- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01029249
Examining the Incidence of Oral Human Papillomavirus (HPV) Shedding and Oral Warts After Beginning HAART in HIV-Infected Adults
Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-2050
- Alabama Therapeutics CRS (5801)
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA CARE Center CRS (601)
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Los Angeles, California, Estados Unidos, 90033
- University of Southern California CRS (1201)
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Palo Alto, California, Estados Unidos, 94304
- Stanford
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San Diego, California, Estados Unidos, 92103
- Ucsd, Avrc Crs (701)
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San Francisco, California, Estados Unidos, 94110
- University of California San Francisco AIDS CRS (801)
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Florida
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Miami, Florida, Estados Unidos, 33139
- University of Miami AIDS CRS (901)
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- The Ponce de Leon Ctr. CRS (5802)
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University CRS (2701)
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center (2702)
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- IHV Baltimore Treatment CRS (4651)
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Boston, Maryland, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center ACTG CRS (103)
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital ACTG CRS (101)
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hosp. CRS (31472)
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University CRS (2101)
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cooper Univ. Hosp. CRS (31476)
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Newark, New Jersey, Estados Unidos, 07103
- New Jersey Medical School- Adult Clinical Research Ctr. CRS
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New York
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New York, New York, Estados Unidos, 10011
- Cornell CRS (7804)
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New York, New York, Estados Unidos, 10032
- HIV Prevention and Treatment
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Rochester, New York, Estados Unidos, 14642
- University of Rochester ACTG CRS (1101)
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Rochester, New York, Estados Unidos, 14607
- AIDS Care CRS (1108)
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- University of North Carolina AIDS CRS
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Durham, North Carolina, Estados Unidos, 27710
- Duke Univ. Med. Ctr. Adult CRS (1601)
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Greensboro, North Carolina, Estados Unidos, 27401
- Moses H. Cone Memorial Hosp. CRS
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267
- University of Cincinnati CRS
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Cleveland, Ohio, Estados Unidos, 44106
- Case CRS (2501)
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Cleveland, Ohio, Estados Unidos, 44109
- MetroHealth CRS (2503)
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Colombus, Ohio, Estados Unidos, 43210
- The Ohio State University AIDS CRS (2301)
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Hospital of the University of Pennsylvania CRS (6201)
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02906
- The Miriam Hospital ACTG CRS (2951)
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt Therapeutics CRS (3652)
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Texas
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Houston, Texas, Estados Unidos, 77030
- Houston AIDS Research Team CRS (31473)
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Virginia
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Richmond, Virginia, Estados Unidos, 23219
- Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
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Washington
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Seattle, Washington, Estados Unidos, 98104
- University of Washington AIDS CRS (1401)
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San Juan, Porto Rico, 00931
- Puerto Rico-AIDS CRS (5401)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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ACTG A5257 participants
Participants in this study will also be enrolled in ACTG A5257.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Type-specific oral HPV DNA shedding (presence versus absence)
Prazo: Measured at baseline (measured at pre-entry and entry into A5257) and at Weeks 16 and 24
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Measured at baseline (measured at pre-entry and entry into A5257) and at Weeks 16 and 24
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Persistence of same type HPV DNA shedding from pre-entry/baseline visits to Week 16 and 24 visits
Prazo: Measured at Weeks 16 and 24
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Measured at Weeks 16 and 24
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Clinical diagnosis (presence versus absence) of oral warts
Prazo: Measured at Weeks 16 and 24
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Measured at Weeks 16 and 24
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HPV shedding at one of the pre-HAART visits
Prazo: Measured at one of the pre-entry visits
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Measured at one of the pre-entry visits
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CD4 count change (compared to baseline)
Prazo: Measured at Weeks 4, 16, and 24
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Measured at Weeks 4, 16, and 24
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Plasma HIV-1 RNA suppression
Prazo: Measured at Weeks 4, 16, and 24
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Measured at Weeks 4, 16, and 24
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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
Prazo: Measured at Weeks 16 or 24
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Measured at Weeks 16 or 24
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Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam
Prazo: Measured at baseline and Weeks 16, 24, and 48
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Measured at baseline and Weeks 16, 24, and 48
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Number of oral sex partners in the last month
Prazo: Measured at baseline and Weeks 24 and 48
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Measured at baseline and Weeks 24 and 48
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Number of oral sex partners in the last 6 months
Prazo: Measured at baseline and Weeks 24 and 48
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Measured at baseline and Weeks 24 and 48
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Absolute CD8 count (obtained from A5257 study data)
Prazo: Measured at Weeks 0 and 24 in the A5257 study
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Measured at Weeks 0 and 24 in the A5257 study
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Absolute CD4 count (obtained from A5257 study data)
Prazo: Measured at Weeks 0, 24, and 48 in the A5257 study
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Measured at Weeks 0, 24, and 48 in the A5257 study
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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)
Prazo: Measured during the A5272 study or obtained from stored specimens
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Measured during the A5272 study or obtained from stored specimens
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Percentage and absolute number of CD8 cells that are IFN, tumor necrosis factor (TNF), TGF+, or CD107+ after HPV peptide stimulation measured from PBMCs
Prazo: Measured during the A5272 study or obtained from stored specimens
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Measured during the A5272 study or obtained from stored specimens
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Percentage and absolute number of CD4 cells that are regulatory T cells (CD4+/CD25+/CD127low) measured from PBMCs
Prazo: Measured during the A5272 study or obtained from stored specimens
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Measured during the A5272 study or obtained from stored specimens
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Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR
Prazo: Measured during the A5272 study or obtained from stored specimens
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Measured during the A5272 study or obtained from stored specimens
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Persistence of HPV DNA of a specific type in throat wash specimens over the time course of the study
Prazo: Measured during the A5272 study or obtained from stored specimens
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Measured during the A5272 study or obtained from stored specimens
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Salivary total lgA and anti-HPV lgA and S-lgA titers
Prazo: Measured during the A5272 study or obtained from stored specimens
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Measured during the A5272 study or obtained from stored specimens
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Serum total anti-HPV lgG titers
Prazo: Measured during the A5272 study or obtained from stored specimens
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Measured during the A5272 study or obtained from stored specimens
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Caroline Shiboski, DDS, MPH, PhD, Department of Orofacial Sciences, UCSF AIDS OHARA
- Cadeira de estudo: Mark A. Jacobson, MD, UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Infecções por HIV
Outros números de identificação do estudo
- ACTG A5272
- 1U01AI068636 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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