Publications by authors named "Jarret C Engstrom"
Article Synopsis
- The CHARM-03 study tested the safety and pharmacokinetics of oral maraviroc (MVC) and MVC 1% gel in healthy HIV-uninfected men and women through various dosing methods (oral, rectal, vaginal).
- Out of 20 enrolled participants, 25 adverse events were reported, mostly mild, and participants found all products acceptable with no local inflammation experienced.
- Although drug concentrations were measurable after administration, efficacy in protecting against HIV was limited, possibly due to rapid drug disassociation from tissue.
Objectives: The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection.
Methods: MSM and TGW aged 18-30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW.
Objectives: The CHARM-01 study characterized the safety, acceptability, pharmacokinetics (PK), and pharmacodynamics (PD) of three tenofovir (TFV) gels for rectal application. The vaginal formulation (VF) gel was previously used in the CAPRISA 004 and VOICE vaginal microbicide Phase 2B trials and the RMP-02/MTN-006 Phase 1 rectal safety study. The reduced glycerin VF (RGVF) gel was used in the MTN-007 Phase 1 rectal microbicide trial and is currently being evaluated in the MTN-017 Phase 2 rectal microbicide trial.
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