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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000764 |
PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection.
SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels.
Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.
Condition | Intervention | Phase |
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HIV Infections Anus Neoplasms |
Drug: Isotretinoin Drug: Interferon alfa-2a |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Efficacy Study |
Official Title: | Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection. |
Estimated Enrollment: | 98 |
Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.
In the Phase I portion of the study, 20 patients per site each receive isotretinoin in escalating doses. If a patient experiences grade 2 or worse toxicity (or grade 3 or worse hypertriglyceridemia), dose is reduced to the previously tolerated dose for the remainder of the 6 week period. Patients are then reassessed for anal neoplasia; those with no progression and no grade 2 or worse toxicity receive an additional 6 weeks of isotretinoin in combination with interferon alfa-2a. For Phase II of the study, a separate group of patients who have undergone ablative therapy are randomized to one of three arms (26 patients/arm): isotretinoin alone at the dose tolerated by at least 60 percent of patients in Phase I; isotretinoin plus interferon alfa-2a; or observation only. Treatment continues for 48 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Phase II - Prior histologically confirmed grade 2 or 3 AIN / high grade SIL, with ablative therapy within the past 30-90 days.
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
NOTE:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
History of ventricular arrhythmias or myocardial infarction.
Prior Medication:
Excluded within 20 days prior to study entry:
Prior Treatment:
Excluded within 20 days prior to study entry:
Excluded within 14 days prior to study entry:
Active substance abuse or illegal drug use (alcohol consumption is strongly discouraged).
United States, California | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 981224304 |
Study Chair: | Palefsky JM | |
Study Chair: | Northfelt DW | |
Study Chair: | Kaplan LD | |
Study Chair: | Critchlow C |
Study ID Numbers: | ACTG 216 |
Study First Received: | November 2, 1999 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00000764 |
Health Authority: | United States: Federal Government |
Interferon Alfa-2a Acquired Immunodeficiency Syndrome AIDS-Related Complex Anus Neoplasms |
Papillomavirus, Human Papovaviridae Infections Tumor Virus Infections Isotretinoin |
Sexually Transmitted Diseases, Viral Rectal Neoplasms Gastrointestinal Diseases Rectal Diseases Isotretinoin Neoplasm Metastasis Rectal cancer Retroviridae Infections Interferon-alpha Digestive System Neoplasms Skin Diseases Interferons Acquired Immunodeficiency Syndrome AIDS-Related Complex Intestinal Diseases |
Immunologic Deficiency Syndromes Intestinal Neoplasms Rectal neoplasm Virus Diseases Skin Diseases, Infectious Warts Digestive System Diseases HIV Infections Sexually Transmitted Diseases Gastrointestinal Neoplasms Papillomavirus Infections DNA Virus Infections Anal cancer Interferon Alfa-2a Anus Neoplasms |
Anti-Infective Agents Communicable Diseases RNA Virus Infections Slow Virus Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Tumor Virus Infections Infection Angiogenesis Inhibitors |
Antiviral Agents Pharmacologic Actions Skin Diseases, Viral Neoplasms Neoplasms by Site Therapeutic Uses Lentivirus Infections Growth Inhibitors Angiogenesis Modulating Agents Dermatologic Agents Anus Diseases |