|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | 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 |
| 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
Hide Study Locations| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Illinois | |
| Children's Mem Hosp Family Cln / Northwestern Univ Med Schl | |
| Chicago, Illinois, United States, 60611 | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Cook County Hosp | |
| Chicago, Illinois, United States, 60612 | |
| Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 606371470 | |
| United States, Louisiana | |
| Tulane Univ / Charity Hosp of New Orleans | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Med Ctr | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Children's Hosp of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| United States, New York | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| King's County Hosp Ctr / Pediatrics | |
| Brooklyn, New York, United States, 11203 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |
| Syracuse, New York, United States, 13210 | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10457 | |
| Mid - Hudson Care Ctr | |
| Albany, New York, United States, 122083479 | |
| Saint Clare's Hosp and Health Ctr | |
| New York, New York, United States, 10019 | |
| Adirondack Med Ctr at Saranac Lake | |
| Albany, New York, United States, 122083479 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 112032098 | |
| Albany Med College / Division of HIV Medicine A158 | |
| Albany, New York, United States, 122083479 | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Washington | |
| Children's Hospital & Medical Center / Seattle ACTU | |
| Seattle, Washington, United States, 981050371 | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224304 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Maiman M | |
| Study Chair: | Watts DH |
More Information
| Study ID Numbers: | ACTG 200 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000758 History of Changes |
| Health Authority: | United States: Federal Government |
|
Acquired Immunodeficiency Syndrome AIDS-Related Complex Fluorouracil Cervix Dysplasia Cervix Diseases |
|
Antimetabolites Sexually Transmitted Diseases, Viral Slow Virus Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Physiological Effects of Drugs Infection Genital Diseases, Female Uterine Cervical Diseases Therapeutic Uses Carcinoma in Situ Retroviridae Infections |
RNA Virus Infections Neoplasms by Histologic Type Immune System Diseases Acquired Immunodeficiency Syndrome Uterine Diseases Immunosuppressive Agents Pharmacologic Actions Immunologic Deficiency Syndromes Cervical Intraepithelial Neoplasia Carcinoma Virus Diseases Neoplasms HIV Infections Fluorouracil Sexually Transmitted Diseases |