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A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: Hoffmann-La Roche
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000758
  Purpose

To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function.

Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.


Condition Intervention Phase
HIV Infections
Cervix, Dysplasia
Drug: Fluorouracil
Phase III

Study Type: Interventional
Study Design: Prevention, Parallel Assignment, Safety Study
Official Title: A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 158
Detailed Description:

Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.

Patients are randomized to receive either intravaginal fluorouracil or no treatment (observation only). Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months. Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretrovirals (AZT, ddI, ddC) and immunomodulators (interferon and interleukin).
  • Prophylaxis or treatment for opportunistic infections.
  • Vaginal antifungal agents or other indicated vaginal medications (although not permitted on day of fluorouracil application).
  • Contraceptives.
  • Acyclovir (prophylaxis or treatment) in patients with a history of primary or recurrent genital herpes.

Patients must have:

  • HIV infection.
  • Prior cervical dysplasia (grade II or III cervical intraepithelial neoplasia) successfully treated with an ablative procedure within the past 12 weeks.
  • Patients less than 18 years of age must have consent of parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Untreated or persistent vaginal or vulvar dysplasia.
  • Colposcopy or biopsy inconclusive or positive for dysplasia.
  • Active genital ulcerative disease such as syphilitic chancre or herpes ulcer.
  • Adenocarcinoma in situ.

Concurrent Medication:

Excluded:

  • Cytotoxic chemotherapy for malignancy.
  • High-dose steroids (> 10 mg/day prednisone or its steroid equivalent).

Patients with the following prior conditions are excluded:

  • Malignancy requiring cytotoxic chemotherapy within the 3 months prior to study entry.
  • Prior hysterectomy.
  • History of allergic reaction or severe hypersensitivity to fluorouracil.

Prior Medication:

Excluded:

  • Fluorouracil (systemic or topical) within 3 months prior to study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000758

  Hide Study Locations
Locations
United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Illinois
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, United States, 60611
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Cook County Hosp
Chicago, Illinois, United States, 60612
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, Michigan
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
United States, New York
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States, 11203
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, United States, 10021
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, United States, 10465
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
Mid - Hudson Care Ctr
Albany, New York, United States, 122083479
Saint Clare's Hosp and Health Ctr
New York, New York, United States, 10019
Adirondack Med Ctr at Saranac Lake
Albany, New York, United States, 122083479
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States, 122083479
Harlem Hosp Ctr
New York, New York, United States, 10037
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, United States, 10467
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Univ of Washington
Seattle, Washington, United States, 981224304
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Maiman M
Study Chair: Watts DH
  More Information

Publications:
Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. Review.
Maiman M, Watts DH, Andersen J. A phase three randomized trial of topical vaginal 5-fluorouracil maintenance therapy versus observation after standard treatment for high grade cervical dysplasia in HIV-infected women: ACTG 200. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:155 (abstract no 466)

Study ID Numbers: ACTG 200
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000758     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Fluorouracil
Cervix Dysplasia
Cervix Diseases

Additional relevant MeSH terms:
Antimetabolites
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Genital Diseases, Female
Uterine Cervical Diseases
Therapeutic Uses
Carcinoma in Situ
Retroviridae Infections
RNA Virus Infections
Neoplasms by Histologic Type
Immune System Diseases
Acquired Immunodeficiency Syndrome
Uterine Diseases
Immunosuppressive Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Cervical Intraepithelial Neoplasia
Carcinoma
Virus Diseases
Neoplasms
HIV Infections
Fluorouracil
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 27, 2009