A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
13 Years
N/A
Female
HIV Infections, Cervix, Dysplasia
Trial Information
A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
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.]
Inclusion 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Principal Investigator
William Robinson
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
ACTG 293
NCT ID:
NCT00001073
Start Date:
Completion Date:
March 2001
Related Keywords:
- HIV Infections
- Cervix, Dysplasia
- Acquired Immunodeficiency Syndrome
- AIDS-Related Complex
- Cervix Dysplasia
- Cervix Diseases
- Isotretinoin
- Cervical Intraepithelial Neoplasia
- Cervix Neoplasms
- Keratolytic Agents
- HIV Infections
- Acquired Immunodeficiency Syndrome
Name | Location |
|---|---|
| Alabama Therapeutics CRS | Birmingham, Alabama 35294 |
| UCLA CARE Center CRS | Los Angeles, California 90095 |
| USC CRS | Los Angeles, California 90033 |
| Ucsd, Avrc Crs | San Diego, California |
| Ucsf Aids Crs | San Francisco, California |
| Santa Clara Valley Med. Ctr. | San Jose, California 95128 |
| San Mateo County AIDS Program | San Mateo, California 94305 |
| Howard University Hosp., Div. of Infectious Diseases, ACTU | Washington, District of Columbia 20059 |
| Univ. of Miami AIDS CRS | Miami, Florida 33136 |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu, Hawaii 96816 |
| Northwestern University CRS | Chicago, Illinois 60611 |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago, Illinois 60612 |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis, Indiana 46202 |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans, Louisiana 70112 |
| Tulane/LSU Maternal/Child CRS | New Orleans, Louisiana 70112 |
| Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
| Bmc Actg Crs | Boston, Massachusetts 02118 |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis, Missouri 63112 |
| Washington U CRS | St. Louis, Missouri |
| Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha, Nebraska |
| NJ Med. School CRS | Newark, New Jersey |
| SUNY - Buffalo, Erie County Medical Ctr. | Buffalo, New York 14215 |
| NY Univ. HIV/AIDS CRS | New York, New York 10016 |
| Memorial Sloan-Kettering Cancer Ctr. | New York, New York 10021 |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York, New York 10003 |
| Univ. of Rochester ACTG CRS | Rochester, New York 14642 |
| Unc Aids Crs | Chapel Hill, North Carolina 27599 |
| Duke Univ. Med. Ctr. Adult CRS | Durham, North Carolina 27710 |
| The Ohio State Univ. AIDS CRS | Columbus, Ohio 43210 |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |
| University of Washington AIDS CRS | Seattle, Washington 98122 |
| Usc La Nichd Crs | Los Angeles, California 90033 |
| Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago, Illinois 60637 |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse, New York 13210 |
| UW School of Medicine - CHRMC | Seattle, Washington 98122 |
| South Florida CDC Ft Lauderdale NICHD CRS | Fort Lauderdale, Florida |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville, Florida |
