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

5. december 2013 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
ACTG A5257 participants
Participants in this study will also be enrolled in ACTG A5257.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Type-specific oral HPV DNA shedding (presence versus absence)
Tidsramme: 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
Tidsramme: Measured at Weeks 16 and 24
Measured at Weeks 16 and 24

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AIDS Clinical Trials Group

Samarbejdspartnere

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. maj 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

7. december 2009

Først indsendt, der opfyldte QC-kriterier

7. december 2009

Først opslået (Skøn)

9. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACTG A5272
  • 1U01AI068636 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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