A randomized, double-blind, placebo-controlled trial of cidofovir gel for the treatment of acyclovir-unresponsive mucocutaneous herpes simplex virus infection in patients with AIDS

Jacob Lalezari, Tim Schacker, Judith Feinberg, Joseph Gathe, Sabina Lee, Tony Cheung, Francoise Kramer, Harold Kessler, Lawrence Corey, W. Lawrence Drew, John Boggs, Brian McGuire, Howard S. Jaffe, Sharon Safrin

Research output: Contribution to journalArticlepeer-review

132 Scopus citations

Abstract

The safety and efficacy of cidofovir gel for treatment of acyclovir- unresponsive herpes simplex virus infections in AIDS patients was evaluated in a randomized, double-blind, multicenter trial. Cidofovir (0.3% or 1%) or placebo gel was applied once daily for 5 days. Ten of 20 cidofovir-treated and none of 10 placebo-treated patients had complete healing or >50% decreased area (P = .008); 30% of cidofovir-treated patients versus 0 placebo recipients had complete healing (P = .031). Viral shedding ceased in 13 (87%) of 15 cidofovir-treated and 0 of 9 placebo-treated patients (P = .00004). For cidofovir-treated patients, median time to complete or good response was 21 days, and median time to negative viral culture was 2 days (P = .025, P = .0001, respectively). Median lesion area decreases were 58% for cidofovir- treated versus 0 for placebo-treated patients (P = .005), and mean pain score changes were -1.84 versus -0.34 (P = .042). Application site reactions occurred in 25% of cidofovir-treated and 20% of placebo-treated patients; none was dose-limiting. Cidofovir therapy provided significant benefits in lesion healing, virologic effect, and pain reduction.

Original languageEnglish (US)
Pages (from-to)892-898
Number of pages7
JournalJournal of Infectious Diseases
Volume176
Issue number4
DOIs
StatePublished - 1997

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