PMID- 24070431
OWN - NLM
STAT- MEDLINE
DCOM- 20140917
LR  - 20211021
IS  - 1931-8405 (Electronic)
IS  - 0889-2229 (Print)
IS  - 0889-2229 (Linking)
VI  - 30
IP  - 2
DP  - 2014 Feb
TI  - A randomized male tolerance study of dapivirine gel following multiple topical 
      penile exposures (MTN 012/IPM 010).
PG  - 184-9
LID - 10.1089/AID.2013.0170 [doi]
AB  - Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor with a 
      favorable safety profile following vaginal application. A penile tolerance study 
      was conducted prior to further development of DPV as a candidate vaginal 
      microbicide. Twenty-four circumcised and 24 uncircumcised (N=48) healthy 
      HIV-negative male participants aged 18 years or older were randomized 2:1:1 to 
      apply DPV 0.05% gel, matched placebo gel, or universal placebo gel, respectively, 
      to their penis once daily for 7 sequential days. The safety, acceptability, and 
      pharmacokinetic profile of DPV 0.05% gel were assessed by the presence of Grade 2 
      or higher genitourinary adverse events (AEs) and systemic AEs, a behavioral 
      questionnaire, and pharmacokinetic plasma blood draw, respectively, at the final 
      clinic visit (FCV). There were no Grade 2 genitourinary AEs in 47 participants 
      completing the FCV. One participant in the DPV arm failed to attend the FCV. 
      There were 13 AEs reported; all were Grade 1 except one Grade 2 corneal 
      laceration unrelated to study product. Participants liked the gel to a moderate 
      extent, yet 72% reported they would be "very likely" to use a gel like the one 
      they used in the study every time they have intercourse. DPV was detectable in 
      plasma in all 23 DPV arm study participants at the FCV. On average, the 
      circumcised participants' DPV concentrations were 54% of those in uncircumcised 
      participants (p=0.07). Topical seven-day penile application of DPV 0.05% gel was 
      locally and systemically safe, was acceptable to male participants, and resulted 
      in systemic exposure to the drug.
FAU - Cranston, Ross D
AU  - Cranston RD
AD  - 1 University of Pittsburgh School of Medicine , Pittsburgh, Pennsylvania.
FAU - Hoesley, Craig
AU  - Hoesley C
FAU - Carballo-Dieguez, Alex
AU  - Carballo-Dieguez A
FAU - Hendrix, Craig W
AU  - Hendrix CW
FAU - Husnik, Marla
AU  - Husnik M
FAU - Levy, Lisa
AU  - Levy L
FAU - Hall, Wayne
AU  - Hall W
FAU - Soto-Torres, Lydia
AU  - Soto-Torres L
FAU - Nel, Annalene M
AU  - Nel AM
LA  - eng
GR  - UM1 AI069494/AI/NIAID NIH HHS/United States
GR  - UM1 AI068615/AI/NIAID NIH HHS/United States
GR  - P30 MH043520/MH/NIMH NIH HHS/United States
GR  - UM1 AI106707/AI/NIAID NIH HHS/United States
GR  - UL1 TR000005/TR/NCATS NIH HHS/United States
GR  - UM1AI068615/AI/NIAID NIH HHS/United States
GR  - UM1 AI068633/AI/NIAID NIH HHS/United States
GR  - 5U01AI068633/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
DEP - 20131026
PL  - United States
TA  - AIDS Res Hum Retroviruses
JT  - AIDS research and human retroviruses
JID - 8709376
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Gels)
RN  - 0 (Placebos)
RN  - 0 (Pyrimidines)
RN  - TCN4MG2VXS (Dapivirine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-HIV Agents/*administration & dosage/*adverse effects/pharmacokinetics
MH  - Chemoprevention/*adverse effects/*methods
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Gels/administration & dosage/adverse effects/pharmacokinetics
MH  - Humans
MH  - Male
MH  - *Patient Acceptance of Health Care
MH  - Placebos/administration & dosage
MH  - Plasma/chemistry
MH  - Pyrimidines/*administration & dosage/*adverse effects/pharmacokinetics
MH  - Surveys and Questionnaires
MH  - Young Adult
PMC - PMC3910451
EDAT- 2013/09/28 06:00
MHDA- 2014/09/18 06:00
PMCR- 2015/02/01
CRDT- 2013/09/28 06:00
PHST- 2013/09/28 06:00 [entrez]
PHST- 2013/09/28 06:00 [pubmed]
PHST- 2014/09/18 06:00 [medline]
PHST- 2015/02/01 00:00 [pmc-release]
AID - 10.1089/aid.2013.0170 [pii]
AID - 10.1089/AID.2013.0170 [doi]
PST - ppublish
SO  - AIDS Res Hum Retroviruses. 2014 Feb;30(2):184-9. doi: 10.1089/AID.2013.0170. Epub 
      2013 Oct 26.