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Ensayos clínicos

Ensayos clínicos

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

Patrocinador(es) del estudio: AIDS Clinical Trials Group
Números de identificación: NCT01029249, ACTG A5272
  • En curso, con inscripciones cerradas

Propósito del estudio

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).

Afección:
Infecciones por el VIH

Detalles del estudio

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.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.

Criterios de inclusión

    :
    • Meet inclusion criteria for and be enrolled in ACTG A5257
    • Ability and willingness of participant or legal guardian/representative to provide
    informed consent

Criterios de exclusión

    :
    • 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

Centros de estudio/contactos

Alabama

    Alabama Therapeutics CRS (5801), Birmingham, Alabama, 35294-2050, United States

California

    UCLA CARE Center CRS (601), Los Angeles, California, 90095, United States

    University of Southern California CRS (1201), Los Angeles, California, 90033, United States

    Stanford, Palo Alto, California, 94304, United States

    Ucsd, Avrc Crs (701), San Diego, California, 92103, United States

    University of California San Francisco AIDS CRS (801), San Francisco, California, 94110, United States

Florida

    University of Miami AIDS CRS (901), Miami, Florida, 33139, United States

Georgia

    The Ponce de Leon Ctr. CRS (5802), Atlanta, Georgia, 30308, United States

Illinois

    Rush University Medical Center (2702), Chicago, Illinois, 60612, United States

    Northwestern University CRS (2701), Chicago, Illinois, 60611, United States

Maryland

    IHV Baltimore Treatment CRS (4651), Baltimore, Maryland, 21201, United States

    Beth Israel Deaconess Medical Center ACTG CRS (103), Boston, Maryland, 02215, United States

Massachusetts

    Massachusetts General Hospital ACTG CRS (101), Boston, Massachusetts, 02114, United States

Michigan

    Henry Ford Hosp. CRS (31472), Detroit, Michigan, 48202, United States

Missouri

    Washington University CRS (2101), St. Louis, Missouri, 63110, United States

New Jersey

    Cooper Univ. Hosp. CRS (31476), Camden, New Jersey, 08103, United States

    New Jersey Medical School- Adult Clinical Research Ctr. CRS, Newark, New Jersey, 07103, United States

New York

    Cornell CRS (7804), New York, New York, 10011, United States

    HIV Prevention and Treatment, New York, New York, 10032, United States

    University of Rochester ACTG CRS (1101), Rochester, New York, 14642, United States

    AIDS Care CRS (1108), Rochester, New York, 14607, United States

North Carolina

    University of North Carolina AIDS CRS, Chapel Hill, North Carolina, 27514, United States

    Duke Univ. Med. Ctr. Adult CRS (1601), Durham, North Carolina, 27710, United States

    Moses H. Cone Memorial Hosp. CRS, Greensboro, North Carolina, 27401, United States

Ohio

    University of Cincinnati CRS, Cincinnati, Ohio, 45267, United States

    MetroHealth CRS (2503), Cleveland, Ohio, 44109, United States

    Case CRS (2501), Cleveland, Ohio, 44106, United States

    The Ohio State University AIDS CRS (2301), Colombus, Ohio, 43210, United States

Pennsylvania

    Hospital of the University of Pennsylvania CRS (6201), Philadelphia, Pennsylvania, 19104, United States

Rhode Island

    The Miriam Hospital ACTG CRS (2951), Providence, Rhode Island, 02906, United States

Tennessee

    Vanderbilt Therapeutics CRS (3652), Nashville, Tennessee, 37232, United States

Texas

    Houston AIDS Research Team CRS (31473), Houston, Texas, 77030, United States

Virginia

    Virginia Commonwealth Univ. Medical Ctr. CRS (31475), Richmond, Virginia, 23219, United States

Washington

    University of Washington AIDS CRS (1401), Seattle, Washington, 98104, United States

    Puerto Rico-AIDS CRS (5401), San Juan, Washington, 00931, Puerto Rico

Actualizado: 17 de diciembre del 2009

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