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The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women

19. november 2013 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART

The purpose of this study is to see how often human papillomavirus (HPV) occurs in HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV drugs will affect HPV in women.

HIV infection increases the risk of getting HPV infection. Findings suggest that HIV infection as well as a weakened immune system may increase the chances of getting HPV. Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting HPV. This study is important because it may provide important information to help manage a woman's health and to determine a woman's risk for developing problems with the cervix (outer end of the uterus).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

HIV infection is a significant risk factor for human HPV infection and the development of HPV-associated lesions in the female genital tract. Findings suggest that HIV infection and/or HIV-related immunosuppression increases a woman's susceptibility to HPV infection or alters the natural history of preexisting HPV infection. Treatment with HAART has been shown to result in significant increases in CD4+ cell counts and "partial reconstitution" of the immune system. It is not known whether treatment of HIV infection with potent antiretroviral regimens could affect the persistence of HPV infection and progression of cervical dysplasia. This study is important for HIV-infected women because of the implications for gynecologic management and determination of cervical disease risk.

At baseline, Weeks 24 and 48, and then every 48 weeks until study completion, women undergo pelvic examination and cervical specimens collection by the following methods: 1) Sno-strip; 2) cervicovaginal lavage; 3) cervical brush method; and 4) Pap smear. A colposcopy is required for any woman who has an abnormal Pap smear reading unless the abnormal Pap smear is thought to be due to an intercurrent infection. A cervical biopsy is strongly recommended in the event of an abnormal colposcopy. Blood is collected for HPV antibody testing, viral load, and CD4 measures.

Undersøgelsestype

Observationel

Tilmelding

160

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
        • Univ of Alabama at Birmingham
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, Forenede Stater, 900276016
        • Children's Hosp of Los Angeles/UCLA Med Ctr
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, Forenede Stater, 900331079
        • Univ of Southern California / LA County USC Med Ctr
      • San Diego, California, Forenede Stater, 92103
        • Univ of California, San Diego
      • San Francisco, California, Forenede Stater, 941104206
        • University of California San Francisco
      • Stanford, California, Forenede Stater, 94305-5107
        • San Mateo County AIDS Program
      • Stanford, California, Forenede Stater, 94305-5107
        • Stanford Univ
      • Stanford, California, Forenede Stater, 94305-5107
        • Willow Clinic
    • Colorado
      • Denver, Colorado, Forenede Stater, 80262-3706
        • Univ of Colorado Health Sciences Ctr, Denver
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20060
        • Howard Univ Hosp
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33311
        • North Broward Hosp District
      • Jacksonville, Florida, Forenede Stater, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, Forenede Stater, 331361013
        • Univ of Miami School of Medicine
      • Miami, Florida, Forenede Stater, 33161
        • Univ of Miami (Pediatric)
      • Miami, Florida, Forenede Stater, 33136
        • Univ of Miami / Jackson Memorial Hosp
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory Univ
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96816
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • The CORE Ctr
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, Forenede Stater, 60608
        • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 462025250
        • Indiana Univ Hosp
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Methodist Hosp of Indiana / Life Care Clinic
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Wishard Hosp
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Hosp
      • Baltimore, Maryland, Forenede Stater, 21201
        • Univ of Maryland, Institute of Human Virology
      • Baltimore, Maryland, Forenede Stater, 20201
        • Univ of Maryland (Pediatric)
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess - West Campus
      • Boston, Massachusetts, Forenede Stater, 02215
        • Brigham and Women's Hosp
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Med Ctr (Pediatric)
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Med Ctr (Harvard)
    • New York
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Med Ctr Adolescent AIDS Program
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med Ctr
      • New York, New York, Forenede Stater, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Forenede Stater, 10032
        • Columbia Presbyterian Med Ctr
      • Rochester, New York, Forenede Stater, 14642
        • Univ of Rochester Medical Center
      • Rochester, New York, Forenede Stater, 14642-001
        • Community Health Network
      • Stony Brook, New York, Forenede Stater, 117948111
        • State Univ of New York at Stony Brook
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 275997215
        • Univ of North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve Univ
      • Cleveland, Ohio, Forenede Stater, 441091998
        • MetroHealth Med Ctr
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Univ of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Brown Univ / Miriam Hosp
      • Providence, Rhode Island, Forenede Stater, 02906
        • Miriam Hosp / Brown Univ
      • Providence, Rhode Island, Forenede Stater, 02906
        • Brown Univ / The Miriam Hosp
    • South Carolina
      • West Columbia, South Carolina, Forenede Stater, 29169
        • Julio Arroyo
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington (Seattle)
  • Puerto Rico
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico / Univ Children's Hosp AIDS

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

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria

Women may be eligible for this study if they:

  • Are HIV-positive.
  • Are at least 13 years of age and menstruating.
  • Are willing to enroll in another drug study.
  • Have written consent of a parent or guardian if under 18 years.
  • This study has been changed to increase enrollment. Women who are starting HAART-based therapy prescribed by a personal physician or participating in an antiretroviral trial are all eligible.
  • Intend to start antiretroviral therapy within 14 days of study entry.

Exclusion Criteria

Women will not be eligible for this study if they:

  • Have been on anti-HIV treatment for more than 14 days.
  • Are abusing drugs or alcohol.
  • Are receiving medication that affects the immune system, fights HPV, or is investigational, except for anti-HIV drugs provided by coenrolling in a Phase II or III trial with approval of a study chair within 30 days of study entry, including but not limited to systemic interferons and interleukins, thalidomide, systemic cidofovir, and HPV vaccines. This study has been changed. The following medications are no longer excluded: thymopentin, hydroxyurea, granulocyte colony-stimulating factor (G-CSF and filgrastim), and GM-CSF (sargramostim).
  • Have cervical cancer or a history of cervical cancer.
  • Have had a hysterectomy (removal of the uterus).
  • Participated in HPV trials at any time.
  • Use imiquimod inside the vagina.
  • Are taking corticosteroid treatment in large doses.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Studiestol: Kathleen Squires
  • Studiestol: Rebecca Clark
  • Studiestol: Kenneth H Fife

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. november 2000

Studieafslutning (Faktiske)

1. august 2005

Datoer for studieregistrering

Først indsendt

3. november 2000

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. november 2013

Sidst verificeret

1. november 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5029
  • AACTG A5029
  • ACTG A5029

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 .

Kliniske forsøg med HIV-infektioner

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Denmark

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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