We updated the design of this site on September 25th. Learn more.
Show more
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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000758
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
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.
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
March 17, 2014
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00000758 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 3
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
  • HIV Infections
  • Cervix, Dysplasia
Drug: Fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
April 1998
Not Provided

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.
Sexes Eligible for Study: Female
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00000758
ACTG 200
11176 ( Registry Identifier: DAIDS ES Registry Number )
Not Provided
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Hoffmann-La Roche
Study Chair: Maiman M
Study Chair: Watts DH
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP