Safety evaluation of 1% tenofovir gel in healthy men.
Int J STD AIDS
; 20(6): 384-6, 2009 Jun.
Article
en En
| MEDLINE
| ID: mdl-19451321
ABSTRACT
This study was conducted to determine the safety of tenofovir (TFV) gel, a potential microbicide, following seven consecutive daily penile applications. Eighteen circumcised and 18 uncircumcised healthy men were randomly assigned to TFV gel versus K-Y Jelly in a 21 ratio within circumcision group. TFV gel or K-Y Jelly was applied onto the penis at bedtime and washed off 6-10 hours later. Safety was assessed by reported symptoms, findings and laboratory tests. Three of 24 (13%) men in the TFV group reported mild genital symptoms compared with two of 11 (18%) men in the K-Y group. Few mild genital findings were observed and no significant systemic toxicities were reported or observed. TFV gel applied to the penis for seven days was well tolerated locally and systemically and it is unlikely that male partners exposed to small amounts of TFV gel will experience significant genital or systemic toxicity.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Pene
/
Adenina
/
Inhibidores de la Transcriptasa Inversa
/
Fármacos Anti-VIH
/
Organofosfonatos
/
Geles
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
/
Adult
/
Aged
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Int J STD AIDS
Asunto de la revista:
SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS)
Año:
2009
Tipo del documento:
Article
País de afiliación:
Estados Unidos