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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000758 |
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study 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 |
| Estimated Enrollment: | 158 |
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 |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations
Show 35 Study Locations| Study Chair: | Maiman M | |
| Study Chair: | Watts DH |
More Information
| ClinicalTrials.gov Identifier: | NCT00000758 History of Changes |
| Other Study ID Numbers: | ACTG 200 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex Fluorouracil Cervix Dysplasia Cervix Diseases |
|
HIV Infections Acquired Immunodeficiency Syndrome Uterine Cervical Dysplasia Cervical Intraepithelial Neoplasia Hyperplasia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Precancerous Conditions |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Pathologic Processes Fluorouracil Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents |