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
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 10, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
FEMALE
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Newark, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
San Juan, , Puerto Rico
Bronx, New York, United States
San Juan, , Puerto Rico
Los Angeles, California, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Syracuse, New York, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Maiman M
Study Chair
Watts DH
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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