Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
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| ClinicalTrials.gov Identifier: NCT00001073 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : April 2, 2012
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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 |
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 (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 |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001073
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| Study Chair: | William Robinson | ||
| Study Chair: | Mitchell Maiman |
Publications:
| 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 Key Record Dates |
| Last Update Posted: | April 2, 2012 |
| Last Verified: | March 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Acquired Immunodeficiency Syndrome AIDS-Related Complex Cervix Dysplasia Cervix Diseases |
Isotretinoin Cervical Intraepithelial Neoplasia Cervix Neoplasms Keratolytic Agents |
Additional relevant MeSH terms:
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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 |