Spots Global Cancer Trial Database for Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
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Trial Identification
Brief Title: Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Official Title: A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
Study ID: NCT00001073
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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
Minimum Age: 13 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Alabama Therapeutics CRS, Birmingham, Alabama, United States
USC CRS, Los Angeles, California, United States
UCLA CARE Center CRS, Los Angeles, California, United States
Usc La Nichd Crs, Los Angeles, California, United States
Ucsd, Avrc Crs, San Diego, California, United States
Ucsf Aids Crs, San Francisco, California, United States
Santa Clara Valley Med. Ctr., San Jose, California, United States
San Mateo County AIDS Program, San Mateo, California, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU, Washington, District of Columbia, United States
South Florida CDC Ft Lauderdale NICHD CRS, Fort Lauderdale, Florida, United States
Univ. of Florida Jacksonville NICHD CRS, Jacksonville, Florida, United States
Univ. of Miami AIDS CRS, Miami, Florida, United States
Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii, United States
Northwestern University CRS, Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU, New Orleans, Louisiana, United States
Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States
Bmc Actg Crs, Boston, Massachusetts, United States
St. Louis ConnectCare, Infectious Diseases Clinic, Saint Louis, Missouri, United States
Washington U CRS, Saint Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr., Omaha, Nebraska, United States
NJ Med. School CRS, Newark, New Jersey, United States
SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai), New York, New York, United States
NY Univ. HIV/AIDS CRS, New York, New York, United States
Memorial Sloan-Kettering Cancer Ctr., New York, New York, United States
Univ. of Rochester ACTG CRS, Rochester, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds., Syracuse, New York, United States
Unc Aids Crs, Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS, Durham, North Carolina, United States
The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS, Seattle, Washington, United States
UW School of Medicine - CHRMC, Seattle, Washington, United States
Puerto Rico-AIDS CRS, San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS, San Juan, , Puerto Rico
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS, Mbeya, , Tanzania
Contact Details
Name: William Robinson
Affiliation:
Role: STUDY_CHAIR
Name: Mitchell Maiman
Affiliation:
Role: STUDY_CHAIR
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