DESCRIPTIONPERSONNELSERVICESPUBLICATIONSTRAINING

Mission

The overarching goal of the Clinical Pharmacology and Analytical Chemistry (CPAC) Core is to facilitate the development of safe, effective strategies for HIV prevention, treatment, and cure. To achieve this goal, the CPAC Core provides expertise in small molecule drug development to assist investigators in nearly all aspects of HIV pharmacology research. This full-spectrum support, unique to our Core facility, helps advance preclinical and clinical HIV research towards ending the HIV epidemic.

Strategy

Members of the CPAC Core work with investigators to identify and deliver services that best meet their research needs. Through highly interactive collaboration, the Core helps progress activities at each stage of HIV research, from study design and grant writing, to bioanalysis and mass spectrometry imaging, to data modeling and simulation, to publication and future work. The Core’s activities are augmented by institutional support from the UNC Eshelman School of Pharmacy, which links the Core with faculty renowned for their expertise in specialized fields of pharmacology.

The CPAC Core supports the global community of HIV researchers through fundamental services in drug quantification. These services are performed within a CAP/CLIA-accredited environment using six redundant AB Sciex instruments for LC-MS/MS analysis and two IR-MALDESI systems for small-molecule imaging. Redundancy allows for rapid resulting for studies with large sample numbers, as well as simultaneous assay development and sample analysis activities performed on consistent platforms. The Core’s bioanalytical capacity helps sustain collaborations within every inhabited continent.

Global CPAC Core Collaborations

ACKNOWLEDGING THE CPAC CORE

All work provided by the UNC CFAR Clinical Pharmacology and Analytical Chemistry (CPAC) Core that results in a publication should acknowledge the Core’s contributions. Proper acknowledgment helps demonstrate the Core’s impact on the HIV research community and ultimately helps ensure the Core’s sustainability as a resource in HIV pharmacology. When possible, please send a copy of the accepted manuscript or published paper resulting from Core support to Lauren Tompkins or Mackenzie Cottrell. Similarly, please send the title of any grant proposal that the CPAC Core helps develop.

News & Engagement

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Faculty

Angela DM Kashuba, B.Sc.Phm., Pharm.D., DABCP, FCP

Core Director

After obtaining her Bachelor of Science in pharmacy at the University of Toronto, Angela Kashuba, Pharm.D., completed a general practice residency at Women’s College Hospital and practiced as a critical care pharmacist at Mount Sinai Hospital in Toronto, Ontario. Kashuba received her Pharm.D. from the State University of New York at Buffalo and completed postdoctoral pharmacology training at the Clinical Pharmacology Research Center at Bassett Healthcare in Cooperstown, New York. Kashuba joined the UNC-Chapel Hill faculty in 1997.

She was named the John and Deborah McNeill, Jr. Distinguished Professor in 2013 and appointed chair of the Division of Pharmacotherapy and Experimental Therapeutics in 2015. She serves as director of the UNC CFAR Clinical Pharmacology and Analytical Chemistry (CPAC) Core, director of the Analytical Chemistry Laboratory for the Verne S. Caviness General Clinical Research Center, and Dean of the UNC Eshelman School of Pharmacy. She is active in the clinical community as a diplomat of the American Board of Clinical Pharmacology and as a member of the PHASES Working Group.

Kashuba’s research interests surround the clinical pharmacology of antiretroviral agents used in the treatment and prevention of HIV infection. Current projects focus on characterizing mechanisms of antiretroviral distribution in tissue reservoirs of HIV, developing mass spectrometry imaging methods for quantifying adherence, and advancing interventions for real-time adherence monitoring (ENLIGHTEN clinical study).

100C Beard Hall
CB# 7355
Chapel Hill, NC
akashuba@unc.edu
Fax: 919-962-0644
Office Phone: 919-966-1122

Mackenzie Cottrell, Pharm.D., MS, BCPS, AAHIVP

Core Co-Director

Mackenzie Cottrell is an Assistant Professor in the Division of Pharmacotherapy and Experimental Therapeutics at the UNC Eshelman School of Pharmacy. She completed an American Board of Clinical Pharmacology-accredited T32 clinical pharmacology fellowship and an American College of Clinical Pharmacy-accredited HIV pharmacology fellowship within the Kashuba Laboratory. Cottrell joined the UNC CFAR in 2015 as the Assistant Director of the CPAC Core and transitioned to Co-Director in 2019. Her research focuses on the pharmacology of antiretrovirals used for HIV prevention in mucosal tissues, on the discovery of new latency-reversing agents for HIV cure, and on developing long-acting formulations of antiretrovirals.

mlcottre@email.unc.edu
Office Phone: 919-843-0321

Elias Rosen, Ph.D.

Director of Mass Spectrometry Imaging

rosen

Elias Rosen is an Associate Professor in the Division of Pharmacotherapy and Experimental Therapeutics at the UNC Eshelman School of Pharmacy. He joined the UNC CFAR in 2014 to lead the CPAC Core’s research program designed to translate the fundamental performance of a novel mass spectrometry imaging platform, IR-MALDESI, for clinical applications. His research focuses on the development of methods to measure the intracellular distribution of therapeutics and their metabolites in a variety of biological matrices using IR-MALDESI. He is currently quantifying the penetration of drugs relevant to HIV treatment and eradication into putative viral reservoirs and combining this approach with traditional imaging modalities to evaluate efficacy of experimental treatment regimens.

eli@unc.edu
Office Phone: (919) 843-7806

Staff

Hannah Bryan, BS

QA Manager and Lab Safety Supervisor

Hannah Bryan joined the UNC CFAR in 2017 to lead the CPAC Core’s Quality Assurance/Control (QA/QC) program. She holds a BS in Animal Science from NC State University and, prior to joining the Core, spent six years conducting both discovery and regulated research for a clinical research organization in Research Triangle Park. Hannah currently oversees all quality control and quality assurance aspects of the analytical study data that is generated in the lab, maintains CLIA and CAP certification and standard operating procedures, submits validation reports to the DAIDS-sponsored CPQA program, oversees external proficiency testing, and ensures laboratory safety through training and procedural compliance.

hebryan1@email.unc.edu
Office Phone: 919-843-2791

Lauren Tompkins, MS, BA

Core Manager

LT Headshot

Lauren Tompkins joined the UNC CFAR in 2020 to ensure the scientific agenda of the CPAC Core is executed efficiently and effectively. She brings over 12 years of experience in scientific and medical writing and over 8 years in virology research (with 4 years specifically in HIV) to her role in program management and communications. She liaises with Core users to expedite the planning and execution of their clinical pharmacology needs, coordinates and participates in strategic planning activities and progress reporting, and supports activities in scientific communication, engagement, and outreach.

ltompkins@unc.edu
Office Phone: (919) 843-7806

JUSTIN JONES, BS

Research Assistant

JJ Headshot

Justin Jones received a BS in biology with a concentration in Health Sciences from High Point University in North Carolina. Prior to joining the CPAC Core in 2019, he worked as a Medical Scribe in an underserved parish of Louisiana. Justin currently oversees procurement and inventory activities, maintains sample chain of custody, and coordinates with investigators for sample shipment and receipt.

jecjones@email.unc.edu
Office Phone: (919) 843-7806

AMANDA POLISENO, BS

CLINICAL RESEARCH COORDINATOR

AP Headshot

Amanda Poliseno graduated from the University of South Florida in 2015 with a BS in public health. She joined the CPAC Core in 2017 as a Clinical Research Assistant and became the Core’s Clinical Research Coordinator in 2020. Amanda brings her previous training as an EMT to support her role overseeing the conduct of clinical pharmacology studies. Additionally, she collaborates with the Clinical Core to source incurred biological specimens for bioanalytical method development.

