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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

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: