title: 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.
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.
authors.affiliation: Mt. Zion Medical Center and San Francisco General Hospital, University of California, USA.
authors.forename: J
authors.initials: J
authors.lastname: Lalezari
authors.forename: T
authors.initials: T
authors.lastname: Schacker
authors.forename: J
authors.initials: J
authors.lastname: Feinberg
authors.forename: J
authors.initials: J
authors.lastname: Gathe
authors.forename: S
authors.initials: S
authors.lastname: Lee
authors.forename: T
authors.initials: T
authors.lastname: Cheung
authors.forename: F
authors.initials: F
authors.lastname: Kramer
authors.forename: H
authors.initials: H
authors.lastname: Kessler
authors.forename: L
authors.initials: L
authors.lastname: Corey
authors.forename: W L
authors.initials: WL
authors.lastname: Drew
authors.forename: J
authors.initials: J
authors.lastname: Boggs
authors.forename: B
authors.initials: B
authors.lastname: McGuire
authors.forename: H S
authors.initials: HS
authors.lastname: Jaffe
authors.forename: S
authors.initials: S
authors.lastname: Safrin
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000212:Acyclovir / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D000818:Animals; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002478:Cells, Cultured; D002522:Chlorocebus aethiops; D000077404:Cidofovir; D003596:Cytosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D005260:Female; D017245:Foscarnet / Q000494:pharmacology; D005782:Gels; D006561:Herpes Simplex / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009061:Mouth Mucosa / Q000821:virology; D063065:Organophosphonates; D009943:Organophosphorus Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018139:Simplexvirus / Q000254:growth & development; D014709:Vero Cells
chemical_list: D000998:Antiviral Agents; D005782:Gels; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D017245:Foscarnet; D003596:Cytosine; D000077404:Cidofovir; D000212:Acyclovir