PMID- 12869836
OWN - NLM
STAT- MEDLINE
DCOM- 20040824
LR  - 20200930
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 33
IP  - 4
DP  - 2003 Aug 1
TI  - Safety and acceptability of penile application of 2 candidate topical 
      microbicides: BufferGel and PRO 2000 Gel: 3 randomized trials in healthy low-risk 
      men and HIV-positive men.
PG  - 476-83
AB  - OBJECTIVES: To assess safety and acceptability of penile application of BufferGel 
      (ReProtect, Baltimore, MD) and PRO 2000 Gel (Indevus Pharmaceuticals, Lexington, 
      MA)compared with placebo among low-risk sexually abstinent men and HIV-positive 
      sexually abstinent men. DESIGN: Seventy-two healthy low-risk men (36 
      uncircumcised) and 25 HIV-positive men (12 uncircumcised) were enrolled in 3 
      double-blind, single-center studies as follows: 36 low-risk men in a study of 
      BufferGel and K-Y Jelly (McNeil-PPC, Skillman, NJ) placebo; 36 low-risk men in a 
      study of PRO 2000 Gel and vehicle placebo; and 25 HIV-positive men in a crossover 
      study of BufferGel, PRO 2000 Gel, and K-Y Jelly placebo. METHODS: Participants 
      applied product to the penis on 7 consecutive nights, kept study diaries, and 
      were then interviewed and examined. Urine was tested for inflammation by 
      leukocyte esterase. RESULTS: No serious adverse events (AEs) or urethral 
      inflammation was detected. During use of BufferGel, 3 low-risk men (13%) reported 
      6 AEs and 2 HIV-positive men (8%) reported 3 AEs. During use of PRO 2000 Gel, 4 
      low-risk men (17%) reported 6 AEs and 1 HIV-positive participant (4%) had 1 AE. 
      AE rates during use of BufferGel and PRO 2000 Gel use were not significantly 
      different from rates observed during placebo. One low-risk man (4%) would object 
      to his partners using BufferGel and 3 (13%) to PRO 2000 Gel. Two HIV-positive men 
      (8%) reported they would object to partners using either BufferGel or PRO 2000 
      Gel. CONCLUSIONS: Daily application of BufferGel and PRO 2000 Gel directly to the 
      penis consecutively for 7 days was generally safe and well tolerated among 
      healthy low-risk men and HIV-positive men. These microbicides have acceptable 
      safety profiles to proceed with planned phase 3 vaginal microbicide trials.
FAU - Tabet, Stephen R
AU  - Tabet SR
AD  - Department of Medicine, University of Washington, Seattle, WA 98104, USA. 
      stabet@u.washington.edu
FAU - Callahan, Marianne M
AU  - Callahan MM
FAU - Mauck, Christine K
AU  - Mauck CK
FAU - Gai, Fang
AU  - Gai F
FAU - Coletti, Anne S
AU  - Coletti AS
FAU - Profy, Albert T
AU  - Profy AT
FAU - Moench, Thomas R
AU  - Moench TR
FAU - Soto-Torres, Lydia E
AU  - Soto-Torres LE
FAU - Poindexter III, Alfred N
AU  - Poindexter III AN
FAU - Frezieres, Ron G
AU  - Frezieres RG
FAU - Walsh, Terri L
AU  - Walsh TL
FAU - Kelly, Clifton W
AU  - Kelly CW
FAU - Richardson, Barbra A
AU  - Richardson BA
FAU - Van Damme, Lut
AU  - Van Damme L
FAU - Celum, Constance L
AU  - Celum CL
LA  - eng
GR  - U01-AI-46749/AI/NIAID NIH HHS/United States
GR  - U01-AI-47981/AI/NIAID NIH HHS/United States
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
RN  - 0 (Acrylic Resins)
RN  - 0 (BufferGel)
RN  - 0 (Naphthalenesulfonates)
RN  - 0 (PRO 2000)
RN  - 0 (Polymers)
RN  - 0 (Spermatocidal Agents)
SB  - IM
EIN - J Acquir Immune Defic Syndr. 2003 Sep 1;34(1):118
MH  - Acrylic Resins
MH  - Administration, Topical
MH  - Adult
MH  - Aged
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - HIV Infections/*prevention & control
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Naphthalenesulfonates/*administration & dosage/adverse effects
MH  - Polymers/*administration & dosage/adverse effects
MH  - Spermatocidal Agents/*administration & dosage/adverse effects
EDAT- 2003/07/19 05:00
MHDA- 2004/08/25 05:00
CRDT- 2003/07/19 05:00
PHST- 2003/07/19 05:00 [pubmed]
PHST- 2004/08/25 05:00 [medline]
PHST- 2003/07/19 05:00 [entrez]
AID - 10.1097/00126334-200308010-00008 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2003 Aug 1;33(4):476-83. doi: 
      10.1097/00126334-200308010-00008.