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

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