CraigWalterHendrixMD

HIV/AIDS Medicine

Wellcome Professor and Director, Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University School of Medicine

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Office
Harvey 502
600 N Wolfe Street
Baltimore, MD 21287
Phone+1 410-955-9707

Fax+1 410-955-9708

Summary

Dr. Craig Hendrix is a clinical pharmacologist and infectious disease specialist at Johns Hopkins University. He received his medical degree from Georgetown University School of Medicine and has been in practice 33 years. He specializes in clinical pharmacology of drug development for HIV prevention.

Education & Training

Johns Hopkins University School of MedicineFellowship, Clinical Pharmacology, 1987 - 1989
Johns Hopkins UniversityFellowship, Infectious Disease, 1986 - 1989
Johns Hopkins UniversityResidency, Internal Medicine, 1984 - 1986
Georgetown University School of MedicineClass of 1984
Massachusetts Institute of TechnologyS.B., Applied Biology, 1974 - 1978

Certifications & Licensure

MD State Medical License 1994 - 2026
PA State Medical License 1990 - 1994
American Board of Internal Medicine Internal Medicine
American Board of Internal Medicine Infectious Disease

Awards, Honors, & Recognition

William F. Abrams Award American Socity of Clinical Pharmacology & Therapeutics (ASCPT) – Food and Drug Administration (FDA) William F. Abrams Award 2019, 2019
Distinguished Investigator Award American College of Clinical Pharmacology, 2018
Award in Excellence PhRMA Foundation, 2017
David M. Levine Faculty Mentoring Award (Department of Medicine) 2007
Excellence in Teaching Award Johns Hopkins Alumni Association, 2003
Student Marshal Medical School Graduation, 2002
Outstanding Pharmacology Professor (Basic Sciences) Medical Student Association, 2001
Meritorious Service Medal, First Oak Leaf Cluster USAF, 1997
Faculty Development Award Pharmaceutical Research and Manufacturers Association, 1997
Meritorious Service Medal USAF, 1994
Department of Medicine Award for Outstanding Academic Performance Georgetown University, School of Medicine, 1984
Cahill Award for Academic Excellence in Surgery Georgetown University, School of Medicine, 1984
Magna Cum Laude Georgetown University, School of Medicine, 1984
Alpha Omega Alpha Honor Medical Society 1983
Air Force Commendation Medal USAF, 1980
Distinguished Military Graduate Massachusetts Institute of Technology, AFROTC, 1978
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Clinical Trials

Safety of AMD070 When Administered Alone or Boosted With Low-Dose Ritonavir in HIV Uninfected Men
Completed
Phase 1
Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women Start of enrollment: 2008 Jun 01
Completed
Phase 2
Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men Start of enrollment: 2007 Jul 01
Completed
Not Applicable
Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment Start of enrollment: 2009 Dec 01
Completed
Phase 1
Dose-Proportionality and Intra-Individual Variability of Intracellular TFV-DP and FTC-TP in Healthy Volunteers Start of enrollment: 2011 Jan 01
Completed
Phase 1
An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations Start of enrollment: 2013 Mar 01
Completed
Phase 1
PK/PD of Single Dose Dapivirine Vaginal Film Start of enrollment: 2013 Sep 01
Completed
Phase 1
Polymorphic Effects of Cytochrome P450 3A5 on Pharmacokinetics of Maraviroc and Its Metabolites Start of enrollment: 2013 Jan 01
Completed
Phase 1
Comparison of Tenofovir Vaginal Gel and Film Formulations Start of enrollment: 2014 Nov 01
Completed
Early Phase 1
Optimization of a Tenofovir Enema for HIV Prevention Start of enrollment: 2016 Oct 01
Completed
Phase 1
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women Start of enrollment: 2016 Mar 08
Completed
Phase 1
ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study Start of enrollment: 2017 Nov 01
Completed
Phase 1
Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults Start of enrollment: 2018 Jun 19
Completed
Phase 1
Single Dose Truvada Study Start of enrollment: 2018 Oct 25
Completed
Phase 1
Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P) Start of enrollment: 2022 Apr 01
Withdrawn
Phase 1
Tenofovir Rectal Douche to Prevent HIV Transmission Start of enrollment: 2020 Jan 10
Completed
Phase 1
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM) Start of enrollment: 2021 Apr 01
Completed
Phase 1
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Publications & Presentations

PubMed

305 citations
Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women
Raphael J. Landovitz, Deborah Donnell, Meredith E. Clement, Brett Hanscom, Leslie Cottle
The New England Journal of Medicine. 2021-08-11
15 citations
MALDI Mass Spectrometry Imaging Reveals Heterogeneous Distribution of Tenofovir and Tenofovir Diphosphate in Colorectal Tissue of Subjects Receiving a Tenofovir-Contai...
Herana Kamal Seneviratne, Craig W. Hendrix, Edward J. Fuchs, Namandjé N. Bumpus
The Journal of Pharmacology and Experimental Therapeutics. 2018-10-01
76 citations
Pre-exposure prophylaxis initiation and adherence among Black men who have sex with men (MSM) in three US cities: results from the HPTN 073 study.
Darrell P. Wheeler, Sheldon D. Fields, Geetha Beauchamp, Ying Q. Chen, Lynda Emel
Journal of the International AIDS Society. 2019-02-01

Journal Articles

Rectal Douching Practices Associated with Anal Intercourse: Implications for the Development of a Behaviorally Congruent HIV-Prevention Rectal Microbicide Douche
Craig W Hendrix, Edward J Fuchs, AIDS and Behavior
Safety, Tolerability, and Pharmacokinetics of Long-Acting Injectable Cabotegravir in Low-Risk HIV-Uninfected Individuals: HPTN 077, a Phase 2a Randomized Controlled Trial
Susan H Eshleman, Joseph J Eron, Raphael J Landovitz, Myron S Cohen, Jeremy Sugarman, Mark A Marzinke, Craig W Hendrix, PLoS One
Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women
Craig W Hendrix, Robert A Salata, Mark A Marzinke, Craig J Hoesley, Ian McGowan, Clinical Infectious Diseases
Safety and Pharmacokinetics of Single, Dual, and Triple Antiretroviral Drug Formulations Delivered by Pod-Intravaginal Rings Designed for HIV-1 Prevention: A Phase I T...
Peter A Anton, Trevelyn J Olive, Mark A Marzinke, Rochelle K Rosen, Craig W Hendrix, Kathleen L Vincent, PLoS One
HIV Antiretroviral Pre‐Exposure Prophylaxis: Development Challenges and Pipeline Promise
Craig Hendrix, MD, Clinical Pharmacology & Therapeutics
Fecal Coliform Bacterial Detection to Assess Enema Adherence in HIV Prevention Clinical Studies
Craig W Hendrix, Mark A Marzinke, Ethel Weld, Edward J Fuchs, AIDS and Behavior
Single Dose Pharmacokinetics of Oral Tenofovir in Plasma, Peripheral Blood Mononuclear Cells, Colonic and Vaginal Tissue.
Louissaint NA, Cao YJ, Skipper PL, Liberman RG, Tannenbaum SR, Nimmagadda S, Anderson JR, Everts S, Bakshi R, Fuchs EJ, Hendrix CW, AIDS Res Hum Retroviruses, 5/29/2013
Increasing Extracellular Protein Concentration Reduces Intracellular Antiretroviral Drug Concentration and Antiviral Effect.
Avery LB, Zarr M, Bakshi RP, Siliciano R, Hendrix CW, AIDS Res Hum Retroviruses, 5/22/2013
Quantitative Assessment of Altered Rectal Mucosal Permeability Due to Rectally Applied Nonoxynol-9, Biopsy, and Simulated Intercourse.
Fuchs EJ, Grohskopf LA, Lee LA, Bakshi RP, Hendrix CW, J Infect Dis, 1/13/2013
Pharmacokinetic cross-over study in women comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other anatomic compartments (MTN-001).
Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus N, PLoS One, 1/1/2013
Protein-free Efavirenz is Equivalent in Cerebrospinal Fluid & Blood Plasma: Applying the Law of Mass Action to Predict Protein-Free Drug Concentration.
Avery LB, Sacktor N, McArthur JC, Hendrix CW, Antimicrob Agents Chemother, 1/1/2013
Antiretroviral Prophylaxis for HIV Infection among People Who Inject Drugs in Bangkok, Thailand: a randomized, double-blind, placebo-controlled trial.
Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze R, Mc..., Lancet, 1/1/2013
Phase 0 Study of Intracellular Drug Concentrations: Accelerator Mass Spectrometry Measurement of Phosphorylated Tenofovir and Zidovudine.
Chen J, Flexner C, Liberman RG, Skipper PL, Louissaint NA, Tannenbaum SR, Hendrix CW, Fuchs E, J Acq Immuno Defic Syndr, 12/15/2012
Cytochrome P450 3A5 Plays a Prominent Role in the Oxidative Metabolism of the Anti-HIV Drug Maraviroc.
Lu, Y, Hendrix CW, Bumpus NN, Drug Metabol Disp, 12/1/2012
Compartmentalization and Antiviral Effect of Efavirenz Metabolites in Blood Plasma, Seminal Plasma and Cerebrospinal Fluid.
Avery LB, VanAusdall JL, Hendrix CW, Bumpus NN, Drug Metabo Disp, 11/19/2012
RMP-02/MTN-006: A Phase 1 Rectal Safety, Acceptability, Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel Compared to Oral Tenofovir DF.
AIDS Res Hum Retroviruses, 11/1/2012
Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women.
Minnis AM, Gandham S, Richardson BA, Guddera V, Riddler S, Salata R, Nakabiito C, Hoesley C, Justman J, Soto-Torres L, Patterson K, Gomez K, Hendrix CW, AIDS Behav, 10/14/2012
Antiretroviral Prophylaxis for HIV-1 Prevention among Heterosexual Men and Women.
Baeten JM, Donnell D, Ndase P, Mugo NR, et al., N Engl J Med, 8/2/2012
Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana: the TDF2 Study.
Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Segolodi TM, Soud FA, Henderson FL, Pathak SR, Rose CE, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde K, Abebe D. Buli..., N Engl J Med, 8/2/2012
Antiretroviral prophylaxis for HIV prevention in heterosexual men and women
Baeten JM1, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquh..., N Engl J Med, 8/2/2012
Stavudine (d4T) concentrations in women receiving post-partum antiretroviral treatment and their breastfeeding infants.
Fogel J, Taha TE, Sun J, Hoover DR, Parsons TL,Kumwenda JJ, Mofenson LM, Fowler MG, Hendrix CW, Kumwenda NI, Eshleman SH, Mirochnick M, JAIDS, 5/18/2012
Acyclovir achieves lower concentration in African HIV-seronegative, HSV-2 seropositive women compared to non-African populations.
Lu Y, Celum C, Wald A, Baeten JM, Cowan F, Delany-Moretlwe S, Reid SE, Hughes JP, Wilcox E, Corey L, Hendrix CW, Antimicrob Agents Chemother, 5/1/2012
Effects of ritonavir-boosted lopinavir on the pharmacokinetics of quinine.
Nyunt MM, Lu Y, Yu Q, El-Gasim M, Parsons TL, Petty BG, Hendrix CW, Clin Pharmacol Ther, 5/1/2012
Can we determine who uses? Self reports and objective measures of adherence in microbicide and PrEP trials.
Hendrix CW, 4/1/2012
Quantification of the Spatial Distribution of Rectally Applied Surrogates for Microbicide and Semen in Colon with SPECT Imaging.
Cao YJ, Caffo BS, Fuchs EJ, Lee LA, Du Y, Li L, Bakshi RP, Macura K, Khan WA, Wahl RL, Grohskopf LA, Hendrix CW, Br J Clin Pharmaco, 3/9/2012
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Books/Book Chapters