amanda_poliseno@unc.edu
Office Phone: (919) 962-5344

Craig Sykes, MS

Bioanalytical Method Development Scientist

Craig Sykes

Craig Sykes joined the UNC CFAR in 2011 to lead LC-MS/MS assay development for the CPAC Core. He holds a BS in chemistry from UNC-Wilmington and an MS in analytical chemistry from UNC-Chapel Hill, and he has >20 years of experience developing methods in complex matrices in a GLP environment. Craig oversees a team of 3 bioanalytical research scientists as they develop and perform customized LC-MS/MS assays to respond to specific research needs. His research focuses on developing LC-MS/MS methods for uncommon biological matrices such as hair, tissue, and dried blood spots (DBS).

craig_sykes@unc.edu
Office Phone: 919-843-2791

Nicole White, BS

Bioanalytical Research Specialist

Nicole White has been an outstanding analytical chemist at UNC since 1994, and she has received awards in recognition of her exceptional service. Nicole joined the UNC CFAR in 2004 and has been heavily involved in the CPAC Core’s bioanalytical functions ever since. In addition to supporting LC-MS/MS activities, she now performs routine sample analysis by IR-MALDESI and is helping to expand applications of the IR-MALDESI platform. She has an extensive record of accomplishments, having contributed to recent publications in mass spectrometry imaging of hair and tissue, and in the characterization of antiretrovirals in HIV tissue reservoirs, including the brain, by LC-MS/MS.

nicole_white@med.unc.edu
Office Phone: (919) 843-2791

Amanda Schauer, BA

Senior Research Scientist

Amanda Schauer joined the CPAC Core in 2015 to support bioanalytical activities. She holds a BA in chemistry from NC State University and has experience working for a clinical research organization performing sample analysis and quality control activities in a GLP-regulated environment. Amanda supports all bioanalytical activities, including LC-MS/MS method development, validation, and application. She pioneered the Core’s development of a method for adherence monitoring using dried blood spots.
aps5@email.unc.edu
Office Phone: (919) 843-2791

Brian van Horne, BS

Bioanalytical Research Specialist

Brian Van Horne received a BS in chemistry from the State University of New York at Oswego. Before joining the Kashuba lab in 2017, he worked as a Lab Technician in toxicology at Syracuse. Brian joined the CPAC Core in 2018 to support bioanalytical activities. His research focuses on LC-MS/MS method development, validation, and application.

bvanhorn@email.unc.edu
Office Phone: (518) 926-8062

 

Clinical Pharmacology Services

Expertise in clinical pharmacology is the bedrock of the CPAC Core and the central mechanism by which the Core executes its Mission. This guiding principle drives the Core’s research agenda, strategic plan, and service framework in effort to advance NIH HIV research priorities spanning prevention, treatment, and cure. Services in clinical pharmacology are available at nearly every stage of preclinical and clinical HIV research, making the CPAC Core a unique resource outside the industry setting.

Available Services
Planning & Study Design: The CPAC Core has over 20 years of experience in pharmacology to facilitate the development of preclinical and clinical research approaches through collaborative study design. Services include assistance with hypothesis framing, experimental factor identification, bioanalytical method comparison, and strategy justification, as well as pharmacokinetic/pharmacodynamic (PK/PD) study design, planning, and optimization.

Grantsmanship: In the most recent CFAR funding cycle, the CPAC Core helped develop and submit >71 grant applications to the NIH, non-profit organizations such as the Bill and Melinda Gates Foundation, and investigator-sponsored research programs. Grantsmanship services include multi-year budget planning, writing of major sections, collaborative editing, constructive critique of existing proposals, and resubmission strategizing. Letters of support, biosketches, and other support pages are also available upon request.

Coordination & Project Management: To support investigators throughout the trajectory of long-term and/or large-scale pharmacology studies, the CPAC Core offers consultative services in protocol implementation, operation, and adherence monitoring, in addition to guidance for timeline logistics, coordination, and communication.

Abstract & Manuscript Preparation: The CPAC Core strives to maximize scientific impact and promote research fellowship through communicating advancements in HIV pharmacology research. Core personnel routinely assist with abstract and manuscript composition, drafting figures and tables, selecting appropriate conferences/journals for submission, and responding to reviewer comments.

PK/PD Computation & Pharmacometrics: The CPAC Core offers PK/PD data analysis, interpretation, and modeling, as well as services in Monte-Carlo simulations, optimal study design calculations, and clinical trial simulation. To expand provision of computational services, the CPAC Core recently partnered with Dr. Julie Dumond and the UNC Pharmacometrics Core Facility.

Therapeutic Drug Monitoring: The CPAC Core offers therapeutic drug monitoring (TDM) with interpretive reports for nearly all FDA-approved antiretrovirals in a CAP/CLIA-accredited environment. Please contact Lauren Tompkins or Mackenzie Cottrell with TDM inquiries.

Training & Mentoring: Fostering the next generation of scientific leadership is critical for encouraging progress towards ending the HIV epidemic. The Core offers consultative services such as teaching or clarification of essential concepts in pharmacology, training in theory and use of bioanalytical techniques for drug detection, and software tutorials (SigmaPlot, WinNonlin, Agilent ChemStation). To support early-stage investigators and investigators new to HIV, Core personnel serve as mentors for CFAR Developmental Awardees and NIH Career Development (K) awardees. Core personnel also provide mentoring for graduate students working on CFAR projects and offer internships for undergraduates to enhance awareness of clinical pharmacology and analytical chemistry career pathways.

Bioanalytical Services

The CPAC laboratory provides state-of-the-art, customizable services in bioanalytical chemistry to support the HIV research community. A large portfolio of LC-MS/MS methods are available for quantifying drugs, drug metabolites, and other small molecules in plasma and in a variety of uncommon/complex biological matrices such as tissue, dried blood spots (DBS), and hair. Preclinical and clinical samples analyzed with these methods can be divided into 3 categories (or “Tiers”) based on research needs and bioanalytical criteria:

Tier 1 – Discovery (preclinical data, preliminary data, research studies)
Tier 2 – Qualified (preclinical or clinical research purposes suitable for publication, method qualified by 1 day of Precision and Accuracy)
Tier 3 – Validated (clinical studies for FDA submission, TDM, PT, method fully validated according to FDA guidelines)

The CPAC Core recovers costs through a registered recharge center. Service rates are calculated and reviewed at least every two years and are designed to cover costs without profit. Rates for sample analysis and method development are stratified by level of service. Budgets can be prepared on a per sample basis for a streamlined approach to service requests. Contact Lauren Tompkins for budgeting inquiries. All bioanalytical services require completion of a shipment manifest prior to scheduling the shipment with Justin Jones.

Bioanalytical Experience and Existing Methods

The following tables illustrate the bioanalytical experience of the CPAC laboratory. Drugs and other small molecules (“analytes”) are quantified by LC-MS/MS at each Tier level as described below. Methods developed for a higher Tier level can be used to analyze samples at a lower Tier level, and LC-MS/MS methods can be developed for virtually any compound.

Tier 1 (Discovery) Level
Tier 1 bioanalysis is highly flexible to accommodate early-stage research needs in a cost-effective manner. The CPAC laboratory has quantified the following analytes in a variety of species/matrices by LC-MS/MS at the Tier 1 (Discovery) level.
AntiretroviralsLatency-Reversing AgentsOther Compounds
3TCNVPbryostatin-1acyclovir
3TCtpRALingenol-dibenzoateampicillin
ABCRPVpanobinostatapixaban
APVRTVprostratincanrenone
ATVSQVromidepsincefazolin
BICTAFvorinostatdabigatran
CABTFVadditional proprietary compoundsdATP
CBVtpTFVdpdCTP
D4TZDVdGTP
DORdehydronifedipine
DPVetonogestrel
DRVlevonorgestrel
DTGmeropenem
EFdAmetronidazole
EFdAtpnifedipine
EFVpiperacillin
ETRprogesterone
EVGpyrazinamide
FTCpyrazinoic acid
FTCtprivaroxaban
LPVspironolactone
MK-2048tazobactam
MVC2,3,5-PTCA (melanin biomarker)
NFV7a-thiomethyl spironolactone
Tier 2 (Qualified) Level
Currently available Tier 2 (Qualified) LC-MS/MS methods developed by the CPAC laboratory are listed below. Within each row, any/all of the analytes can be quantified in a single sample of the matrix indicated. Additionally, a single sample can be analyzed with >1 method to quantify a more diverse set of analytes. All Tier 2 methods are Qualified by 1 day of Precision and Accuracy.

*Note: Lower limit of quantification varies by analyte in certain methods.
SpeciesMatrixAnalyteLower Limit of Quantification
HumanBreastmilk3TC, TFV1 ng/mL
HumanBreastmilkATV0.5 ng/mL
HumanBreastmilkD4T10 ng/mL
HumanBreastmilkETR, EVG, EFV25 ng/mL*
HumanCerebrospinal FluidAPV, ATV, DRV, EVG, LPV, RTV, TFV, 3TC, FTC, ABC, ZDV, MVC, RAL, NVP1 ng/mL*
HumanCerebrospinal Fluid and PlasmaEFV, EVG1 ng/mL
HumanCervicovaginal and Rectal FluidTFV, FTC2 ng/mL
HumanCervicovaginal FluidBIC, DOR0.25 ng/mL*
HumanCervicovaginal FluidRPV1 ng/mL
HumanCervicovaginal LavageTFV, FTC, RAL, 3TC5 ng/mL*
HumanRectal FluidBIC, DOR0.25 ng/mL*
HumanSemenTFV, FTC, RAL5 ng/mL
HumanSeminal PlasmaBIC, DOR0.25 ng/mL*
HumanSeminal PlasmaTFV, FTC10 ng/mL
HumanSerumVOR1 ng/mL
HumanTissueAPV, ATV, EVG, DRV, LPV, RTV1 ng/mL
HumanTissueBIC0.1 ng/mL
HumanTissuedATP, dCTP0.1 ng/mL
HumanTissueDTG, MVC, RPV1 ng/mL
HumanTissueEFV, RPV5 ng/mL
HumanTissueRAL1 ng/mL
HumanTissueRAL, DTG, RPV0.05 ng/mL
HumanTissueTFV, FTC, 3TC, TFVdp, FTCtp, 3TCtp0.3 ng/mL
HumanWeck CelsEFV, ATV, NVP0.2 ng/mL
HumanWhole BloodDTG, MVC3 ng/mL*
HumanWhole BloodTFVdp, FTCtp, 3TCtp300 fmol/sample
DogPlasmaEFdA0.1 ng/mL
MinipigPlasmaEFdA0.1 ng/mL
MousePlasmaDTV, MVC, RPV1 ng/mL
MousePlasmaCAB, RPV5 ng/mL*
MousePlasmaprogesterone0.5 ng/mL
MouseTissueCAB, RPV0.1 ng/mL*
MultispeciesPlasmaATV, RTV1 ng/mL
MultispeciesPlasmaEFV0.25 ng/mL
NHPPlasmaEFdA0.1 ng/mL
NHPPlasmaTFV, FTC, 3TC2 ng/mL
RabbitPlasmaEFdA0.1 ng/mL
RabbitPlasmaetonogestrel, levonorgestrel0.5 ng/mL
RabbitPlasmaTAF0.1 ng/mL
RabbitPlasmaTFV1 ng/mL
RatPlasmaEFdA0.1 ng/mL
N/ACell Lysate3TCtp300 fmol/mL
N/APBMC LysateEFdAtp0.05 ng/mL
N/APBMC LysateTFVdp0.02 ng/mL
N/APBMC LysateTFVdp, FTCtp, 3TCtp, CBVtp, EFdAtp, dATP, dCTP, dGTP0.1 ng/mL*
Tier 3 (Validated) Level
Currently available Tier 3 (Validated) LC-MS/MS methods developed by the CPAC laboratory are listed below. Within each row, any/all of the analytes can be quantified in a single sample of the human matrix indicated. Additionally, a single sample can be analyzed with >1 method to quantify a more diverse set of analytes. All Tier 3 methods are fully Validated according to FDA guidelines.
MatrixAnalyteLower Limit of Quantification
Breast Milk3TC, LPV, NFV, NVP, RTV, ZDV10 ng/mL
Cervicovaginal and Rectal FluidTAF0.2 ng/mL
Cervicovaginal FluidDTG1 ng/mL
Cervicovaginal FluidTFV, FTC2 ng/mL
Dried Blood SpotsTVFdp, FTCtp, 3TCtp100 fmol/sample
HairATV, RAL0.1 ng/mL
HairDRV0.05 ng/mL
HairDTG5 pg/mL
HairEVG0.05 ng/mL
PlasmaAPV, ATV, DRV, LPV, RTV1 ng/mL
PlasmaBIC, DOR, RAL20 ng/mL (BIC), 3 ng/mL (DOR), 10 ng/mL (RAL)
PlasmaDTG, RPV, MVC1 ng/mL
PlasmaEFV50 ng/mL
PlasmaETR, EVG25 ng/mL
PlasmaMVC, RAL, TFV, FTC5 ng/mL
PlasmaTAF0.05 ng/mL
PlasmaTFV, FTC0.25 ng/mL
PlasmaÿZDV, 3TC, ABC, TFV, FTC, NVP1 ng/mL
Rectal Fluid (Swabs)DTG1 ng/mL
Seminal PlasmaDTG1 ng/mL
Serumvorinostat1 ng/mL
TissueTAF0.02 ng/mL
TissueTFV, TFVdp0.02 ng/mL
Vaginal TissueTFV, FTC, TFVdp, FTCtp0.3 ng/mL
Vaginal, Cervical, and Rectal TissueDTG0.02 ng/mL
PBMC LysateÿTFVdp, FTCtp, dATP, dCTP0.02 ng/mL
PBMC LysateTFVdp, FTCtp0.25 pmol/mL (TFVdp), 2.5 pmol/mL (FTCtp)
Upper Layer Packed Cell LysateTFVdp, FTCtp10 pmol/mL (TFVdp), 5 pmol/mL (FTCtp)
Analytical Method Development

The UNC CFAR CPAC Core can also provide the following for investigators:

  1. Calibration or validation of routine antiretroviral methods in all biological matrices.
  2. Calibration or validation of routine intracellular antiretroviral methods.
  3. Development of new/customized analytical methodology, in particular HPLC-MS/MS methods, to meet CFAR needs.
  4. Comparison of competing methodologies (new and old) to identify optimal methods.
  5. Interpretive analyses of results.

Publications

2020

Freiberg MS, Cheng DM, Gnatienko N, Blokhina E, Coleman SM, Doyle MF, Yaroslavtseva T, Bridden C, So-Armah K, Tracy R, Bryant K, Lioznov D, Krupitsky E and Samet JH. Effect of Zinc Supplementation vs Placebo on Mortality Risk and HIV Disease Progression Among HIV-Positive Adults With Heavy Alcohol Use: A Randomized Clinical Trial. JAMA Netw Open. 3(5):e204330. 2020. PMC7210486.

Gay CL, Neo DT, Devanathan AS, McGee KS, Schmitz JL, Sebastian J, Ferrari G, McKellar M, Fiscus SA, Hicks CB, Robertson K, Kashuba ADM, Eron JJ and Margolis DM. Efficacy, Pharmacokinetics and Neurocognitive Performance of Dual, NRTI-Sparing Antiretroviral Therapy in Acute HIV-Infection. . AIDS.[In press]. 2020.

Hill LM, Golin CE, Pack A, Carda-Auten J, Wallace DD, Cherkur S, Farel CE, Rosen EP, Gandhi M, Asher Prince HM and Kashuba ADM. Using Real-Time Adherence Feedback to Enhance Communication About Adherence to Antiretroviral Therapy: Patient and Clinician Perspectives. J. Assoc. Nurses AIDS Care. 31(1):25-34. 2020. PMC6815236.

Khandelwal P, Fukuda T, Teusink-Cross A, Kashuba ADM, Lane A, Mehta PA, Marsh RA, Jordan MB, Grimley MS, Myers KC, Nelson AS, El-Bietar J, Chandra S, Bleesing JJ, Krupski MC and Davies SM. CCR5 inhibitor as novel acute graft versus host disease prophylaxis in children and young adults undergoing allogeneic stem cell transplant: results of the phase II study. Bone Marrow Transplant.:[Epub ahead of print]. 2020.

Lee SA, Telwatte S, Hatano H, Kashuba ADM, Cottrell ML, Hoh R, Liegler TJ, Stephenson S, Somsouk M, Hunt PW, Deeks SG, Yukl S and Savic RM. Antiretroviral Therapy Concentrations Differ in Gut vs. Lymph Node Tissues and Are Associated With HIV Viral Transcription by a Novel RT-ddPCR Assay. J. Acquir. Immune Defic. Syndr. 83(5):530-537. 2020. PMC7286563

Melody K, Roy CN, Kline C, Cottrell ML, Evans D, Shutt K, Pennings PS, Keele BF, Bility M, Kashuba ADM and Ambrose Z. Long-Acting Rilpivirine (RPV) Preexposure Prophylaxis Does Not Inhibit Vaginal Transmission of RPV-Resistant HIV-1 or Select for High-Frequency Drug Resistance in Humanized Mice. J. Virol. 94(8):e01912-01919. 2020. PMC7108851.

Nicol MR, Cottrell ML, Corbett AH, Chinula L, Tegha G, Stanczyk FZ, Hurst S, Kourtis AP and Tang JH. Endogenous Hormones and Antiretroviral Exposure in Plasma, Cervicovaginal Fluid, and Upper-Layer Packed Cells of Malawian Women Living with HIV. AIDS Res. Hum. Retroviruses.[Epub ahead of print]. 2020. PMC7414802

Nixon CC, Mavigner M, Sampey GC, Brooks AD, Spagnuolo RA, Irlbeck DM, Mattingly C, Ho PT, Schoof N, Cammon CG, Tharp GK, Kanke M, Wang Z, Cleary RA, Upadhyay AA, De C, Wills SR, Falcinelli SD, Galardi C, Walum H, Schramm NJ, Deutsch J, Lifson JD, Fennessey CM, Keele BF, Jean S, Maguire S, Liao B, Browne EP, Ferris RG, Brehm JH, Favre D, Vanderford TH, Bosinger SE, Jones CD, Routy JP, Archin NM, Margolis DM, Wahl A, Dunham RM, Silvestri G, Chahroudi A and Garcia JV. Systemic HIV and SIV latency reversal via non-canonical NF-kappaB signalling in vivo. Nature. 578(7793):160-165. 2020. PMC7111210.

Tamraz B, Huang Y, French AL, Kassaye S, Anastos K, Nowicki MJ, Gange S, Gustafson DR, Bacchetti P, Greenblatt RM, Hysi PG and Aouizerat BE. Association of Pharmacogenetic Markers With Atazanavir Exposure in HIV-Infected Women. Clin. Pharmacol. Ther. 107(2):315-318. 2020.

Tang JH, Davis NL, Corbett AH, Chinula L, Cottrell ML, Zia Y, Tegha G, Stanczyk FZ, Hurst S, Hosseinipour MC, Haddad LB and Kourtis AP. Effect of efavirenz on levonorgestrel concentrations among Malawian levonorgestrel implant users for up to 30 months of concomitant use: a subanalysis of a randomized clinical trial. Contraception: X. 2:100027. 2020.

2019

Brocca-Cofano E, Xu C, Wetzel KS, Cottrell ML, Policicchio BB, Raehtz KD, Ma D, Dunsmore T, Haret-Richter GS, Musaitif K, Keele BF, Kashuba AD, Collman RG, Pandrea I, Apetrei C. Marginal Effects of Systemic CCR5 Blockade with Maraviroc on Oral Simian Immunodeficiency Virus Transmission to Infant Macaques. J Virol. 2018 Aug 16;92(17). PMID: 29925666.

Cottrell ML, Prince HMA, Schauer AP, Sykes C, Maffuid K, Poliseno A, Chun TW, Huiting E, Stanczyk FZ, Peery AF, Dellon ES, Adams JL, Gay C, Kashuba ADM. Decreased tenofovir diphosphate concentrations in a transgender female cohort: Implications for HIV pre-exposure prophylaxis (PrEP) Clin Infect Dis. 2019 Apr 9. [Epub ahead of print]. PMID: 30963179. PMC7188232

Davis NL, Corbett A, Kaullen J, Nelson JAE, Chasela CS, Sichali D, Hudgens MG, Miller WC, Jamieson DJ, Kourtis AP. Antiretroviral Drug Concentrations in Breastmilk, Maternal HIV Viral Load, and HIV Transmission to the Infant: Results From the BAN Study. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):467-473. PMID: 30570527. PMC6391211

Dumond JB, Greene SA, Prince HM, Chen J, Maas BM, Sykes C, Schauer AP, Blake KH, Nelson JA, Gay CL, Kashuba AD, Cohen MS. Differential extracellular, but similar intracellular, disposition of two tenofovir formulations in the male genital tract. Antivir Ther. 2019;24(1):45-50. PMID: 30375984. PMC7147147

Ekelöf M, Garrard KP, Judd R, Rosen EP, Xie DY, Kashuba ADM, Muddiman DC. Evaluation of Digital Image Recognition Methods for Mass Spectrometry Imaging Data Analysis. J Am Soc Mass Spectrom. 2018 Dec;29(12):2467-2470. PMID: 30324263. PMCID: PMC6250575.

Garrett KL, Chen J, Maas BM, Cottrell ML, Prince HA, Sykes C, Schauer AP, White N, Dumond JB. A Pharmacokinetic/Pharmacodynamic Model to Predict Effective HIV Prophylaxis Dosing Strategies for People Who Inject Drugs. J Pharmacol Exp Ther. 2018 Nov;367(2):245-251. PMID: 30150483. PMC6170970

Greene S, Chen S, Prince HMA, Sykes C, Schauer AP, Blake K, Nelson JAE, Gay C, Cohen MS, Dumond JB. Population Modeling Highlights Drug Disposition Differences between Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in the Blood and Semen. Clin Pharmacol Ther. 2019 Apr 19. [Epub ahead of print]. PMID: 31002391. PMC7079728

Imaz A, Niubó J, Cottrell ML, Perez E, Kashuba ADM, Tiraboschi JM, Morenilla S, Garcia B, Podzamczer D. Seminal Tenofovir Concentrations, Viral Suppression, and Semen Quality With Tenofovir Alafenamide Compared with Tenofovir Disoproxil Fumarate (Spanish HIV/AIDS Research Network, PreEC/RIS 40). Clin Infect Dis. 2018 Dec 18. [Epub ahead of print] PMID: 30561517. PMC6763637

Joseph SB, Kincer LP, Bowman NM, Evans C, Vinikoor MJ, Lippincott CK, Gisslén M, Spudich S, Menezes P, Robertson K, Archin N, Kashuba A, Eron JJ, Price RW, Swanstrom R. HIV-1 RNA Detected in the CNS after Years of Suppressive Antiretroviral Therapy Can Originate from a Replicating CNS Reservoir or Clonally Expanded Cells. Clin Infect Dis. 2018 Dec 18. [Epub ahead of print] PMID: 30561541. PMC6938202

Kourtis AP, Wiener J, Hurst S, Nelson JAE, Cottrell ML, Corbett A, Chinula L, Msika A, Haddad LB, Tang JH. HIV shedding in the female genital tract of women on ART and progestin contraception: Extended follow-up results of a randomized clinical trial. J Acquir Immune Defic Syndr. In press. PMC6527128

Kovarova M, Benhabbour SR, Massud I, Spagnuolo RA, Skinner B, Baker CE, Sykes C, Mollan KR, Kashuba ADM, García-Lerma JG, Mumper RJ, Garcia JV Ultra-long-acting removable drug delivery system for HIV treatment and prevention. Nat Commun. 2018 Oct 8;9(1):4156. PMID: 30297889. PMC6175887

Krovi SA, Gallovic MD, Keller AM, Bhat M, Tiet P, Chen N, Collier MA, Gurysh EG, Pino EN, Johnson MM, Shamim Hasan Zahid M, Cottrell ML, Pirone JR, Kashuba AD, Kwiek JJ, Bachelder EM, Ainslie KM. Injectable long-acting human immunodeficiency virus antiretroviral prodrugs with improved pharmacokinetic profiles. Int J Pharm. 2018 Dec 1;552(1-2):371-377. PMID: 30308272. PMC6583897

Mavigner M, Habib J, Deleage C, Rosen E, Mattingly C, Bricker K, Kashuba A, Amblard F, Schinazi RF, Lawson B, Vanderford TH, Jean S, Cohen J, McGary C, Paiardini M, Wood MP, Sodora DL, Silvestri G, Estes J, Chahroudi A. Simian Immunodeficiency Virus Persistence in Cellular and Anatomic Reservoirs in Antiretroviral Therapy-Suppressed Infant Rhesus Macaques. J Virol. 2018 Aug 29;92(18). PMID: 29997216. PMC6340051

McRae MP, Leibrand C, Jones A, Paris J, Masuda Q, Halquist M, Kim WK, Knapp P, Kashuba A, Hauser K. HIV-1 Tat and opioids act independently to limit antiretroviral brain concentrations and reduce blood-brain barrier integrity. Journal of NeuroVirology. In press. PMC6750988

Medina-Moreno S, Zapata JC, Cottrell ML, Le NM, Tao S, Bryant J, Sausville E, Schinazi RF, Kashuba AD, Redfield RR, Heredia A. Disparate effects of cytotoxic chemotherapy on the antiviral activity of antiretroviral therapy: implications for treatments of HIV-infected cancer patients. Antivir Ther. 2018 Dec 21. [Epub ahead of print] PMID: 30574873. PMC6779049

Mitchell JT, LeGrand S, Hightow-Weidman LB, McKellar MS, Kashuba AD, Cottrell M, McLaurin T, Satapathy G, McClernon FJ. Smartphone-Based Contingency Management Intervention to Improve Pre-Exposure Prophylaxis Adherence: Pilot Trial. JMIR Mhealth Uhealth. 2018 Sep 10;6(9):e10456. PMID: 30201601. PMC6231728

Nicol MR, Corbino JA, Cottrell ML. Pharmacology of Antiretrovirals in the Female Genital Tract for HIV Prevention. J Clin Pharmacol. 2018 Nov;58(11):1381-1395. PMID: 29901863. PMC6333200

Pack AP, Golin CE, Hill LM, Carda-Auten J, Wallace DD, Cherkur S, Farel CE, Rosen EP, Gandhi M, Asher Prince HM, Kashuba ADM. Patient and clinician perspectives on optimizing graphical displays of longitudinal medication adherence data. Patient Educ Couns. 2019 Jan 2. [Epub ahead of print] PMID: 30626550. PMC6525638

Rudolph JE, Cole SR, Eron JJ, Kashuba AD, Adimora AA. Estimating human immunodeficiency virus (HIV) prevention effects in low-incidence settings. Epidemiology. 2019 Jan 10. [Epub ahead of print] PMID: 30640216. PMC6456405

Shen Z, Rodriguez-Garcia M, Patel MV, Bodwell J, Wira CR. Epithelial Cells and Fibroblasts from the Human Female Reproductive Tract Accumulate and Release TFV and TAF to Sustain Inhibition of HIV Infection of CD4+ T cells. Sci Rep. 2019 Feb 12;9(1):1864. PMID: 30755713. PMC6372694

Srinivas N, Joseph SB, Robertson K, Kincer LP, Menezes P, Adamson L, Schauer AP, Blake KH, White N, Sykes C, Luciw P, Eron JJ, Forrest A, Price RW, Spudich S, Swanstrom R, Kashuba ADM. Predicting Efavirenz Concentrations in the Brain Tissue of HIV-Infected Individuals and Exploring their Relationship to Neurocognitive Impairment. Clin Transl Sci. 2019 Jan 24. [Epub ahead of print] PMID: 30675981. PMC6510381

Srinivas N, Rosen EP, Gilliland WM Jr, Kovarova M, Remling-Mulder L, De La Cruz G, White N, Adamson L, Schauer AP, Sykes C, Luciw P, Garcia JV, Akkina R, Kashuba ADM. Antiretroviral concentrations and surrogate measures of efficacy in the brain tissue and CSF of preclinical species. 2018 Dec 17:1-10. [Epub ahead of print] PMID: 30346892. PMC6579712

Srinivas N, Maffuid K, Kashuba ADM. Clinical Pharmacokinetics and Pharmacodynamics of Drugs in the Central Nervous System. Clin Pharmacokinet. 2018 Sep;57(9):1059-1074. PMID: 29464550 PMC6062484

Sykes C, Blake K, White N, Schauer AP, Guzman BB, Cottrell ML, Tamraz B, Kashuba ADM. Development and validation of an LC-MS/MS assay for the quantification of dolutegravir extracted from human hair. Anal Bioanal Chem. 2018 Nov;410(29):7773-7781. PMID: 30280227. PMC6501839

Thurman AR, Schwartz JL, Brache V, Chen BA, Chandra N, Kashuba ADM, Weiner DH, Mauck C, Doncel GF. Effect of Hormonal Contraception on Pharmacokinetics of Vaginal Tenofovir in Healthy Women: Increased Tenofovir Diphosphate in Injectable Depot Medroxyprogesterone Acetate Users. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):79-88. PMID: 30212395.

2018

Archin NM, Kirchherr JL, Sung JA, Clutton G, Sholtis K, Xu Y, Allard B, Stuelke E, Kashuba AD, Kuruc JD, Eron J, Gay CL, Goonetilleke N, Margolis DM. Interval dosing with the HDAC inhibitor vorinostat effectively reverses HIV latency. J Clin Invest. 2017 Aug 1;127(8):3126-3135. PMID number: 28714868. PMCID number: PMC5531421.

Asmuth DM, Thompson CG, Chun TW, Ma ZM, Mann S, Sainz T, Serrano-Villar S, Utay NS, Garcia JC, Troia-Cancio P, Pollard RB, Miller CJ, Landay A, Kashuba AD. Tissue Pharmacologic and
Virologic Determinants of Duodenal and Rectal Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution in HIV-Infected Patients Initiating Antiretroviral Therapy. J Infect Dis. 2017 Oct17;216(7):813-818 PMID number: 28968888. PMCID: PMC6279130 

Barbian HJ, Jackson-Jewett R, Brown CS, Bibollet-Ruche F, Learn GH, Decker T, Kreider EF, Li Y, Denny TN, Sharp PM, Shaw GM, Lifson J, Acosta E, Saag MS, Bar KJ, Hahn BH. Effective treatment of SIVcpz-induced immunodeficiency in a captive western chimpanzee. Retrovirology. 2017 Jun 2;14(1):35. PMID number: 28576126. PMCID number: PMC5457593.

Brooks KM, Garrett KL, Kuriakose SS, George JM, Balba G, Bailey B, Anderson M, Lane HC, Maldarelli F, Pau AK. Decreased Absorption of Dolutegravir and Tenofovir Disoproxil Fumarate, But
Not Emtricitabine, in an HIV-Infected Patient Following Oral and Jejunostomy-Tube Administration. Pharmacotherapy. 2017 Aug;37(8):e82-e89. PMID number: 28556353. PMCID number: PMC5559318.

Brooks KM, George JM, Pau AK, Rupert A, Mehaffy C, De P, Dobos KM, Kellogg A, McLaughlin M, McManus M, Alfaro RM, Hadigan C, Kovacs JA, Kumar P. Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir with Once-Weekly Isoniazid and Rifapentine. Clin Infect Dis. 2018 Feb 3. [Epub ahead of print] PMID number: 29415190. PMCID: PMC6248641

Chen J, Akhtari FS, Wagner MJ, Suzuki O, Wiltshire T, Motsinger-Reif AA, Dumond JB. Pharmacogenetic Analysis of the Model-Based Pharmacokinetics of Five Anti-HIV Drugs: How Does
This Influence the Effect of Aging? Clin Transl Sci (2017) 00, 1–12. PMID number: 29205871. PMCID number: PMC5866997.

Eke AC, Chakhtoura N, Kashuba A, Best BM, Sykes C, Wang J, Stek AM, Smith E, Calabrese S, Capparelli EV, Mirochnick M; IMPAACT P1026s Protocol Team. Rilpivirine Plasma and Cervico-Vaginal Concentrations in Women During Pregnancy and Postpartum. J Acquir Immune Defic Syndr. 2018 Mar 8 [Epub ahead of print] PMID number: 29528944. PMCID: PMC6002878

Feder AF, Kline C, Polacino P, Cottrell M, Kashuba ADM, Keele BF, Hu SL, Petrov DA, Pennings PS, Ambrose Z. A spatio-temporal assessment of simian/human immunodeficiency virus (SHIV) evolution reveals a highly dynamic process within the host. PLoS Pathog. 2017 May 25;13(5):e1006358. PMID number: 28542550. PMCID number: PMC5444849.

Kumar A, Smith CEP, Giorgi EE, Eudailey J, Martinez DR, Yusim K, Douglas AO, Stamper L, McGuire E, LaBranche CC, Montefiori DC, Fouda GG, Gao F, Permar SR. Infant Transmitted/Founder HIV-1 Viruses from Peripartum Transmission are Neutralization Resistant to Paired Maternal Plasma. PLoS Pathog. 2018 Apr 19;14(4):e1006944. PMID number: 29672607. PMCID: PMC5908066 

McKinnon LR, Liebenberg LJ, Yende-Zuma N, Archary D, Ngcapu S, Sivro A, Nagelkerke N, Garcia Lerma JG, Kashuba AD, Masson L, Mansoor LE, Karim QA, Karim SSA, Passmore JS. Genital
inflammation undermines the effectiveness of tenofovir gel in preventing HIV acquisition in women. Nat Med. 2018 May;24(4):491-496. PMID number: 29480895. PMCID number: PMC5893390.

Nicol MR, Brewers LM, Kashuba ADM, Sykes C. The role of menopause in tenofovir diphosphate and emtricitabine triphosphate concentrations in cervical tissue. AIDS. 2018 Jan 2;32(1):11-15. PMID number: 29112071.

Rodriguez-Garcia M, Patel MV, Shen Z, Bodwell J, Rossoll RM, Wira CR. Tenofovir Inhibits Wound Healing of Epithelial Cells and Fibroblasts from the Upper and Lower Human Female Reproductive Tract. Sci Rep. 2017 Apr 3;8:45725. PMID number: 28368028. PMCID number: PMC5377941.

Schauer AP, Sykes C, Cottrell ML, Prince H, Kashuba ADM. Validation of an LC-MS/MS assay to simultaneously monitor the intracellular active metabolites of tenofovir, emtricitabine, and lamivudine in dried blood spots. J Pharm Biomed Anal. 2018 Feb 5;149:40-45. PMID number: 29100029. PMCID number: PMC5741486.

Shen Z, Rodriguez-Garcia M, Patel MV, Bodwell J, Kashuba ADM, Wira CR.Hormonal Contraceptives Differentially Suppress TFV and TAF Inhibition of HIV Infection and TFV-DP in Blood and Genital Tract CD4+ T cells. Sci Rep. 2017 Dec 18;7(1):17697. PMID number: 29255206. PMCID number: PMC5735186.

Sneller MC, Justement JS, Gittens KR, Petrone ME, Clarridge KE, Proschan MA, Kwan R, Shi V, Blazkova J, Refsland EW, Morris DE, Cohen KW, McElrath MJ, Xu R, Egan MA, Eldridge JH, Benko E, Kovacs C, Moir S, Chun TW, Fauci AS. A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection. Sci Transl Med. 2017 Dec 6;9(419). PMID number: 29212716.

Thompson CG, Fallon JK, Mathews M, Charlins P, Remling-Mulder L, Kovarova M, Adamson L, Srinivas N, Schauer A, Sykes C, Luciw P, Garcia JV, Akkina R, Smith PC, Kashuba ADM. Multimodal analysis of drug transporter expression in gastrointestinal tissue. AIDS. 2017 Jul 31;31(12):1669-1678. PMID number: 28590331. PMCID number: PMC5546623.

Thompson CG, Gay CL, Kashuba ADM. HIV Persistence in Gut-Associated Lymphoid Tissues: Pharmacological Challenges and Opportunities. AIDS Res Hum Retroviruses. 2017 Jun;33(6):513-523. PMID number: 28398774. PMCID number: PMC5467125.

Thurman AR, Chandra N, Yousefieh N, Kimble T, Anderson SM, Cottrell M, Sykes C, Kashuba A, Schwartz JL, Doncel GF.Differences in Local and Systemic Tenofovir Pharmacokinetics among
Premenopausal versus Postmenopausal Women exposed to Tenofovir 1% Vaginal Gel. J Acquir Immune Defic Syndr. 2018 Feb 7. PMID number: 29424790. PMCID: PMC5902131 

2017

Dumond JB, Collins JW, Cottrell ML, Trezza CR, Prince H, Sykes C, Torrice C, White N, Malone S, Wang R, Patterson KB, Sharpless NE, Forrest A. p16<sup>INK4a</sup> , a Senescence Marker, Influences Tenofovir/Emtricitabine Metabolite Disposition in HIV-Infected Subjects. CPT Pharmacometrics Syst Pharmacol. 2017 Feb;6(2):120-127. doi: 10.1002/psp4.12150.

Thompson CG, Gay CL, Kashuba ADM. HIV Persistence in Gut Associated Lymphoid Tissues: Pharmacological Challenges and Opportunities. AIDS Res Hum Retroviruses. 2017 Jun;33(6):513-523. doi: 10.1089/AID.2016.0253.

Wahl A, Ho PT, Denton PW, Garrett KL, Hudgens MG, Swartz G, O’Neill C, Veronese F, Kashuba AD, Garcia JV. Predicting HIV Pre-exposure Prophylaxis Efficacy for Women using a Preclinical Pharmacokinetic-Pharmacodynamic In Vivo Model. Sci Rep 2017 Feb 1;7:41098. doi: 10.1038/srep41098.

The role of menopause in tenofovir diphosphate and emtricitabine triphosphate concentrations in cervical tissue. Nicol MR, Brewers LM, Kashuba AD, Sykes C. AIDS. 2017 Nov 2. doi: 10.1097/QAD.0000000000001678. [Epub ahead of print] PMID: 29112071

Validation of an LC-MS/MS assay to simultaneously monitor the intracellular active metabolites of tenofovir, emtricitabine, and lamivudine in dried blood spots. Schauer AP, Sykes C, Cottrell ML, Prince H, Kashuba ADM. J Pharm Biomed Anal. 2017 Oct 31;149:40-45. doi: 10.1016/j.jpba.2017.10.030. [Epub ahead of print] PMID: 29100029

Tissue Pharmacologic and Virologic Determinants of Duodenal and Rectal Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution in HIV-Infected Patients Initiating Antiretroviral Therapy. Asmuth DM, Thompson CG, Chun TW, Ma ZM, Mann S, Sainz T, Serrano Villar S, Utay NS, Garcia JC, Troia-Cancio P, Pollard RB, Miller CJ, Landay A, Kashuba AD. J Infect Dis. 2017 Oct 17;216(7):813-818. doi: 10.1093/infdis/jix418. PMID: 28968888

Interval dosing with the HDAC inhibitor vorinostat effectively reverses HIV latency. Archin NM, Kirchherr JL, Sung JA, Clutton G, Sholtis K, Xu Y, Allard B, Stuelke E, Kashuba AD, Kuruc JD, Eron J, Gay CL, Goonetilleke N, Margolis DM. J Clin Invest. 2017 Aug 1;127(8):3126-3135. doi: 10.1172/JCI92684. Epub 2017 Jul 17. PMID: 28714868

A spatio-temporal assessment of simian/human immunodeficiency virus (SHIV) evolution reveals a highly dynamic process within the host. Feder AF, Kline C, Polacino P, Cottrell M, Kashuba ADM, Keele BF, Hu SL, Petrov DA, Pennings PS, Ambrose Z. PLoS Pathog. 2017 May 25;13(5):e1006358. doi: 10.1371/journal.ppat.1006358. eCollection 2017 May. PMID: 28542550

Co-trimoxazole Prophylaxis, Asymptomatic Malaria Parasitemia, and Infectious Morbidity in Human Immunodeficiency Virus-Exposed, Uninfected Infants in Malawi: The BAN Study. Davis NL, Wiener J, Juliano JJ, Adair L, Chasela CS, Kayira D, Hudgens MG, van der Horst C, Jamieson DJ, Kourtis AP; Breastfeeding, Antiretrovirals and Nutrition (BAN) Study Team; Breastfeeding, Antiretrovirals and Nutrition (BAN) Study Team. Clin Infect Dis. 2017 Aug 15;65(4):575-580. doi: 10.1093/cid/cix367. PMID: 28444232

Predicting HIV Pre-exposure Prophylaxis Efficacy for Women using a Preclinical Pharmacokinetic Pharmacodynamic In Vivo Model. Wahl A, Ho PT, Denton PW, Garrett KL, Hudgens MG, Swartz G, O’Neill C, Veronese F, Kashuba AD, Garcia JV. Sci Rep. 2017 Feb 1;7:41098. doi: 10.1038/srep41098. PMID: 28145472

Elvitegravir concentrations in seminal plasma in HIV-1-infected men. Imaz A, Niubó J, Kashuba AD, Ferrer E, Sykes C, Rozas N, Acerete L, Vila A, Podzamczer D. HIV Med. 2017 Mar;18(3):225 230. doi: 10.1111/hiv.12417. Epub 2016 Aug 1. PMID: 27477062

2015

Abdool Karim SS, Abdool Karim Q, Kharsany AB, Baxter C, Grobler AC, Werner L, Kashuba A, Mansoor LE, Samsunder N, Mindel A, Gengiah TN; CAPRISA 004 Trial Group. Tenofovir Gel for the Prevention of Herpes Simplex Virus Type 2 Infection. N Engl J Med. 2015 Aug 6;373(6):530-9. doi: 10.1056/NEJMoa1410649. PubMed PMID: 26244306; PubMed Central PMCID: PMC4562018.

Agot K, Taylor D, Corneli AL, Wang M, Ambia J, Kashuba AD, Parker C, Lemons A, Malahleha M, Lombaard J, Van Damme L. Accuracy of Self-Report and Pill-Count Measures of Adherence in the FEM-PrEP Clinical Trial: Implications for Future HIV-Prevention Trials. AIDS Behav. 2015 May;19(5):743-51. doi: 10.1007/s10461-014-0859-z. PubMed PMID: 25100053; PubMed Central PMCID: PMC4415940.

Bokhart MT, Rosen E, Thompson C, Sykes C, Kashuba AD, Muddiman DC. Quantitative Mass Spectrometry Imaging of Emtricitabine in Cervical Tissue Model using Infrared Matrix-Assisted Laser Desorption Electrospray Ionization. Anal Bioanal Chem 407:2073-2084. 2015. PMID:25318460.

Corneli A, McKenna K, Perry B, Ahmed K, Agot K, Malamatsho F, Skhosana J, Odhiambo J, Van Damme L. The Science of being a Study Participant: FEM-PrEP Participants’ Explanations for Over-Reporting Adherence to the Study Pills and on the Whereabouts of Unused Pills. Journal of Acquired Immune Deficiency Syndromes 68:578-584. 2015. PMID:25761233.

Cottrell ML, Patterson KB, Prince HM, Jones A, White N, Wang R, Kashuba AD. Effect of HIV infection and menopause status on raltegravir pharmacokinetics in the blood and genital tract. Antivir Ther. 2015 Jun 3. doi: 10.3851/IMP2968. [Epub ahead of print] PubMed PMID: 26040011.

Cottrell ML, Srinivas N, Kashuba AD. Pharmacokinetics of antiretrovirals in mucosal tissue. Expert Opin Drug Metab Toxicol. 2015 Jun;11(6):893-905. doi: 10.1517/17425255.2015.1027682. Epub 2015 Mar 22. PubMed PMID: 25797064; PubMed Central PMCID: PMC4498566.

Daniels KR, Juday TR, Jones X, Labreche MJ, Koeller JM, Seekins DW, Oramasionwu CU, Bollinger M, Copeland LA, Mortensen EM, Frei CR. Comparative Value of Four Measures of Retention in Expert Care in Predicting Clinical Outcomes and Health Care Utilization in HIV Patients. PLoS One. 2015 Mar 20;10(3):e0120953. PMID: 25794182 PMCID: PMC4368570

Dumond JB, Rigdon J, Mollan K, Tierney C, Kashuba AD, Aweeka F, Collier AC. Significant Decreases in both Total and Unbound Lopinavir and Amprenavir Exposures during Co-administration: ACTG Protocol A5143/A5147s Results. J Acquir Immune Defic Syndr. 2015 Jul 30. [Epub ahead of print] PubMed PMID: 26230332.

Dumond JB, Yang KH, Kendrick R, Reddy YS, Kashuba AD, Troiani L, Bridges AS, Fiscus SA, Forrest A, Cohen MS. Pharmacokinetic Modeling of Lamivudine and Zidovudine Triphosphates Predicts Differential Pharmacokinetics in Seminal Mononuclear Cells and Peripheral Blood Mononuclear Cells. Antimicrob Agents Chemother. 2015 Oct;59(10):6395-401. doi: 10.1128/AAC.01148-15. Epub 2015 Aug 3. PubMed PMID: 26239974; PubMed Central PMCID: PMC4576057.

Flax VL, Adair LS, Allen LH, Shahab-Ferdows S, Hampel D, Chasela CS, Tegha G, Daza EJ, Corbett A, Davis NL, Kamwendo D, Kourtis AP, van der Horst CM, Jamieson DJ, Bentley ME; BAN Study Team. Plasma Micronutrient Concentrations Are Altered by Antiretroviral Therapy and Lipid-Based Nutrient Supplements in Lactating HIV-Infected Malawian Women. J Nutr. 2015 Aug;145(8):1950-7. doi: 10.3945/jn.115.212290. Epub 2015 Jul 8. PubMed PMID: 26156797; PubMed Central PMCID: PMC4516772.

Floris-Moore MA, Mollan K, Wilkin AM, Johnson MA, Kashuba AD, Wohl DA, Patterson KB, Francis O, Kronk C, Eron JJ. Antiretroviral activity and safety of once-daily etravirine in treatment-naive HIV-infected adults: 48-week results. Antivir Ther. 2015 Aug 11. doi: 10.3851/IMP2982. [Epub ahead of print] PubMed PMID: 26263403.

Gao Y, Yuan A, Chuchuen O, Ham A, Yang KH, Katz DF. Vaginal deployment and tenofovir delivery by microbicide gels. Drug Deliv Transl Res. 2015 Jun;5(3):279-94. doi: 10.1007/s13346-015-0227-1. PubMed PMID: 25874971; PubMed Central PMCID: PMC4420798.

Grant RM, Liegler T, Defechereux P, Kashuba AD, Taylor D, Abdel-Mohsen M, Deese J, Fransen K, De Baetselier I, Crucitti T, Bentley G, Agingu W, Ahmed K, Damme LV. Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. AIDS. 2015 Jan 28;29(3):331-7. PubMed PMID: 25503265.

Hendrix CW, Andrade A, Bumpus NN, Kashuba AD, Marzinke MA, Moore A, Anderson PL, Bushman LR, Fuchs EJ, Wiggins I, Radebaugh C, Prince HA, Bakshi RP, Wang R, Richardson P, Shieh E, McKinstry L, Li X, Donnell D, Elharrar V, Mayer KH, Patterson KB. Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retroviruses. 2015 Oct 15. [Epub ahead of print] PubMed PMID: 26414912.

