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Goals

The broad, long-term objectives of the Clinical Pharmacology and Analytical Chemistry Core are to provide a full spectrum of pharmacologic support for HIV/AIDS-related research of the UNC CFAR. Members of the Clinical Pharmacology and Analytical Chemistry Core proactively engage UNC CFAR investigators to identify and deliver services essential for highly productive design, management, analysis and publication of HIV/AIDS research. The Core contributes to the framing of hypotheses, development of study designs, preparation of grant applications, selection or creation of best analytical chemistry and pharmacometric methods, facilitating multidisciplinary and translational approaches to the design of and conduct of clinical studies, and delivery of preclinical or clinical analyses.

Investigators new to HIV/AIDS research receive highest priority for Core services. Strong institutional support from the School of Pharmacy allows the Core to take full advantage of existing infrastructure, resources and contacts with faculty renowned for their expertise in specialized fields of pharmacology. The Core supports drug quantification in a variety of matrices with 6 AB Sciex 5000 Triple Quadrupole Mass connected to Shimadzu HPLC systems running on Analyst software and an infrared matrix assisted laser desorption electrospray ionization (IR-MALDESI) imaging source coupled to a Thermo QExactive/H-ESI II Bundle mass spectrometer similar to that housed in the inventor of this technology’s laboratory (David Muddiman, North Carolina State University).

CPAC Laboratory Aims

Aim 1: Provide access to a diverse array of cost-effective services for pharmacology research.

Aim 2: Stimulate, develop and disseminate new innovative technologies and services to enhance HIV/AIDS research.

Aim 3: Support priority CFAR initiatives and goals and collaborative research.

Aim 4: Develop and promote synergistic relationships between the UNC CFAR Cores and Working Groups, and other CFAR.

Aim 5: Provide clinical pharmacology, pharmacometric, and analytical chemistry training, mentoring, and education, and outreach.

Aim 6: Engage in evaluation and strategic planning.

CPAC Validates Novel Assay to Measure Antiretrovirals in Dried Blood Spot for Adherence Monitoring

The Clinical Pharmacology Core has recently developed and validated a sensitive, multiplex LC-MS/MS assay to measure the intracellular metabolites of the 3 most commonly prescribed NRTIs (tenofovir, emtricitabine, and lamivudine) in dried blood spots collected from patients on therapy. This assay allows investigators to monitor adherence in clinical trials with the convenience of dried blood spot sampling, storage and shipping. The addition of lamivudine, which is generically available, opens up opportunity for international investigations. Our methods and findings are in press in the Journal of Pharmaceutical and Biomedical Analysis (Schauer et al. Validation of an LC-MS/MS Assay to Simultaneously Monitor the Intracellular Active Metabolites of Tenofovir, Emtricitabine, and Lamivudine in Dried Blood Spots. JPBA. In press).

Acknowledgement, Recognition and Future Service

All work provided by the UNC CFAR Clinical Pharmacology and Analytical Chemistry Core which is included in a publication should acknowledge the contribution of the Core. Proper acknowledgment enables us to obtain financial and other support so that we can continue to provide essential services in the best ways possible. It would be appreciated if you sent a copy of the accepted manuscript, published paper, or title of grant application to mlcottre@email.unc.edu. This will allow us to demonstrate our impact to the research community.

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 Center for AIDS Research Clinical Pharmacology and Analytical Chemistry Core, and director of the Analytical Chemistry Laboratory for the Verne S. Caviness General Clinical Research Center. She is a diplomat of the American Board of Clinical Pharmacology. Research Kashuba’s research interests focus on the clinical pharmacology of antiretroviral agents used in the treatment of HIV infection. Specifically, she is investigating the role of antiretroviral therapy in preventing the transmission of HIV, determining optimal dosing and drug combinations for the treatment of HIV infection, understanding and predicting drug-drug and drug-cytokine interactions and adverse effects, and role of sex and ethnicity in drug disposition.

3318 Kerr Hall
CB# 7569
Chapel Hill, NC
akashuba@unc.edu
Fax: 919-962-0644
Office Phone: 919-966-9998

Mackenzie Cottrell, Pharm.D., MS

Assistant Core Director

 

Mackenzie Cottrell is a Research Assistant Professor in the Division of Pharmacotherapy and Experimental Therapeutics at UNC Eshelman School of Pharmacy. She is a Board Certified Pharmacotherapy Specialist and an American Academy of HIV Medicine™ accredited HIV Pharmacist. Her research focuses on describing pharmacokinetic/pharmacodynamic relationships in mucosal tissues for antiretrovirals being used in HIV prevention and cure interventions.

