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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
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

NCT00000758

CompletedPhase 3

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: HIV Infections, Cervix, Dysplasia

Interventions: Fluorouracil

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: FEMALE

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (21)
  • Los Angeles, California, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Newark, New Jersey, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Syracuse, New York, United States
  • The Bronx, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Seattle, Washington, United States
  • San Juan, Puerto Rico
  • San Juan, Puerto Rico