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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Cervix, Dysplasia

Intervention: Isotretinoin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
William Robinson, Study Chair
Mitchell Maiman, Study Chair


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.

Clinical Details

Official title: A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women

Study design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

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, 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.]


Minimum age: 13 Years. Maximum age: N/A. Gender(s): Female.


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


- 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.

Locations and Contacts

Puerto Rico-AIDS CRS, San Juan, Puerto Rico

San Juan City Hosp. PR NICHD CRS, San Juan, Puerto Rico

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS, Mbeya, Tanzania

Alabama Therapeutics CRS, Birmingham, Alabama 35294, United States

UCLA CARE Center CRS, Los Angeles, California 90095, United States

USC CRS, Los Angeles, California 90033, United States

Usc La Nichd Crs, Los Angeles, California, United States

Ucsd, Avrc Crs, San Diego, California 92103, United States

Ucsf Aids Crs, San Francisco, California, United States

Santa Clara Valley Med. Ctr., San Jose, California 95128, United States

San Mateo County AIDS Program, San Mateo, California 94305, United States

Howard University Hosp., Div. of Infectious Diseases, ACTU, Washington, District of Columbia 20059, 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 33136, United States

Univ. of Hawaii at Manoa, Leahi Hosp., Honolulu, Hawaii 96816, United States

Northwestern University CRS, Chicago, Illinois 60611, United States

Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois 60612, 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 46202, United States

Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU, New Orleans, Louisiana 70112, United States

Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana 70112, United States

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland 21287, United States

Bmc Actg Crs, Boston, Massachusetts 02118, United States

St. Louis ConnectCare, Infectious Diseases Clinic, St Louis, Missouri 63112, United States

Washington U CRS, St. Louis, Missouri, United States

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr., Omaha, Nebraska 68198, United States

NJ Med. School CRS, Newark, New Jersey, United States

SUNY - Buffalo, Erie County Medical Ctr., Buffalo, New York 14215, United States

Beth Israel Med. Ctr. (Mt. Sinai), New York, New York 10003, United States

Memorial Sloan-Kettering Cancer Ctr., New York, New York 10021, United States

NY Univ. HIV/AIDS CRS, New York, New York 10016, United States

Univ. of Rochester ACTG CRS, Rochester, New York 14642, United States

SUNY Upstate Med. Univ., Dept. of Peds., Syracuse, New York, United States

Unc Aids Crs, Chapel Hill, North Carolina 275997215, United States

Duke Univ. Med. Ctr. Adult CRS, Durham, North Carolina 27710, United States

The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States

Hosp. of the Univ. of Pennsylvania CRS, Philadelphia, Pennsylvania 19104, United States

University of Washington AIDS CRS, Seattle, Washington 98104, United States

UW School of Medicine - CHRMC, Seattle, Washington, United States

Additional Information

Related publications:

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

Last updated: March 30, 2012

Page last updated: August 23, 2015

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