 

mlcottre@email.unc.edu
Office Phone: 919-843-7806

Elias Rosen, Ph.D.

Imaging Mass Spectrometry Scientist

rosen

 

Elias Rosen’s research focuses on the development of methods to measure intracellular distribution of therapeutics and their metabolites in a variety of biological matrices using mass spectrometry imaging. 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) 966-9998

 

Heather Prince, MPA, PA-C

Clinical Study Specialist

 

Heather Prince joined the UNC CFAR in 2008. She holds an AS and BA in Microbial Genetics from Peace College, and an MPA from Eastern Virginia Medical School. She has completed post-graduate surgical training at Eastern Virginia Medical School, Emory University, Harvard University and John Hopkins University. She is a Certified Clinical Research Professional who oversees all clinical aspects of research studies, from protocol development to implementation and patient care.

 

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

 

Lab Management

John H. Dohnal, BS, MBA

Laboratory Operations Manager

 

John Dohnal joined the UNC CFAR in 2014 and brings 20 years of management and 13 years of quality experience to the Kashuba Lab. Dohnal received a BS in biochemistry from Florida State University and an Executive Masters of Business Administration with concentration in Health Sector Management from the Duke Fuqua School of Business. Dohnal’s focus is ensuring laboratory safety, supervising work study students and interns, sample chain of custody, streamlining laboratory work flows, automation of data processes, creating and maintaining a robust community outreach and social media presence, and continuous improvement in the lab.

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

Hannah Bryan, BS

QA/QC Officer

 

Hannah Bryan holds a BS in Animal Science from NC State University. Prior to joining the UNC CFAR in 2017, she spent six years conducting both discovery and regulated research for a Clinical Research Organization in Research Triangle Park. Hannah currently oversees all quality control aspects of the analytical study data that is generated in the lab.

 

 

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

Research Specialists

Craig Sykes, MS

Bioanalytical Method Development Scientist

Craig Sykes

 

Craig Sykes holds a BS in chemistry from UNC-Wilmington and an MS in analytical chemistry from UNC-Chapel Hill. Prior to joining the UNC CFAR in 2011, he spent nine years developing GLP-compliant assays for several contract research organizations (CROs). He has extensive experience in LC-MS/MS method development, method validation, and sample analysis in a regulated environment. He is responsible for the development and validation of bioanalytical assays for the UNC CFAR.

 

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. White oversees analytical methods and standard operating procedures in the laboratory. She has been with the UNC CFAR since 2007.

 

 

nicole_white@med.unc.edu
Office Phone: 919-843-1016

 

Amanda Schauer, BS

Bioanalytical Research Specialist

 

Amanda Schauer joined the UNC CFAR in January 2015 with a BA in chemistry from NC State University. Before joining UNC in 2015, she worked for a CRO company doing sample analysis and quality control in a GLP-regulated environment. Schauer is responsible for LC-MS/MS analytical methods and sample analysis in the laboratory.

 

 

aps5@email.unc.edu
Office Phone: (919) 966-9998

Brian Van Home, 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 a toxicology lab in Syracuse. He is currently working as one of our Research Specialists.

 

bvanhorn@email.unc.edu

Offfice Phone: (518) 926-8062

 

Clinical Pharmacology Services

Click here to download the CPAC Manifest Template to request analytical services.

Training & Tutorial Consultation
  1. Consultation for clarification, review or teaching of essential pharmacology concepts.
  2. Provision of texts and reference literature.
  3. Provision of reference material.
  4. Software tutorials (WinNonLin, Sigmaplot, Chemstation).
  5. Training in theory and use of HPLC techniques and various detection methods.
Planning & Study Design
  1. Review and critique of existing / draft protocols.
  2. Assistance in framing of hypotheses, identification of experimental factors.
  3. Collaborative development of study design.
  4. Development of pharmacokinetic/pharmacodynamic analysis plans and strategies.
  5. Justification of proposed pharmacokinetic or analytical methods and strategies, or comparison of methods.
Grant Proposal Support
  1. Budget planning for grant proposals, estimation of costs.
  2. Letters of support, biosketch, other-support pages.
  3. Writing of major sections, or collaborative editing of text.
  4. Critiques of existing grant proposals.
Pharmacokinetic/Dynamic Computation
  1. Formulation of models for data and for mechanisms which cause missing data. Routine pharmacokinetic computation for noncompartmental analyses.
  2. Custom programming for pharmacokinetic/dynamic models or simulations as necessary.
  3. Interpretive analyses of pharmacokinetic/dynamic results.
  4. Collaborative preparation of publications and presentations.

Pharmacokinetic / dynamic computation services cost recovery available upon request.

