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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001073
Collaborator
(none)
150
Enrollment
40
Locations
3.8
Patients Per Site

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.]

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
Actual Study Completion Date :
Mar 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Ucsd, Avrc Crs San Diego California United States 92103
    6 Ucsf Aids Crs San Francisco California United States
    7 Santa Clara Valley Med. Ctr. San Jose California United States 95128
    8 San Mateo County AIDS Program San Mateo California United States 94305
    9 Howard University Hosp., Div. of Infectious Diseases, ACTU Washington District of Columbia United States 20059
    10 South Florida CDC Ft Lauderdale NICHD CRS Fort Lauderdale Florida United States
    11 Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida United States
    12 Univ. of Miami AIDS CRS Miami Florida United States 33136
    13 Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu Hawaii United States 96816
    14 Northwestern University CRS Chicago Illinois United States 60611
    15 Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois United States 60612
    16 Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease Chicago Illinois United States
    17 Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis Indiana United States 46202
    18 Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU New Orleans Louisiana United States 70112
    19 Tulane/LSU Maternal/Child CRS New Orleans Louisiana United States 70112
    20 Johns Hopkins Adult AIDS CRS Baltimore Maryland United States 21287
    21 Bmc Actg Crs Boston Massachusetts United States 02118
    22 St. Louis ConnectCare, Infectious Diseases Clinic Saint Louis Missouri United States 63112
    23 Washington U CRS Saint Louis Missouri United States
    24 Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. Omaha Nebraska United States 68198
    25 NJ Med. School CRS Newark New Jersey United States
    26 SUNY - Buffalo, Erie County Medical Ctr. Buffalo New York United States 14215
    27 Beth Israel Med. Ctr. (Mt. Sinai) New York New York United States 10003
    28 NY Univ. HIV/AIDS CRS New York New York United States 10016
    29 Memorial Sloan-Kettering Cancer Ctr. New York New York United States 10021
    30 Univ. of Rochester ACTG CRS Rochester New York United States 14642
    31 SUNY Upstate Med. Univ., Dept. of Peds. Syracuse New York United States
    32 Unc Aids Crs Chapel Hill North Carolina United States 275997215
    33 Duke Univ. Med. Ctr. Adult CRS Durham North Carolina United States 27710
    34 The Ohio State Univ. AIDS CRS Columbus Ohio United States
    35 Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania United States 19104
    36 University of Washington AIDS CRS Seattle Washington United States 98104
    37 UW School of Medicine - CHRMC Seattle Washington United States
    38 Puerto Rico-AIDS CRS San Juan Puerto Rico
    39 San Juan City Hosp. PR NICHD CRS San Juan Puerto Rico
    40 Mbeya Med. Research Program, Mbeya Referral Hosp. CRS Mbeya Tanzania

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: William Robinson,
    • Study Chair: Mitchell Maiman,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00001073
    Other Study ID Numbers:
    • ACTG 293
    • 11269
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Nov 4, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Acquired Immunodeficiency Syndrome
    AIDS-Related Complex
    Cervix Dysplasia
    Cervix Diseases
    Isotretinoin
    Cervical Intraepithelial Neoplasia
    Cervix Neoplasms
    Keratolytic Agents
    Additional relevant MeSH terms:
    HIV Infections
    Isotretinoin

    Study Results

    No Results Posted as of Nov 4, 2021