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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
N/A
Not Enrolling
Female
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:

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.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Maiman M

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 200

NCT ID:

NCT00000758

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

Name

Location

Univ. of Miami AIDS CRSMiami, Florida  33136
Northwestern University CRSChicago, Illinois  60611
Cook County Hosp. CORE Ctr.Chicago, Illinois  60612
Tulane/LSU Maternal/Child CRSNew Orleans, Louisiana  70112
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
NJ Med. School CRSNewark, New Jersey  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Univ. of Rochester ACTG CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Usc La Nichd CrsLos Angeles, California  90033
Univ. of Chicago - Dept. of Peds., Div. of Infectious DiseaseChicago, Illinois  60637
Children's Hospital of Michigan NICHD CRSDetroit, Michigan  48201
Bronx-Lebanon Hosp. IMPAACT CRSBronx, New York  10457
SUNY Upstate Med. Univ., Dept. of Peds.Syracuse, New York  13210
UW School of Medicine - CHRMCSeattle, Washington  98122