A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals
I. Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients
with high-grade anal squamous intraepithelial lesions.
II. Determine clinical response and histologic/cytologic regression in patients treated with
III. Determine immune response in patients treated with this drug. IV. Determine the effect
of this drug on HIV viral load and CD4 level in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive SGN-00101 subcutaneously once on weeks 0, 4, and 8. Treatment continues in
the absence of disease progression or unacceptable toxicity.
Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6
patients experience dose-limiting toxicity.
Patients are followed at 1, 4, and 10 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Joel Palefsky, MD
University of California, San Francisco
United States: Food and Drug Administration
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