Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 me...
Gender
FEMALE
Eligibility 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.
Trial Officials
William Robinson
Study Chair
Mitchell Maiman
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
San Mateo, California, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Newark, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
San Juan, , Puerto Rico
Mbeya, , Tanzania
San Juan, , Puerto Rico
Los Angeles, California, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
Syracuse, New York, United States
Seattle, Washington, United States
Fort Lauderdale, Florida, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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