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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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 Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects typically obtain the finest healthcare available for their 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 condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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
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
For Condition: HIV Infections,Cervix, Dysplasia
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry 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.
Total Enrollment: 158
Location and Contact Information:
Overall Study Official:
MaimanM, Study Chair,
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City, New York, 10021
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Univ of Washington
Seattle, Washington, 981224304
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Additional Information:
Study ID Numbers: ACTG 200;
Study Start Date:
Record last reviewed: April 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000758
Other Hiv Infections Studies:
1. Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
2. Transfusion Infections Pediatric Prospective Study (TRIPPS)
3. Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
4. A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients with AIDS or AIDS-Related Syndromes
5. A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
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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
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