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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000758
Other study ID # ACTG 200
Secondary ID 11176
Status Completed
Phase Phase 3
First received
Last updated
Est. completion date April 1998

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 158
Est. completion date April 1998
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 13 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Fluorouracil


Locations

Country Name City State
Puerto Rico Puerto Rico-AIDS CRS San Juan
Puerto Rico San Juan City Hosp. PR NICHD CRS San Juan
United States Johns Hopkins Adult AIDS CRS Baltimore Maryland
United States Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts
United States Bmc Actg Crs Boston Massachusetts
United States Bronx-Lebanon Hosp. IMPAACT CRS Bronx New York
United States SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York
United States Unc Aids Crs Chapel Hill North Carolina
United States Cook County Hosp. CORE Ctr. Chicago Illinois
United States Northwestern University CRS Chicago Illinois
United States Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease Chicago Illinois
United States Univ. of Cincinnati CRS Cincinnati Ohio
United States Children's Hospital of Michigan NICHD CRS Detroit Michigan
United States Usc La Nichd Crs Los Angeles California
United States Univ. of Miami AIDS CRS Miami Florida
United States Tulane/LSU Maternal/Child CRS New Orleans Louisiana
United States Memorial Sloan-Kettering Cancer Ctr. New York New York
United States NJ Med. School CRS Newark New Jersey
United States Univ. of Rochester ACTG CRS Rochester New York
United States UW School of Medicine - CHRMC Seattle Washington
United States SUNY Upstate Med. Univ., Dept. of Peds. Syracuse New York

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

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)

Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. Review. — View Citation

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