Therapeutic Drug Monitoring

The CPACC has been CLIA certified since 2002. We also participate in quarterly domestic and international proficiency testing. We have assays for the following drugs:

Coordination & Project Management
  1. Consultation on pharmacologic study implementation, operations, and monitoring adherence to protocol.
  2. Consultation regarding communication, coordination, and timelines in large studies.
Mentoring
  1. Guidance and consultation to new CFAR members.
  2. Mentoring: CFAR Developmental Awards
  3. Mentoring: NIH K23 Grant Awards
  4. Mentoring: dissertation or masters thesis students working on CFAR projects.
Referrals
  1. Identification & recruitment of appropriate professional pharmacologist or analytical chemist available to assist.
  2. Successful referral and follow-up with monitoring and verification of client satisfaction.

Analytical Services

The preclinical and clinical samples that are analyzed in our lab can be divided into 3 categories:

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

The samples the CPAC laboratory analyzes come in a variety of human and animal matrices, including, but not limited to:

• blood
• serum
• plasma
• urine
• feces
• saliva
• sputum
• peripheral blood mononuclear cells (PBMCs)
• red blood cells (RBCs)
• cervical tissue*
• rectal tissue*
• vaginal tissue*
• adipose tissue*
• rectal fluid
• cerebrospinal fluid (CSF)
• breast milk
• cervicovaginal fluid (CVF)
• semen
• dried blood spots (DBS)

Analysis costs start at $80 per sample. *Tissue analysis costs start at $100 per sample. If weights of tissues samples are not provided by the investigator, tissues can be weighed in the CPAC lab for an additional fee. QA/QC charges are calculated based on the service level (Tier 1-3) and added to the base sample analysis costs. Contact john_dohnal@unc.edu for budgeting inquiries.

Available Assays

The following is a list of drugs available to be assayed by LC-MS/MS, with their respective lower limits of quantification (LLOQ). Other assays can be developed on request.

* Drug Abbreviations listed below

 

Tier level 1

Discovery (preclinical data, preliminary data, research studies)

Note: Not all analytes at the Tier 1 level are analyzed together in the same assay

Species Matrix Analyte* Lower Limit of Quantification
Human Plasma  VOR, ROM, PAN, PRO 1 ng/mL
Human Cells (PBMCs, Isolated CD4cells) dATP, dCTP, TFVdp, FTCtp, SQV 0.02 ng/mL to 1 ng/mL
Human Cerebrospinal Fluid RAL, EFV, ATV, MVC 1 ng/mL
Human Cervicovaginal Fluid RPV 1 ng/mL
Human Cervicovaginal Lavage 3TC, RAL, FTC, TFV 1 ng/mL
Human Hair 3TC, PTCA 0.2 ng/mL – 0.5 ng/mL
Human Tissue (vaginal, rectal) TFV, FTC, RAL, MVC, EFV, ATV 0.2 ng/mL
Human Lavage RPV, DTG 1 ng/mL – 5 ng/mL
Human Media (supernatant tissue) TFV, MVC, FTC 1 ng/mL
Human Protein binding (plasma, CVF, semen) DPV 0.25 ng/mL – 0.5 ug/mL
Human RBCs dATP, dCTP 0.2 ng/mL
Human Semen 3TC, RAL, FTC, TFV, DTG, EVG 1 ng/mL
Human Rectal fluid LPV, RTV, RAL, MVC 1 ng/mL
Human Swabs TFV 6 ng/mL
Human Tissue Slices TFV, RTV, DRV, L-870812 0.05 ng/mL
Human Supernatant Ingenol-dibenzoate, VOR, ROM, PAN, PRO, Brysotatin-1 1 ng/mL to 5 ng/mL
Monkey BAL RAL, TFV, FTC 5 ng/mL
Monkey Cerebrospinal Fluid TFV, FTC, RAL, ABC 5 ng/mL
Monkey PBMC TFV, FTC, TFVdp, FTCtp, RAL 0.25 pmol/mL to 2.5 pmol/mL
Monkey Plasma TMB-607, ATV, SQV, ABC 1 ng/mL
Monkey Plasma RAL, TFV, FTC 5 ng/mL
Monkey Tissue TFV, FTC, RAL, EFV, TFVdp, FTCtp, ATV, SQV, VOR, PRO 0.02 ng/mL to 0.5 ng/mL
Monkey WBC RAL, TFV, FTC 0.25 ng/mL
Monkey Tissue RPV 1 ng/mL
Monkey Plasma GSK3563047A 0.1 ng/mL
Mouse Cells TFVdp 0.25 ng/mL
Mouse Plasma TFV, MVC, RAL, 3TC, DTG, MK-2048, RPV, ATV, DRV, d4T, SQV 1 ng/mL
Mouse Cervicovaginal Lavage TFV 1 ng/mL
Mouse Serum MK-2048 0.5 ng/mL
Mouse Lavage MK-2048 0.5 ng/mL
Mouse Tissue TFV, TFVdp, RAL, MVC, TFVdp, SQV,RPV 1 ng/mL to 6 ng/mL
Pig Tissue TFV, FTC, TFVdp, FTCtp 6 ng/mL
N/A Media, cells Nifedipine, Dehydronifedipine 50 ng/mL

