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

5 de diciembre de 2013 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

500

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

Cohortes e Intervenciones

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Type-specific oral HPV DNA shedding (presence versus absence)
Periodo de tiempo: 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
Periodo de tiempo: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AIDS Clinical Trials Group

Colaboradores

National Institute of Allergy and Infectious Diseases (NIAID)

Investigadores

  • Silla de estudio: Caroline Shiboski, DDS, MPH, PhD, Department of Orofacial Sciences, UCSF AIDS OHARA
  • Silla de estudio: Mark A. Jacobson, MD, UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2010

Finalización primaria (Actual)

1 de mayo de 2013

Finalización del estudio (Actual)

1 de mayo de 2013

Fechas de registro del estudio

Enviado por primera vez

7 de diciembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

7 de diciembre de 2009

Publicado por primera vez (Estimar)

9 de diciembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de diciembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

5 de diciembre de 2013

Última verificación

1 de diciembre de 2013

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACTG A5272
  • 1U01AI068636 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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