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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
HIV Infections; Cervix, Dysplasia	Drug: Isotretinoin	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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	150 participants
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 :	March 2001

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted:	August 31, 2001
Last Update Posted:	April 2, 2012
Last Verified:	March 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