Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000758
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : April 2, 2012
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 158 participants
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 : April 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000758


Locations
Show Show 21 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Chair: Maiman M
Study Chair: Watts DH
Publications:
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)

Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000758    
Other Study ID Numbers: ACTG 200
11176 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Fluorouracil
Cervix Dysplasia
Cervix Diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Hyperplasia
Pathologic Processes
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs