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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000758

Collaborator

Hoffmann-La Roche (Industry)

158

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Cervix, Dysplasia	Drug: Fluorouracil	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Prevention

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

Actual Study Completion Date :

Apr 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Usc La Nichd Crs	Los Angeles	California	United States	90033
2	Univ. of Miami AIDS CRS	Miami	Florida	United States	33136
3	Northwestern University CRS	Chicago	Illinois	United States	60611
4	Cook County Hosp. CORE Ctr.	Chicago	Illinois	United States	60612
5	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois	United States	60637
6	Tulane/LSU Maternal/Child CRS	New Orleans	Louisiana	United States	70112
7	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland	United States	21287
8	Bmc Actg Crs	Boston	Massachusetts	United States	02118
9	Beth Israel Deaconess Med. Ctr., ACTG CRS	Boston	Massachusetts	United States	02215
10	Children's Hospital of Michigan NICHD CRS	Detroit	Michigan	United States	48201
11	NJ Med. School CRS	Newark	New Jersey	United States	07103
12	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York	United States	10457
13	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York	United States	14215
14	Memorial Sloan-Kettering Cancer Ctr.	New York	New York	United States	10021
15	Univ. of Rochester ACTG CRS	Rochester	New York	United States	14642
16	SUNY Upstate Med. Univ., Dept. of Peds.	Syracuse	New York	United States	13210
17	Unc Aids Crs	Chapel Hill	North Carolina	United States	27599
18	Univ. of Cincinnati CRS	Cincinnati	Ohio	United States	45267
19	UW School of Medicine - CHRMC	Seattle	Washington	United States	98122
20	Puerto Rico-AIDS CRS	San Juan		Puerto Rico	00936
21	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico	00936