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.
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.
Lalezari
J
J
Mt. Zion Medical Center and San Francisco General Hospital, University of California, USA.
Schacker
T
T
Feinberg
J
J
Gathe
J
J
Lee
S
S
Cheung
T
T
Kramer
F
F
Kessler
H
H
Corey
L
L
Drew
W L
WL
Boggs
J
J
McGuire
B
B
Jaffe
H S
HS
Safrin
S
S
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
D000998:Antiviral Agents; D005782:Gels; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D017245:Foscarnet; D003596:Cytosine; D000077404:Cidofovir; D000212:Acyclovir