats secondaires

Mesure des résultats
Délai
Clinical diagnosis (presence versus absence) of oral warts
Délai: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24
HPV shedding at one of the pre-HAART visits
Délai: Measured at one of the pre-entry visits
Measured at one of the pre-entry visits
CD4 count change (compared to baseline)
Délai: Measured at Weeks 4, 16, and 24
Measured at Weeks 4, 16, and 24
Plasma HIV-1 RNA suppression
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Measured at baseline and Weeks 24 and 48
Measured at baseline and Weeks 24 and 48
Absolute CD8 count (obtained from A5257 study data)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Measured during the A5272 study or obtained from stored specimens
Measured during the A5272 study or obtained from stored specimens

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AIDS Clinical Trials Group

Collaborateurs

National Institute of Allergy and Infectious Diseases (NIAID)

Les enquêteurs

  • Chaise d'étude: Caroline Shiboski, DDS, MPH, PhD, Department of Orofacial Sciences, UCSF AIDS OHARA
  • Chaise d'étude: Mark A. Jacobson, MD, UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 mai 2013

Achèvement de l'étude (Réel)

1 mai 2013

Dates d'inscription aux études

Première soumission

7 décembre 2009

Première soumission répondant aux critères de contrôle qualité

7 décembre 2009

Première publication (Estimation)

9 décembre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

6 décembre 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 décembre 2013

Dernière vérification

1 décembre 2013

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ACTG A5272
  • 1U01AI068636 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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