SPRUANCE SL, TYRING S, BLEAZARD C, VANDERSTRATEN M, SMITH M, MENG T; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 263.
Univ. of Utah, Salt Lake City, UT
BACKGROUND: R-848 is a topically-active immune response modifier that selectively induces cytokines, including IFN-alpha and IL-12. R-848 decreased recurrences in a guinea pig model of genital herpes.METHODS: To determine if topical application of R-848 to genital herpes lesions decreases recurrences, immune competent adults with a history of >/= 6 recurrences/yr were sequentially randomized to a 3 week treatment of R-848 gel or vehicle (2:1) in dosing cohorts of 12. Study drug was applied to lesion(s) =24 hours from onset. Six dosing regimens were planned. Patients were then observed for 6 months.RESULTS: Fifty-two patients were randomized. Three of 12 patients (1 vehicle, 2 R-848) had dose-limiting local adverse events in the second cohort, requiring dose deescalation of the third cohort. A total of 4 cohorts were enrolled; the other 3 regimens were well tolerated. Forty seven patients entered observation. Kaplan Meier estimate of median time to first recurrence was 169 days for R-848 patients (combined) compared to 57 for vehicle patients (p<0.01). The proportion without a recurrence during observation was 6% (1/18) for vehicle and 32% (11/34) for R-848 patients (p<0.05).CONCLUSIONS: Topical R-848 treatment of genital herpes lesions delayed the recurrence of herpes genitalis in this study. Assays of herpes-specific cellular immunity are in progress. Larger trials are warranted to evaluate R-848 for managing recurrent herpes.KEYWORDS: Clinical trial; Genital herpes; Immune response modifier
Publication Types:
Keywords:
- Administration, Topical
- Adult
- Clinical Trials as Topic
- Cytokines
- Double-Blind Method
- Female
- Herpes Genitalis
- Humans
- Imidazoles
- Interferon-alpha
- Male
- R 848
- Recurrence
Other ID:
UI: 102246944
From Meeting Abstracts