  

Tier level 2

Qualified (preclinical or clinical research purposes suitable for publication,

method qualified by 1 day of Precision and Accuracy)

Species Matrix Analyte* Lower Limit of Quantification
Human Plasma DTG 1 ng/mL
Human Plasma RPV 1 ng/mL
Human Plasma EFV 1 ng/mL
Human Cervicovaginal Lavage TFV and FTC 5 ng/mL
Human Cervicovaginal Lavage RAL 5 ng/mL
Human Cervicovaginal Lavage 3TC 5 ng/mL
Human Protein Binding

EFV

ATV and RTV

0.25 ng/mL

5 ng/mL

Human Semen TFV and FTC 5 ng/mL
Human Semen RAL 5 ng/mL
Human Semen 3TC 5 ng/mL
Human Tissue TFV and FTC 6 ng/mL
Human Tissue TFVdp, FTCtp, dATP, dCTP 0.3 ng/mL
Human Cervicovaginal Fluid ATV, RTV, EVG, TFV, FTC 0.25 ng/mL – 2 ng/mL
Human Weck Cels EFV, ATV, NVP 0.2 ng/mL
Human Cervicovaginal Fluid RPV 1 ng/mL
Human Cerebrospinal Fluid APV, ATV, DRV, EVG, LPV, RTV, TFV, 3TC, FTC, ABC, ZDV 1 ng/mL
Human Cerebrospinal Fluid MVC, RAL 5 ng/mL
Human Cerebrospinal Fluid NVP 50 ng/mL
Human Tissue DTG, MVC, RPV 1 ng/mL
Human Breastmilk EFV 50 ng/mL
Human Breastmilk ETR, EVG 25 ng/mL
Human Breastmilk 3TC, TFV 1 ng/mL
Human Tissue APV, ATV, EVG, DRV, LPV, RTV, RAL 1 ng/mL
Human Plasma APX, RIV, DBG 1 ng/mL
Human Serum VOR 1 ng/mL
Human Plasma Cefazolin 0.5 µg/mL
Human Tissue Cefazolin 0.02 µg extracted/sample
Human Tissue dATP, dCTP 0.1 ng/mL
Human Hair DRV 0.05 ng/mL
Human Whole Blood DTG 10 ng/mL
Human Whole Blood MVC 3 ng/mL
Human PBMC 3TCtp 300 fmol/mL
Mouse Plasma Progesterone 0.5 ng/mL
Mouse Plasma DTV, MVC, RPV 1 ng/mL

 

Tier level 3

Validated (clinical studies for FDA submission, TDM, PT, method fully validated according to FDA guidelines)

Species Matrix Analyte* Lower Limit of Quantification
Human Breast Milk 3TC, LPV, NFV, NVP, RTV, ZDV 10 ng/mL
Human Cervicovaginal Fluid TFV and FTC 2 ng/mL
Human Hair DTG 5 pg/mL
Human Tissue TFV and TFVdp 0.02 ng/mL
Human PBMCs TFVdp, FTCtp, 0.25 pmol/mL – 2.5 pmol/mL
Human PBMCs  TFVdp, FTCtp, dATP, dCTP 0.02 ng/mL
Human Plasma TFV and FTC 0.25 ng/mL
Human Plasma MVC and RAL 5 ng/mL
Human Plasma  ZDV, 3TC, ABC, TFV, FTC, NVP 1 ng/mL
Human Plasma APV, ATV, DRV, LPV, RTV 1 ng/mL
Human Serum VOR 1 ng/mL
Human Tissue TFV, FTC, TFVdp, FTCtp 0.3 ng/mL
Human Plasma EFV 50 ng/mL
Human Plasma ETR, EVG 25 ng/mL
Human Plasma DTG, RPV, MVC 1 ng/mL
Human Plasma TMB-607 1 ng/mL
Human Dried Blood Spots TVFdp, FTCtp, 3TCtp 100 fmol/sample
Human Hair ATV, RAL 0.1 ng/mL
Human Plasma TAF 0.05 ng/mL
Human Tissue TAF 0.02 ng/mL

