Back to Search
Start Over
Safety evaluation of 1% tenofovir gel in healthy men.
- Source :
-
International journal of STD & AIDS [Int J STD AIDS] 2009 Jun; Vol. 20 (6), pp. 384-6. - Publication Year :
- 2009
-
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 2:1 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.
- Subjects :
- Adenine administration & dosage
Adenine adverse effects
Adolescent
Adult
Aged
Anti-HIV Agents administration & dosage
Cellulose administration & dosage
Cellulose adverse effects
Cellulose analogs & derivatives
Circumcision, Male
Gels administration & dosage
Glycerol administration & dosage
Glycerol adverse effects
HIV Infections prevention & control
Humans
Male
Middle Aged
Organophosphonates administration & dosage
Phosphates administration & dosage
Phosphates adverse effects
Propylene Glycols administration & dosage
Propylene Glycols adverse effects
Reverse Transcriptase Inhibitors administration & dosage
Single-Blind Method
Tenofovir
Treatment Outcome
Young Adult
Adenine analogs & derivatives
Anti-HIV Agents adverse effects
Gels adverse effects
Organophosphonates adverse effects
Penis drug effects
Reverse Transcriptase Inhibitors adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 0956-4624
- Volume :
- 20
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- International journal of STD & AIDS
- Publication Type :
- Academic Journal
- Accession number :
- 19451321
- Full Text :
- https://doi.org/10.1258/ijsa.2008.008309