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 - Full Text View

Purpose

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	Intervention	Phase
HIV Infections Cervix, Dysplasia	Drug: Fluorouracil	Phase III

MedlinePlus related topics:

AIDS Cancer

Drug Information available for:

Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Parallel Assignment, Safety Study

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

158

Detailed 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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000758

Show 35 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Hoffmann-La Roche

Investigators


Study Chair:	Maiman M

Study Chair:	Watts DH

More Information

Publications:

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

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)

Study ID Numbers:	ACTG 200
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000758
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Fluorouracil

Cervix Dysplasia

Cervix Diseases

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Precancerous Conditions

Acquired Immunodeficiency Syndrome

Uterine Diseases

AIDS-Related Complex

Immunologic Deficiency Syndromes

Carcinoma

Cervical Intraepithelial Neoplasia

Genital Diseases, Female

Virus Diseases

Uterine Cervical Diseases

HIV Infections

Fluorouracil

Cervical intraepithelial neoplasia

Carcinoma in Situ

Sexually Transmitted Diseases

Uterine Cervical Dysplasia

Retroviridae Infections

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites

RNA Virus Infections

Slow Virus Diseases

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Immunologic Factors

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Infection

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Therapeutic Uses

Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000758