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	Treatment or Intervention	Phase
HIV Infections Cervix, Dysplasia	Drug: Fluorouracil	Phase III

Further Study Details: 

Expected Total Enrollment:  158

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Female

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.

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

Study chairs or principal investigators

Maiman M,  Study Chair
Watts DH,  Study Chair

Study ID Numbers:  ACTG 200
Record last reviewed:  April 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000758
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08