PMID- 19214122
OWN - NLM
STAT- MEDLINE
DCOM- 20090414
LR  - 20211020
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 50
IP  - 4
DP  - 2009 Apr 1
TI  - A randomized controlled trial of the safety of candidate microbicide SPL7013 gel 
      when applied to the penis.
PG  - 375-80
LID - 10.1097/QAI.0b013e318198a7e6 [doi]
AB  - OBJECTIVES: To determine the safety of the candidate vaginal microbicide SPL7013 
      gel (VivaGel) when applied to the penis. METHODS: A randomized, double-blind, 
      placebo-controlled study. Thirty-six healthy men (18 circumcised, 18 
      uncircumcised) were randomized in a 2:1 ratio and treated with 3% SPL7013 gel (n 
      = 24) or placebo gel (n = 12), applied once daily for 7 days. Genital toxicity 
      was determined by interview, diary, and examination. RESULTS: There were 10 
      genital adverse events (AEs) in 6 men (25%) receiving SPL7013 gel and 5 genital 
      AEs in 4 men (33%) receiving the placebo that were possibly or probably related 
      to the study product (difference of -8%, 95% confidence interval: -40% to 23%, P 
      = 0.70). The most common genital AEs were genital pruritus and application site 
      erythema. All genital AEs were mild (grade 1), and all but 1 in the placebo group 
      were transient. Analysis of vital signs, nongenital AEs, and laboratory results 
      indicated no safety or tolerability issues with SPL7013 gel, irrespective of 
      circumcision status. There was no detectable absorption of SPL7013 into the 
      plasma. CONCLUSIONS: Three percent SPL7013 gel was safe and well tolerated, and 
      comparable with placebo, when administered to the penis of both circumcised and 
      uncircumcised men once daily for 7 days, with no evidence of systemic absorption 
      or toxicity.
FAU - Chen, Marcus Y
AU  - Chen MY
AD  - Melbourne Sexual Health Centre, The Alfred Hospital, and School of Population 
      Health, University of Melbourne, Melbourne, Australia. mchen@mshc.org.au
FAU - Millwood, Iona Y
AU  - Millwood IY
FAU - Wand, Handan
AU  - Wand H
FAU - Poynten, Mary
AU  - Poynten M
FAU - Law, Matthew
AU  - Law M
FAU - Kaldor, John M
AU  - Kaldor JM
FAU - Wesselingh, Steve
AU  - Wesselingh S
FAU - Price, Clare F
AU  - Price CF
FAU - Clark, Laura J
AU  - Clark LJ
FAU - Paull, Jeremy R A
AU  - Paull JR
FAU - Fairley, Christopher K
AU  - Fairley CK
LA  - eng
GR  - U19 AI060598-03/AI/NIAID NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Dendrimers)
RN  - 0 (Gels)
RN  - 25104-18-1 (Polylysine)
RN  - F8H3J9KSY9 (astodrimer)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Infective Agents/administration & dosage/*adverse effects
MH  - Dendrimers
MH  - Double-Blind Method
MH  - Female
MH  - Gels
MH  - HIV Infections/*prevention & control
MH  - Humans
MH  - Male
MH  - Medication Adherence
MH  - Middle Aged
MH  - Penis
MH  - Polylysine/administration & dosage/*adverse effects
PMC - PMC2680448
MID - NIHMS94892
EDAT- 2009/02/14 09:00
MHDA- 2009/04/15 09:00
PMCR- 2010/04/01
CRDT- 2009/02/14 09:00
PHST- 2009/02/14 09:00 [entrez]
PHST- 2009/02/14 09:00 [pubmed]
PHST- 2009/04/15 09:00 [medline]
PHST- 2010/04/01 00:00 [pmc-release]
AID - 10.1097/QAI.0b013e318198a7e6 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2009 Apr 1;50(4):375-80. doi: 
      10.1097/QAI.0b013e318198a7e6.