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

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.]

Study Type

Interventional

Enrollment

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
        • San Juan City Hosp. PR NICHD CRS
      • San Juan, Puerto Rico
        • Puerto Rico-AIDS CRS
  • Tanzania
      • Mbeya, Tanzania
        • Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alabama Therapeutics CRS
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Center CRS
      • Los Angeles, California, United States, 90033
        • USC CRS
      • Los Angeles, California, United States
        • Usc La Nichd Crs
      • San Diego, California, United States, 92103
        • Ucsd, Avrc Crs
      • San Francisco, California, United States
        • Ucsf Aids Crs
      • San Jose, California, United States, 95128
        • Santa Clara Valley Med. Ctr.
      • San Mateo, California, United States, 94305
        • San Mateo County AIDS Program
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard University Hosp., Div. of Infectious Diseases, ACTU
    • Florida
      • Fort Lauderdale, Florida, United States
        • South Florida CDC Ft Lauderdale NICHD CRS
      • Jacksonville, Florida, United States
        • Univ. of Florida Jacksonville NICHD CRS
      • Miami, Florida, United States, 33136
        • Univ. of Miami AIDS CRS
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
      • Chicago, Illinois, United States, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
      • Chicago, Illinois, United States
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane/LSU Maternal/Child CRS
      • New Orleans, Louisiana, United States, 70112
        • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Adult AIDS CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Bmc Actg Crs
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington U CRS
      • Saint Louis, Missouri, United States, 63112
        • St. Louis ConnectCare, Infectious Diseases Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
    • New Jersey
      • Newark, New Jersey, United States
        • NJ Med. School CRS
    • New York
      • Buffalo, New York, United States, 14215
        • SUNY - Buffalo, Erie County Medical Ctr.
      • New York, New York, United States, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, United States, 10003
        • Beth Israel Med. Ctr. (Mt. Sinai)
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Ctr.
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
      • Syracuse, New York, United States
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Unc Aids Crs
      • Durham, North Carolina, United States, 27710
        • Duke Univ. Med. Ctr. Adult CRS
    • Ohio
      • Columbus, Ohio, United States
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington AIDS CRS
      • Seattle, Washington, United States
        • UW School of Medicine - CHRMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

March 1, 2001

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 293
  • 11269 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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