 

DRUG ABBREVIATIONS 

Analyte Abbreviation
Abacavir ABC
Amprenavir APV
Apixaban APX
Atazanavir ATV
Dabigatran DBG
Darunavir DRV
Dapivirine DPV
Didanosine DDI
Deoxyadenosine triphosphate dATP
Deoxycytidine triphosphate dCTP
Dolutegravir DTG
Efavirenz EFV
Elvitegravir EVG
Emtricitabine FTC
Emtricitabine Triphosphate FTCtp
Etravirine ETV
Lamivudine 3TC
Lamivudine Triphosphate 3TCtp
Lopinavir LPV
Maraviroc MVC
Nelfinavir NFV
Nevirapine NVP
Panobinostat PAN
Prostratin PRO
Raltegravir RAL
Rilpivirine RPV
Ritonavir RTV
Rivaroxaban RIV
Romidepsin ROM
Saquinavir SQV
Stavudine D4T
Tenofovir TFV
Tenofovir Alafenamide TAF
Tenofovir Diphosphate TFVdp
Vorinostat VOR
Zidovudine AZT
Analytical Methods Development

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

  1. Calibration or validation of routine antiretroviral assays in all biological matrices.
  2. Calibration or validation of routine intracellular antiretroviral assays.
  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.

Costs for method development start at $1200 for Tier 1, $4755 for Tier 2 and $20,720 for Tier 3 assay development depending on the analytes and matrices of interest and level of documentation or quality assurance requirements.

Publications

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

Widen EM, Bentley ME, Chasela CS, Kayira D, Flax VL, Kourtis AP, Ellington SR, Kacheche Z, Tegha G, Jamieson DJ, van der Horst CM, Allen LH, Shahab-Ferdows S, Adair LS; BAN Study Team. Antiretroviral Treatment Is Associated With Iron Deficiency in HIV-Infected Malawian Women That Is Mitigated With Supplementation, but Is Not Associated With Infant Iron Deficiency During 24 Weeks of Exclusive Breastfeeding. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):319-28. doi: 10.1097/QAI.0000000000000588. Erratum in: J Acquir Immune Defic Syndr. 2015 Aug 15;69(5):e184. PubMed PMID: 25723140; PubMed Central PMCID: PMC4506710.

Yang K, Lan J, Shepherd N, Hu N, Xing Y, Byrd D, Amet T, Jewell C, Gupta S, Kounga C, Gao J, Yu Q. Blockage of CD59 Function Restores Activities of Neutralizing and Nonneutralizing Antibodies in Triggering Antibody-Dependent Complement-Mediated Lysis of HIV-1 Virions and Provirus-Activated Latently Infected Cells. J Virol. 2015 Sep 15;89(18):9393-406. doi: 10.1128/JVI.01614-15. Epub 2015 Jul 1. PubMed PMID: 26136568; PubMed Central PMCID: PMC4542366.

 

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Pharmacology Training Table of Contents

Training Category Module Title Duration Video Link
Overview What is Pharmacokinectics 12:20 https://vimeo.com/220303663
Overview ART in older patients 11:02 https://vimeo.com/227701376
Overview The Pharmacology of PrEP 11:51 https://vimeo.com/227701454
Absorption Principles of Absorption 14:20 https://vimeo.com/220988942
Disposition Principles of Disposition 12:22 https://vimeo.com/220988985
Metabolism and Excretion Principles of Drug Metabolism and Excretion 12:57 https://vimeo.com/220989054
Class Specific Pharmacology Disposition of NNRTIs 15:26 https://vimeo.com/230905734
Class Specific Pharmacology Disposition of NRTIs 16:54 https://vimeo.com/230905755
Class Specific Pharmacology Disposition of PIs and boosting 14:43 https://vimeo.com/230905768
Population PK and Modeling Inter and Intra-variability in PK 11:02 https://vimeo.com/220309797
Population PK and Modeling Population Pharmacokinectics 14:01 https://vimeo.com/227701441
Population PK and Modeling PBPK Modeling 10:11 https://vimeo.com/229706801
Drug Interactions The Basics of Drug Drug Interactions 12:28 https://vimeo.com/220309881
Drug Interactions Absorption Interactions 11:56 https://vimeo.com/236571317
Drug Interactions Renal Interactions 9:20 https://vimeo.com/236571344
Drug Interactions Renal and Hepatic Interactions 7:51 https://vimeo.com/236571316
Drug Interactions Metabolic Interactions 11:04 https://vimeo.com/236571334
Drug Interactions Drug Interactions in an Aging HIV Population 11:01 https://vimeo.com/227701287

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