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Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors Clinical research trials and Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors clinical trial. Human subjects often obtain the finest healthcare possible for their Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors  Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
For Condition: HIV Infections,Cervix, Dysplasia
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous. Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected women are at a greater risk, and often their tumors become cancerous more quickly than those in HIV-negative women. Isotretinoin may be able to prevent this from happening. However, since these tumors tend to disappear over time, many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects. This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves.
Details: Cervical neoplasia is frequently seen in HIV-infected women, apparently resulting from immunosuppression and common risk factors, including sexual behavior patterns. In HIV seronegative women, progression of preinvasive neoplasia is relatively slow, and up to 40 percent of low grade squamous intraepithelial lesions (grade I CIN/HPV-associated changes) regress to a normal appearance over time. Many clinicians have opted not to treat CIN I/HPV-associated changes due to this high spontaneous regression rate. Currently, retinoids, principally isotretinoin, are the most consistently effective medical therapy for CIN/HPV-associated changes, but use of isotretinoin in HIV-infected patients has not been extensively documented. (AS PER AMENDMENT 6/10/97) Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months, with 12 additional months of follow-up. [AS PER AMENDMENT 7/23/99: Follow-up time has been decreased to 9 months from the last patient enrolled.]
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are an HIV-positive female. - Are at least 13 years old. (Need consent of parent or guardian if under 18.) - Have cervical tumors, as determined by a biopsy performed by a doctor. - Agree to use both condoms and the pill during the study. Exclusion Criteria You will not be eligible for this study if you: - Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months. - Have had a hysterectomy (uterus removed) within the past 4 months. - Are taking tetracycline or Vitamin A. - Have taken certain medications. (Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.) - Are pregnant.
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
WilliamRobinson, Study Chair,
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Univ of Washington
Seattle, Washington, 98104
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City, New York, 10021
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Willow Clinic
Menlo Park, California, 94025
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Additional Information:
Study ID Numbers: ACTG 293;
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001073
Other Cervix, Dysplasia Studies:
1. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
2. 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
Related Studies:
Other Cervix, Dysplasia Clinical Trials
Other California Clinical Trials
Other Menlo Park Clinical Trials
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
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