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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00001073

First received: November 2, 1999

Last updated: March 30, 2012

Last verified: March 2012

History of Changes

Purpose

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	Intervention	Phase
HIV Infections Cervix, Dysplasia	Drug: Isotretinoin	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Isotretinoin

Genetic and Rare Diseases Information Center resources: Cervical Intraepithelial Neoplasia

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):


Estimated Enrollment:	150
Study Completion Date:	March 2001

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.]

Eligibility


Ages Eligible for Study:	13 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001073

Show 40 Study Locations

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators


Study Chair:	William Robinson
Study Chair:	Mitchell Maiman

More Information

Publications:

Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. Review.


Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001073 History of Changes
Other Study ID Numbers:	ACTG 293 11269 ( Registry Identifier: DAIDS ES Registry Number )
Study First Received:	November 2, 1999
Last Updated:	March 30, 2012

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 Squamous Intraepithelial Lesions of the Cervix Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes	Immune System Diseases Uterine Cervical Dysplasia Precancerous Conditions Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Isotretinoin Dermatologic Agents

ClinicalTrials.gov processed this record on July 21, 2017

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