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
2 other identifiers
interventional
158
2 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
April 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Usc La Nichd Crs
Los Angeles, California, 90033, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60637, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201, United States
NJ Med. School CRS
Newark, New Jersey, 07103, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27599, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267, United States
UW School of Medicine - CHRMC
Seattle, Washington, 98122, United States
Puerto Rico-AIDS CRS
San Juan, 00936, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Related Publications (2)
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.
PMID: 8880203BACKGROUNDMaiman 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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maiman M
- STUDY CHAIR
Watts DH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
April 1, 1998
Last Updated
November 4, 2021
Record last verified: 2021-10