Search / Trial NCT00000764

Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Interferon Alfa 2a Acquired Immunodeficiency Syndrome Aids Related Complex Anus Neoplasms Papillomavirus, Human Papovaviridae Infections Tumor Virus Infections Isotretinoin

Description

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 (o...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • PCP prophylaxis (required for patients with CD4 count < 200 cells/mm3).
  • Chemoprophylaxis for candidiasis and herpes simplex.
  • Metronidazole for up to 14 days.
  • Erythropoietin.
  • Patients must have:
  • HIV seropositivity.
  • NO active opportunistic infection requiring treatment with prohibited drugs.
  • Phase I - Current grade 1 AIN (i.e., low grade SIL) OR treated or untreated grade 2 or 3 AIN (i.e., high grade SIL).
  • Phase II - Prior histologically confirmed grade 2 or 3 AIN / high grade SIL, with ablative therapy within the past 30-90 days.
  • Capability of complying with study protocol.
  • NOTE:
  • The terms condyloma, grade 1 AIN, and low grade SIL are interchangeable. Grade 2 or 3 AIN is interchangeable with high grade SIL.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active medical problems for which the patient is undergoing evaluations or for which prohibited therapy is required.
  • Other active malignancies requiring systemic therapy.
  • Significant symptomatic cardiac disease.
  • NOTE:
  • Patients with malignancies being managed with local therapy (e.g., Kaposi's sarcoma, basal cell carcinoma) may enroll at the discretion of the site investigator.
  • Concurrent Medication:
  • Excluded:
  • G-CSF (filgrastim).
  • Myelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis).
  • Corticosteroids.
  • Biologic response modifiers.
  • Cytotoxic chemotherapy.
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy.
  • 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:
  • G-CSF (filgrastim).
  • Myelosuppressive antibiotics (except co-trimoxazole for PCP prophylaxis).
  • Corticosteroids.
  • Biologic response modifiers.
  • Cytotoxic chemotherapy.
  • Prior Treatment:
  • Excluded within 20 days prior to study entry:
  • Radiation therapy.
  • Excluded within 14 days prior to study entry:
  • Transfusion.
  • Active substance abuse or illegal drug use (alcohol consumption is strongly discouraged).

Attachments

readout_NCT00000764_2024-03-02.pdf

4.5 MB

NCT00000764_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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