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

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.

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

Study design: Treatment, Efficacy Study

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.

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.

Univ of Puerto Rico, San Juan 009365067, Puerto Rico

Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Univ of California / San Diego Treatment Ctr, San Diego, California 921036325, United States

San Francisco Gen Hosp, San Francisco, California 941102859, United States

UCLA CARE Ctr, Los Angeles, California 90095, United States

Univ of Southern California / LA County USC Med Ctr, Los Angeles, California 900331079, United States

San Mateo AIDS Program / Stanford Univ, Stanford, California 943055107, United States

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California 951282699, United States

Willow Clinic, Menlo Park, California 94025, United States

Howard Univ, Washington, District of Columbia 20059, United States

Univ of Miami School of Medicine, Miami, Florida 331361013, United States

Univ of Hawaii, Honolulu, Hawaii 96816, United States

Northwestern Univ Med School, Chicago, Illinois 60611, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Cook County Hosp, Chicago, Illinois 60612, United States

Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States

Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana 46202, United States

Charity Hosp / Tulane Univ Med School, New Orleans, Louisiana 70112, United States

Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States

Johns Hopkins Hosp, Baltimore, Maryland 21287, United States

Boston Med Ctr, Boston, Massachusetts 02118, United States

St Louis Regional Hosp / St Louis Regional Med Ctr, St. Louis, Missouri 63112, United States

Univ of Nebraska Med Ctr, Omaha, Nebraska 681985130, United States

St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr, New York, New York 10021, United States

Univ of Rochester Medical Center, Rochester, New York 14642, United States

Mem Sloan - Kettering Cancer Ctr, New York, New York 10021, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Saint Clare's Hosp and Health Ctr, New York, New York 10019, United States

Univ of North Carolina, Chapel Hill, North Carolina 275997215, United States

Duke Univ Med Ctr, Durham, North Carolina 27710, United States

Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania 19104, United States

Julio Arroyo, West Columbia, South Carolina 29169, United States

Univ of Texas Galveston, Galveston, Texas 775550435, United States

Univ of Washington, Seattle, Washington 98104, United States

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: June 23, 2005