Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors

Completed · Phase 3

Conditions studied: HIV Infections, Cervix, Dysplasia

In brief

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.

Key facts

Study ID

NCT00001073

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

150

Expected to finish

2001-03-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 D.C., 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 — St Louis, Missouri, United States
• Washington U CRS — St 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

Full record on ClinicalTrials.gov

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