Metabolomics,Unknown,Transcriptomics,Genomics,Proteomics

Dataset Information

Systems Biology Analysis of Tenofovir 1% Gel in a Phase I Rectal Microbicide Trial

ABSTRACT: In MTN-007, a phase 1, randomized, double-blinded rectal microbicide trial, we used systems genomics/proteomics to determine the effect of tenofovir 1% gel, nonoxynol-9 2% gel, placebo gel or no treatment on rectal biopsies taken at baseline, after one application or after seven daily applications (15 subjects/arm). Experiments were repeated using primary vaginal epithelial cells from four healthy women. 192 Arrays (8 donors per treatment group, 2 biopsy sites per donor (9cm and 15 cm), biopsies taken at baseline, after a single application, and after 7 daily applications)

ORGANISM(S): Homo sapiens

SUBMITTER: Lamar Fleming

PROVIDER: E-GEOD-57025 | biostudies-arrayexpress |

REPOSITORIES: biostudies-arrayexpress

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Publications

Mucosal effects of tenofovir 1% gel.

Hladik Florian F Burgener Adam A Ballweber Lamar L Gottardo Raphael R Vojtech Lucia L Fourati Slim S Dai James Y JY Cameron Mark J MJ Strobl Johanna J Hughes Sean M SM Hoesley Craig C Andrew Philip P Johnson Sherri S Piper Jeanna J Friend David R DR Ball T Blake TB Cranston Ross D RD Mayer Kenneth H KH McElrath M Juliana MJ McGowan Ian I

eLife 20150203

Tenofovir gel is being evaluated for vaginal and rectal pre-exposure prophylaxis against HIV transmission. Because this is a new prevention strategy, we broadly assessed its effects on the mucosa. In MTN-007, a phase-1, randomized, double-blinded rectal microbicide trial, we used systems genomics/proteomics to determine the effect of tenofovir 1% gel, nonoxynol-9 2% gel, placebo gel or no treatment on rectal biopsies (15 subjects/arm). We also treated primary vaginal epithelial cells from four h ...[more]

PMID: 25647729

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Project description:Interventions: Advanced endoscopic resection techniques such as Endoscopic Mucosal Resection (EMR) have provided a minimally invasive alternative to surgery for curative management of advanced mucosal neoplasia. The safety profile and outcomes of EMR techniques are significantly better than surgical resection however significant post resection bleeding remains an ongoing challenge. There is currently no consistently recommended strategy to reduce the risk of post-EMR bleeding that has been adopted as standard of care. In particular, patients on antithrombotic therapy are at high risk of post procedure bleeding and strategies to mitigate this are required. A recently introduced haemostatic gel (Purastat, 3D-Matrix) that acts as a self assembling nanoparticle matrix has demonstrated efficacy as a topical haemostat in controlling oozing bleeding in a number of anatomical locations including applications in ENT, Gynaecology, and endoscopy. The haemostatic gel will be applied to the post EMR mucosal defect to consecutive eligible, consenting patients undergoing endoscopic mucosal resection who are on anti-thrombotic therapy (excluding single agent aspirin) or multiple agents. We will be applying aliquots of 1-5mLs of the gel matrix; the exact amount will be determined by the size of the defect remaining post excision of the target lesion. Gel will be applied endoscopically at the time of the procedure via the proceduralist until the entire defect has been covered - this is considered the one and only time the gel will be delivered. Primary outcome(s): Rate of clinically significant post-procedural bleeding requiring further intervention (such as blood transfusion, admission to hospital, or other blood products (such as platelets, fresh frozen plasma, prothrombinex) This will be assessed clinically by the presence of gastrointestinal bleeding (such as per-rectal bleeding) where patients were given blood products as documented in the medical record.[30 days post endoscopic procedure] Study Design: Purpose: Prevention; Allocation: Non-randomised trial

Dataset Information

Systems Biology Analysis of Tenofovir 1% Gel in a Phase I Rectal Microbicide Trial

Publications

Mucosal effects of tenofovir 1% gel.

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