Penile application of dextrin sulphate gel (Emmelle).
Dextrin sulphate (DS) gel (Emmelle) is under development as a vaginal microbicide. Males who do not use condoms will be exposed to DS gel through sexual intercourse. A randomized, double-blind, placebo-controlled trial was conducted among 16 HIV-positive and 12 HIV-negative men to establish whether 4% DS gel has an acceptable safety profile. Men were asked to apply the gel to the penis once per day for 14 consecutive days and to leave it on for a minimum of 6 h. Results from laboratory evaluations, genital examinations, and adverse events reports showed that 4% DS gel administered topically to the penis was well tolerated when compared with placebo.
Van Damme
Lut
L
Institute of Tropical Medicine, Antwerp, Belgium. lvandamme@conrad.org
Jespers
Vicky
V
Van Dyck
Eddy
E
Chapman
Alan
A
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D003912:Dextrins / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005782:Gels / Q000008:administration & dosage*; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D010314:Partial Thromboplastin Time; D010413:Penis / Q000187:drug effects*; D013918:Thrombin Time
D000891:Anti-Infective Agents, Local; D003912:Dextrins; D005782:Gels; C091377:dextrin 2-sulfate