Search / Trial NCT00001073

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

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Cervix Dysplasia Cervix Diseases Isotretinoin Cervical Intraepithelial Neoplasia Cervix Neoplasms Keratolytic Agents

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 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.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

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