Status:
COMPLETED
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Cervix, Dysplasia
Eligibility:
FEMALE
13+ years
Phase:
PHASE3
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 fo...
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, progres...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 2001
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00001073
End Date
March 1 2001
Last Update
November 4 2021
Active Locations (40)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
USC CRS
Los Angeles, California, United States, 90033
3
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
4
Usc La Nichd Crs
Los Angeles, California, United States