HIV Infections Clinical Trial
Official title:
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 number | NCT00000758 |
Other study ID # | ACTG 200 |
Secondary ID | 11176 |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Est. completion date | April 1998 |
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 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Hoffmann-La Roche |
United States, Puerto Rico,
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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