Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet (RMP02-MTN006)
This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Microbicide Trials Network
Information provided by:
First received: September 24, 2009
Last updated: August 27, 2015
Last verified: August 2015
No Study Results Posted on ClinicalTrials.gov for this Study
|Study Status:||This study has been completed.|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Richardson-Harman N, Hendrix CW, Bumpus NN, Mauck C, Cranston RD, Yang K, Elliott J, Tanner K, McGowan I, Kashuba A, Anton PA. Correlation between compartmental tenofovir concentrations and an ex vivo rectal biopsy model of tissue infectibility in the RMP-02/MTN-006 phase 1 study. PLoS One. 2014 Oct 28;9(10):e111507. doi: 10.1371/journal.pone.0111507.
Yang KH, Hendrix C, Bumpus N, Elliott J, Tanner K, Mauck C, Cranston R, McGowan I, Richardson-Harman N, Anton PA, Kashuba AD. A multi-compartment single and multiple dose pharmacokinetic comparison of rectally applied tenofovir 1% gel and oral tenofovir disoproxil fumarate. PLoS One. 2014 Oct 28;9(10):e106196. doi: 10.1371/journal.pone.0106196.
Anton PA, Cranston RD, Kashuba A, Hendrix CW, Bumpus NN, Richardson-Harman N, Elliott J, Janocko L, Khanukhova E, Dennis R, Cumberland WG, Ju C, Carballo-Diéguez A, Mauck C, McGowan I. RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate. AIDS Res Hum Retroviruses. 2012 Nov;28(11):1412-21. doi: 10.1089/AID.2012.0262.