Joseph SB, Swanstrom R, Kashuba AD, Cohen MS. Bottlenecks in HIV-1 transmission: insights from the study of founder viruses. Nat Rev Microbiol. 2015 Jul;13(7):414-25. doi: 10.1038/nrmicro3471. Epub 2015 Jun 8. Review. PubMed PMID: 26052661.

Kashuba AD, Gengiah TN, Werner L, Yang KH, White NR, Karim QA, Abdool Karim SS. Genital Tenofovir Concentrations Correlate With Protection Against HIV Infection in the CAPRISA 004 Trial: Importance of Adherence for Microbicide Effectiveness. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):264-9. doi: 10.1097/QAI.0000000000000607. PubMed PMID: 26181703; PubMed Central PMCID: PMC4505741.

Maher JR, Chuchuen O, Henderson MH, Kim S, Rinehart MT, Kashuba AD, Wax A, Katz DF. Co-localized confocal Raman spectroscopy and optical coherence tomography (CRS-OCT) for depth-resolved analyte detection in tissue. Biomed Opt Express. 2015 May 8;6(6):2022-35. doi: 10.1364/BOE.6.002022. eCollection 2015 Jun 1. PubMed PMID: 26114026; PubMed Central PMCID: PMC4473741.

Meditz AL, C Palmer, J Predhomme, K Searls, B Kerr, S Seifert, P Caraway, E Gardner, S MaWhinney, Anderson PL. Relationship between Genital Drug Concentrations and Cervical Cellular Immune Activation and Reconstitution in HIV-1 Infected Women on a Raltegravir Versus a Boosted Atazanavir Regimen. AIDS Research and Human Retroviruses June 10, 2015. epub ahead of print:PMID: 26061027.

Melody K, McBeth S, Kline C, Kashuba AD, Mellors JW, Ambrose Z. Low Frequency of Drug Resistant Variants Selected by Long Acting Rilpivirine (RPV LA) in Macaques Infected with RT-SHIV. Antimicrob Agents Chemother. 2015 Oct 5. pii: AAC.01937-15. [Epub ahead of print] PubMed PMID: 26438501.

Nicol MR, Emerson CW, Prince HM, Nelson JA, Fedoriw Y, Sykes C, Geller EJ, Patterson KB, Cohen MS, Kashuba AD. Models for predicting effective HIV chemoprevention in women. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):369-76. doi: 10.1097/QAI.0000000000000472. PubMed PMID: 25501616; PubMed Central PMCID: PMC4334725.

Oramasionwu CU, Bailey SC, Johnson TL, Mao L. Engagement in outpatient care for patients living with HIV (PLWH). AIDS Res Hum Retroviruses. 2015 Feb;31(2):177-82. doi: 10.1089/aid.2014.0049.

Peterson CW, Haworth KG, Polacino P, Huang ML, Sykes C, Obenza WM, Repetto AC, Kashuba ADM, Bumgarner R, DeRosa SC, Woolfrey AE, Jerome KR, Mullins JI, Hu SL, Kiem HP. Lack of Viral Control and Development of cART Escape Mutations in Macaques After Bone Marrow Transplantation. AIDS In press 2015.

Rahangdale L, De Paris K, Kashuba AD, Nelson JA, Cottrell M, Sykes C, Emerson C, Young SL, Stevens T, Patterson KB, Cohen MS. Immunologic, virologic, and pharmacologic characterization of the female upper genital tract in HIV-infected women. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):420-4. doi: 10.1097/QAI.0000000000000480. PubMed PMID: 25501615; PubMed Central PMCID: PMC4334681.

Ramlal RT, Tembo M, King CC, Ellington S, Soko A, Chigwenembe M, Chasela C, Jamieson DJ, van der Horst C, Bentley M, Adair L, BAN Study T. Dietary Patterns and Maternal Anthropometry in HIV-Infected, Pregnant Malawian Women. Nutrients 7:584-594. 2015. PMID:25594441. PMCID: PMC4303855.

Reveles KR, Juday TR, Jones X, Labreche MJ, Koeller JM, Seekins DW, Oramasionwu CU, Bollinger M, Copeland LA, Mortensen EM, Frei CR. Comparative value of four measures of retention in expert care in predicting clinical outcomes and health care utilization in HIV patients. PLoS One. 2015 Mar 20;10(3):e0120953. doi: 10.1371/journal.pone.0120953. eCollection 2015.

Sabo JP, Kort J, Ballow C, Kashuba AD, Haschke M, Battegay M, Girlich B, Ting N, Lang B, Zhang W, Cooper C, O’Brien D, Seibert E, Chan TS, Tweedie D, Li Y. Interactions of the Hepatitis C Virus Protease Inhibitor Faldaprevir with Cytochrome P450 Enzymes: In Vitro and in Vivo Correlation. J Clin Pharmacol 55:467-477. 2015. PMID:25449227.

Sellers CJ, Lee H, Chasela C, Kayira D, Soko A, Mofolo I, Ellington S, Hudgens MG, Kourtis AP, King CC, Jamieson DJ, van der Horst C; BAN Study Team. Reducing lost to follow-up in a large clinical trial of prevention of mother-to-child transmission of HIV: the Breastfeeding, Antiretrovirals and Nutrition study experience. Clin Trials. 2015 Apr;12(2):156-65. doi: 10.1177/1740774514562031. Epub 2014 Dec 17. PubMed PMID: 25518956; PubMed Central PMCID: PMC4355163.

Smith NM, Mlcochova P, Watters SA, Aasa-Chapman MM, Rabin N, Moore S, Edwards SG, Garson JA, Grant PR, Ferns RB, Kashuba A, Mayor NP, Schellekens J, Marsh SG, McMichael AJ, Perelson AS, Pillay D, Goonetilleke N, Gupta RK. Proof-of-Principle for Immune Control of Global HIV-1 Reactivation In Vivo. Clin Infect Dis. 2015 Jul 1;61(1):120-8. doi: 10.1093/cid/civ219. Epub 2015 Mar 16. PubMed PMID: 25778749; PubMed Central PMCID: PMC4463006.

Thompson CG, Bokhart MT, Sykes C, Adamson L, Fedoriw Y, Luciw PA, Muddiman DC, Kashuba AD, Rosen EP. Mass spectrometry imaging reveals heterogeneous efavirenz distribution within putative HIV reservoirs. Antimicrob Agents Chemother. 2015 May;59(5):2944-8. doi: 10.1128/AAC.04952-14. Epub 2015 Mar 2. PubMed PMID: 25733502; PubMed Central PMCID: PMC4394831.

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Pharmacology Training Table of Contents
Training CategoryModule TitleDurationVideo Link
OverviewWhat is Pharmacokinectics12:20https://vimeo.com/220303663
OverviewART in older patients11:02https://vimeo.com/227701376
OverviewThe Pharmacology of PrEP11:51https://vimeo.com/227701454
AbsorptionPrinciples of Absorption14:20https://vimeo.com/220988942
DispositionPrinciples of Disposition12:22https://vimeo.com/220988985
Metabolism and ExcretionPrinciples of Drug Metabolism and Excretion12:57https://vimeo.com/220989054
Class Specific PharmacologyDisposition of NNRTIs15:26https://vimeo.com/230905734
Class Specific PharmacologyDisposition of NRTIs16:54https://vimeo.com/230905755
Class Specific PharmacologyDisposition of PIs and boosting14:43https://vimeo.com/230905768
Population PK and ModelingInter and Intra-variability in PK11:02https://vimeo.com/220309797
Population PK and ModelingPopulation Pharmacokinectics14:01https://vimeo.com/227701441
Population PK and ModelingPBPK Modeling10:11https://vimeo.com/229706801
Drug InteractionsThe Basics of Drug Drug Interactions12:28https://vimeo.com/220309881
Drug InteractionsAbsorption Interactions11:56https://vimeo.com/236571317
Drug InteractionsRenal Interactions9:20https://vimeo.com/236571344
Drug InteractionsRenal and Hepatic Interactions7:51https://vimeo.com/236571316
Drug InteractionsMetabolic Interactions11:04https://vimeo.com/236571334
Drug InteractionsDrug Interactions in an Aging HIV Population11:01https://vimeo.com/227701287