Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
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