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

2013年12月5日 更新者：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).

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：队列
  • 时间观点：预期

队列和干预

团体/队列
ACTG A5257 participants
Participants in this study will also be enrolled in ACTG A5257.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Type-specific oral HPV DNA shedding (presence versus absence)
大体时间：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
大体时间：Measured at Weeks 16 and 24
Measured at Weeks 16 and 24

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AIDS Clinical Trials Group

合作者

National Institute of Allergy and Infectious Diseases (NIAID)

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年1月1日

初级完成 (实际的)

2013年5月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2009年12月7日

首先提交符合 QC 标准的

2009年12月7日

首次发布 (估计)

2009年12月9日

研究记录更新

最后更新发布 (估计)

2013年12月6日

上次提交的符合 QC 标准的更新

2013年12月5日

最后验证

2013年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ACTG A5272
  • 1U01AI068636 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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