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


Phase 3
13 Years
N/A
Not Enrolling
Female
HIV Infections, Cervix, Dysplasia

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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 CRSBirmingham, Alabama  35294
UCLA CARE Center CRSLos Angeles, California  90095
USC CRSLos Angeles, California  90033
Ucsd, Avrc CrsSan Diego, California  
Ucsf Aids CrsSan Francisco, California  
Santa Clara Valley Med. Ctr.San Jose, California  95128
San Mateo County AIDS ProgramSan Mateo, California  94305
Howard University Hosp., Div. of Infectious Diseases, ACTUWashington, District of Columbia  20059
Univ. of Miami AIDS CRSMiami, Florida  33136
Univ. of Hawaii at Manoa, Leahi Hosp.Honolulu, Hawaii  96816
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTUNew Orleans, Louisiana  70112
Tulane/LSU Maternal/Child CRSNew Orleans, Louisiana  70112
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Bmc Actg CrsBoston, Massachusetts  02118
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.Omaha, Nebraska  
NJ Med. School CRSNewark, New Jersey  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
NY Univ. HIV/AIDS CRSNew 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 CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Duke Univ. Med. Ctr. Adult CRSDurham, North Carolina  27710
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210
Hosp. of the Univ. of Pennsylvania CRSPhiladelphia, Pennsylvania  19104
University of Washington AIDS CRSSeattle, Washington  98122
Usc La Nichd CrsLos Angeles, California  90033
Univ. of Chicago - Dept. of Peds., Div. of Infectious DiseaseChicago, Illinois  60637
SUNY Upstate Med. Univ., Dept. of Peds.Syracuse, New York  13210
UW School of Medicine - CHRMCSeattle, Washington  98122
South Florida CDC Ft Lauderdale NICHD CRSFort Lauderdale, Florida  
Univ. of Florida Jacksonville NICHD CRSJacksonville, Florida