A Phase II Trial of Topical Halofuginone in Patients With HIV Related Kaposi's Sarcoma
I. To determine the tumor response rate of acquired immune deficiency syndrome
(AIDS)-related Kaposi's sarcoma to topical halofuginone (halofuginone hydrobromide) versus
II. To evaluate the safety and tolerability of topical halofuginone and vehicle in patients
with AIDS-related Kaposi's sarcoma.
I. To determine the ability of topical halofuginone to inhibit expression of matrix
metallopeptidase 2 (MMP-2) and Collagen type I in AIDS-related Kaposi's sarcoma.
II. To explore the relationship between baseline cluster of differentiation (CD) 4 and CD8
counts, HIV viral load and human herpesvirus 8 (HHV-8) viral load and response to
III. To characterize the pharmacokinetics of halofuginone.
OUTLINE: Twelve treatable Kaposi's sarcoma lesions are selected on each patient, and these
12 lesions are randomized equally to 1 of 2 treatment arms (6 lesions receive study
treatment and 6 lesions receive placebo); each patient serves as his/her own control.
ARM I: Patients apply topical halofuginone hydrobromide ointment to each of 6 lesions twice
a day for 12 weeks.
ARM II: Patients apply topical placebo ointment to each of 6 lesions twice a day for 12
Patients with stable or responding disease in either or both groups of treated lesions
(halofuginone hydrobromide ointment or placebo ointment) may receive open-label treatment
with topical halofuginone hydrobromide ointment to all 12 lesions for an additional 12 weeks
as above in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 1 month.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
McNemar's chi-square test will be used to compare vehicle control and halofuginone with respect to response rates.
Up to 30 days
AIDS Associated Malignancies Clinical Trials Consortium
United States: Food and Drug Administration
|AIDS - Associated Malignancies Clinical Trials Consortium||Rockville, Maryland 20850|