PMID- 21311578
OWN - NLM
STAT- MEDLINE
DCOM- 20110802
LR  - 20211020
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 6
IP  - 1
DP  - 2011 Jan 20
TI  - A phase I randomized placebo controlled trial of the safety of 3% SPL7013 Gel 
      (VivaGel(R)) in healthy young women administered twice daily for 14 days.
PG  - e16258
LID - 10.1371/journal.pone.0016258 [doi]
LID - e16258
AB  - OBJECTIVE: To assess the safety of VivaGel(R) used vaginally twice daily for 14 
      days among healthy, sexually-abstinent women, aged 18-24 years in the USA and 
      Kenya. DESIGN: Randomized placebo controlled trial. METHODS: Participants were 
      randomized 2ratio1, VivaGel to placebo. Safety was assessed by comparing 
      genitourinary (GU) adverse events (AEs), colposcopy findings, vaginal 
      lactobacilli and laboratory abnormalities by arm. RESULTS: Fifty-four women were 
      enrolled; 35 in the VivaGel arm and 19 in the placebo arm. Twenty-six (74%) and 
      10 (53%) women reported taking all doses of VivaGel and placebo, respectively. No 
      grade 3 or 4 AEs, or serious AEs occurred. Twenty-five (71%) participants in the 
      VivaGel arm compared to 10 (53%) participants in the placebo arm had at least one 
      grade 1 or 2 GU AE associated with product use (RR = 1.4, 95% CI 0.8-2.2). All 
      seven grade 2 GU AEs associated with product use occurred among four women in the 
      VivaGel arm. Vulvar and cervical erythema, cervical lesions, symptomatic BV, 
      urinary frequency and metrorrhagia were more common in the VivaGel arm than the 
      placebo arm. Twenty-nine (83%) participants in the VivaGel arm had a colposcopic 
      finding compared to 10 (53%) participants in the placebo arm (RR = 1.6, 
      95%CI = 1.0-2.5). Two women in the VivaGel arm prematurely discontinued product 
      use themselves due to a reported GU AE. Persistence of H(2)O(2)-producing and 
      non-producing lactobacilli did not differ by study arm. CONCLUSIONS: GU AEs and 
      colposcopic findings consistent with mild epithelial irritation and inflammation 
      occurred more commonly among women in the VivaGel arm. TRIAL REGISTRATION: 
      ClinicalTrials.gov NCT003311032.
FAU - Cohen, Craig R
AU  - Cohen CR
AD  - Department of Obstetrics, Gynecology and Reproductive Science, University of 
      California San Francisco, San Francisco, California, United States of America. 
      ccohen@globalhealth.ucsf.edu
FAU - Brown, Joelle
AU  - Brown J
FAU - Moscicki, Anna-Barbara
AU  - Moscicki AB
FAU - Bukusi, Elizabeth A
AU  - Bukusi EA
FAU - Paull, Jeremy R A
AU  - Paull JR
FAU - Price, Clare F
AU  - Price CF
FAU - Shiboski, Stephen
AU  - Shiboski S
LA  - eng
SI  - ClinicalTrials.gov/NCT00331032
GR  - HHSN266200400074C/AI/NIAID NIH HHS/United States
GR  - UL1 RR024131/RR/NCRR NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20110120
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Dendrimers)
RN  - 0 (Gels)
RN  - 25104-18-1 (Polylysine)
RN  - F8H3J9KSY9 (astodrimer)
SB  - IM
MH  - Administration, Intravaginal
MH  - Adolescent
MH  - Adult
MH  - Anti-Infective Agents/administration & dosage/*adverse effects
MH  - Colposcopy
MH  - Dendrimers
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Erythema/chemically induced
MH  - Female
MH  - Female Urogenital Diseases/chemically induced/prevention & control
MH  - Gels/therapeutic use
MH  - Humans
MH  - Kenya
MH  - Lactobacillus/isolation & purification
MH  - Polylysine/administration & dosage/*adverse effects
MH  - Sexual Abstinence
MH  - United States
MH  - Young Adult
PMC - PMC3024437
COIS- Competing Interests: Both Jeremy Paull and Clare Price are employees of 
      StarPharma Ltd, the company developing VivaGel. Jeremy Paull and Clare Price 
      served on the protocol team and supported implementation of the trial. In regards 
      to the manuscript, they made suggested changes to the Introduction, Methods and 
      Results, but not to the interpretation of the results due to potential conflict 
      of interest. This does not alter the authors' adherence to all the PLoS ONE 
      policies on sharing data and materials.
EDAT- 2011/02/12 06:00
MHDA- 2011/08/04 06:00
PMCR- 2011/01/20
CRDT- 2011/02/12 06:00
PHST- 2010/08/18 00:00 [received]
PHST- 2010/12/20 00:00 [accepted]
PHST- 2011/02/12 06:00 [entrez]
PHST- 2011/02/12 06:00 [pubmed]
PHST- 2011/08/04 06:00 [medline]
PHST- 2011/01/20 00:00 [pmc-release]
AID - PONE-D-10-01362 [pii]
AID - 10.1371/journal.pone.0016258 [doi]
PST - epublish
SO  - PLoS One. 2011 Jan 20;6(1):e16258. doi: 10.1371/journal.pone.0016258.