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

19. november 2013 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering

160

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

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

13 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

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

Hvordan er studiet utformet?

Samarbeidspartnere og etterforskere

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbeidspartnere

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

Etterforskere

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

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. november 2000

Studiet fullført (Faktiske)

1. august 2005

Datoer for studieregistrering

Først innsendt

3. november 2000

Først innsendt som oppfylte QC-kriteriene

30. august 2001

Først lagt ut (Anslag)

31. august 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. november 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. november 2013

Sist bekreftet

1. november 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A5029
  • AACTG A5029
  • ACTG A5029

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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