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

5. desember 2013 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

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

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AIDS Clinical Trials Group

Samarbeidspartnere

National Institute of Allergy and Infectious Diseases (NIAID)

Etterforskere

  • 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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. mai 2013

Studiet fullført (Faktiske)

1. mai 2013

Datoer for studieregistrering

Først innsendt

7. desember 2009

Først innsendt som oppfylte QC-kriteriene

7. desember 2009

Først lagt ut (Anslag)

9. desember 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. desember 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. desember 2013

Sist bekreftet

1. desember 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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