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
NCT ID: NCT00000758
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
1998-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PARALLEL
PREVENTION
Interventions
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Fluorouracil
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Maiman M
Role: STUDY_CHAIR
Watts DH
Role: STUDY_CHAIR
Locations
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Usc La Nichd Crs
Los Angeles, California, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Northwestern University CRS
Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
NJ Med. School CRS
Newark, New Jersey, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
UW School of Medicine - CHRMC
Seattle, Washington, United States
Puerto Rico-AIDS CRS
San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. doi: 10.1016/s0889-8588(05)70391-9.
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)
Other Identifiers
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11176
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 200
Identifier Type: -
Identifier Source: org_study_id