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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

Phase 3
13 Years
Not Enrolling
HIV Infections, Cervix, Dysplasia

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Trial Information

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

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- 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:


- 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:


- Fluorouracil (systemic or topical) within 3 months prior to study entry.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Principal Investigator

Maiman M

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 200



Start Date:

Completion Date:

April 1998

Related Keywords:

  • HIV Infections
  • Cervix, Dysplasia
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Fluorouracil
  • Cervix Dysplasia
  • Cervix Diseases
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Hyperplasia



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