A 48 Week, Phase II, Open-Label, Multi-Cohort, Multicenter Study to Evaluate the Safety , Tolerability, Pharmacokinetics, and Antiviral Activity of GW433908/Ritonavir QD when Administered to HIV-1 Infected, Antiretrovitral Naive and Experienced, Pediatric07/01/2002 - 06/30/2006 (PI)
GlaxoSmithKline, Inc.
Open-Label Multicenter Multiple Dose Phase III Study of the Population Pharmacokinetics of IV Synecid 7.5 mg/kg q8h in &5 Pediatric Patients11/01/2001 - 10/31/2003 (PI)
Aventis Pharmaceuticals Inc
Investigation of CD11b Expression in Neonates Using New Laser Scanning Cytometer Technology10/19/1999 - 09/30/2000 (PI)
CompuCyte Corporation
IMPAACT 2023: A Phase I Study of the Safety and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-107/01/2022 - 06/30/2025 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University ViiV Healthcare
IMPAACT Leadership Group - 2032 Protocol Chair (remdescivir)07/01/2023 - 11/30/2024 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University NIH NIAID
LDR 01: LOC-IMPAACT Leadership Group: Mirochnick01/01/2014 - 11/30/2024 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University NIH NIAID5UM1AI068632-18
IMPAACT 2032: Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States12/01/2021 - 06/30/2023 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University Gilead Sciences
?P1026S - IMPAACT 1026S Pharmacokinetic Properties of ARVs during Pregnancy and Postpartum07/01/2021 - 12/31/2022 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University NIH NIAID5UM1AI068632-17
Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the US
06/01/2020 - 11/30/2022 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University NIH NIAID3UM1AI068632-14S2
Enhanced maternal and fetal PBPK models to predict drug exposures of novel oral and long-acting antivirals during pregnancy
08/09/2020 - 07/31/2022 (Subcontract PI)
PI:
Mark H. Mirochnick, MDThe Regents of the University of Calif., U.C. San Diego NIH NICHD5R21HD102856-02
LDR09 - P1026s: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy...07/01/2019 - 06/30/2021 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University Gilead Sciences
IMPAACT 2007 - Phase I Safety and Pharmacokeneticks of Marviorc in HIV 1 Exposed Infants at Risk …07/01/2016 - 12/31/2020 (Subcontract PI)
PI:
Mark H. Mirochnick, MDJohns Hopkins University PHIVCO UK II Ltd
Plugging Hair ARV Levels as Adherence Biomarkers into HIV Prevention Trials12/01/2012 - 11/30/2016 (PI)
Univ of California, San Francisco NIH-NIAID
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IMPAACT: HIV Treatment SC VC06/01/2012 - 12/31/2014 (PI)
Johns Hopkins University NIH-NIAID
IMPAACT: Network Executive Committee (NEC)06/01/2012 - 12/31/2013 (PI)
Johns Hopkins University NIH-NIAID
IMPAACT Group Leadership07/01/2006 - 06/30/2013 (PI)
Social & Scientific Systems Inc. NIH-NIAID
Pharmacokinetic Study of Praziquantel During Pregnancy04/01/2009 - 03/31/2013 (PI)
Rhode Island Hospital NIH-NIAID
IMPAACT Leadership: International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT)06/01/2011 - 05/31/2012 (PI)
Social & Scientific Systems Inc. NIH-NIAID
Congenital Transmission of Lineages I and II of Trypanasoma Cruzi09/08/2011 - 02/29/2012 (PI)
Tulane Univ Health Sciences Center NIH-NIA
Phase III Randomized Trial of the Safety and Efficency11/01/2003 - 11/30/2010 (PI)
WESTAT NIH-NICHD
Safety Pharmacokinetics & Efficacy of Artemether & Lumefantrine in Pregnant Women07/01/2008 - 06/30/2009 (PI)
NIH-NIAID1R34AI076610-01
Antiretroviral Pharmacology/Lactating Mother/Infants07/01/2005 - 06/30/2009 (PI)
NIH-NICHD1 R21 HD051470-02
A Phase I Open Label Trial of the Safety and Pharmcokinetics07/01/2004 - 06/30/2006 (PI)
Family Health International NIH-NIAIDU01 AI46749-757-1
Phase III Randomized Trial Of11/01/2001 - 10/31/2003 (PI)
WESTAT NIH