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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001073
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date April 2, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00001073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Official Title  ICMJE A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Cervix, Dysplasia
Intervention  ICMJE Drug: Isotretinoin
Study Arms  ICMJE Not Provided
Publications * Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   Tanzania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00001073
Other Study ID Numbers  ICMJE ACTG 293
11269 ( Registry Identifier: DAIDS ES Registry Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: William Robinson
Study Chair: Mitchell Maiman
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP