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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001073
Other study ID # ACTG 293
Secondary ID 11269
Status Completed
Phase Phase 3
First received
Last updated
Est. completion date March 2001

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 medical therapy for CIN/HPV-associated changes, but use of isotretinoin in HIV-infected patients has not been extensively documented. (AS PER AMENDMENT 6/10/97) Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months, with 12 additional months of follow-up. [AS PER AMENDMENT 7/23/99: Follow-up time has been decreased to 9 months from the last patient enrolled.]


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date March 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 13 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Isotretinoin


Locations

Country Name City State
Puerto Rico Puerto Rico-AIDS CRS San Juan
Puerto Rico San Juan City Hosp. PR NICHD CRS San Juan
Tanzania Mbeya Med. Research Program, Mbeya Referral Hosp. CRS Mbeya
United States Johns Hopkins Adult AIDS CRS Baltimore Maryland
United States Alabama Therapeutics CRS Birmingham Alabama
United States Bmc Actg Crs Boston Massachusetts
United States SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York
United States Unc Aids Crs Chapel Hill North Carolina
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 The Ohio State Univ. AIDS CRS Columbus Ohio
United States Duke Univ. Med. Ctr. Adult CRS Durham North Carolina
United States South Florida CDC Ft Lauderdale NICHD CRS Fort Lauderdale Florida
United States Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii
United States Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana
United States Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida
United States UCLA CARE Center CRS Los Angeles California
United States USC CRS Los Angeles California
United States Usc La Nichd Crs Los Angeles California
United States Univ. of Miami AIDS CRS Miami Florida
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 Beth Israel Med. Ctr. (Mt. Sinai) New York New York
United States Memorial Sloan-Kettering Cancer Ctr. New York New York
United States NY Univ. HIV/AIDS CRS New York New York
United States NJ Med. School CRS Newark New Jersey
United States Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. Omaha Nebraska
United States Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania
United States Univ. of Rochester ACTG CRS Rochester New York
United States St. Louis ConnectCare, Infectious Diseases Clinic Saint Louis Missouri
United States Washington U CRS Saint Louis Missouri
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 University of Washington AIDS CRS Seattle Washington
United States UW School of Medicine - CHRMC Seattle Washington
United States SUNY Upstate Med. Univ., Dept. of Peds. Syracuse New York
United States Howard University Hosp., Div. of Infectious Diseases, ACTU Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico,  Tanzania, 

References & Publications (1)

Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. Review. — View Citation

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