Novel Pharmacokinetic Methods for Developing HIV Chemoprevention Strategies.
Hendrix CW2005
Strategies for the Management of HIV/HCV Co-infection.
Chapter: Hepatotoxicity of antiretroviral therapy and drug-drug interactions with antiviral therapies for hepatitis C infection.
Hendrix CW, Sulkowski MSSeacaucus: Projects in Knowledge2002
Protecting Data Privacy in Health Services Research.
Chapter: Institutional Review Boards and Health Services Research Data Privacy. A Workshop Summary.
Committee on the role of institutional review boards in health services research data privacy protection.Institute of Medicine, National Academy Press, Washington, DC2000
Post-Marketing Surveillance.
Hendrix CW1999
Military AIDS Symposium.
Hendrix CW1997
AIDS: biology, diagnosis, treatment and prevention
Chapter: Pharmacology of Antiretroviral Agents.
DeVita VT, Hellman S, Rosenberg SALippincott-Raven, Philadelphia, PAEdition 4th,1997
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Lectures

Scientific Misconduct.
FDA Office of Criminal Investigations. Charleston, SC. - 6/18/2013
Making sense out of oral and topical PrEP trials: Using little studies to understand big studies.
Annual Meeting of HIV Prevention Trials Network, Washington, DC. - 5/6/2013
Pharmacological Challenges for Next Generation PrEP.
14th International Workshop on Clinical Pharmacology of HIV Therapy, Amsterdam, Netherlands. - 4/23/2013
Pharmacological Aspects of PrEP.
Hopkins-Brazil HIV conference, Rio de Janeiro, Brazil. - 4/19/2013
How PK (could) inform PrEP Trials.
NIH, Division of AIDS Seminar, Bethesda, MD. - 3/15/2013
PK Assessment of Adherence in PrEP Trials.
Pharmacometrics in Antiviral Drug Development Symposium, Annual Meeting of ASCPT, Indianapolis, IN. - 3/8/2013
Pharmacometric approaches to adherence assessment in HIV prevention trials.
Mercer University Invited talk. Atlanta, GA. - 3/5/2013
Enriching the design of clinical PK/PD studies of novel drug delivery systems.
Bill & Melinda Gates Foundation – NIH Think Tank on HIV Prevention Drug Delivery Systems. Washington - 2/1/2013
Pharmacological Approach to Monitoring Drug Adherence.
Microbicide Trials Network Annual Meeting. Bethesda, MD. - 2/1/2013
Measuring PK & Adherence in PrEP Trials: Explanation & Prediction.
RIHES, Chiang Mai University, Chiang Mai, Thailand. Department of Medicine, University of Malaya, Ku - 1/15/2013
Clinical Pharmacology Approach to Rational Rectal Microbicide Development.
Thai Red Cross/HIV-NAT, Chulalongkorn Univ, Bangkok, Thailand. - 1/10/2013
A Pharmacological Perspective on HIV Explant Challenge.
Biopsy Challenge meeting, NIH-Bill and Melinda Gates Foundation, Washington, DC. - 11/29/2012
Genital and Anal Tract PrEP Pharmacokinetics.
Office of AIDS Research Advisory Council Annual Meeting, Washington, DC. - 11/8/2012
Pharmacokinetic Assessment of PrEP Adherence.
NIH DAIDS Behavioral Science Working Group Data Capture Technologies Focus Group. - 10/11/2012
Oral & Topical PrEP: Unifying RCT Outcomes.
7th HIV Transmission Workshop, Washington, DC. - 6/1/2012
Making Sense of Oral PrEP trials: Little Studies Informing Big Studies.
Plenary Session, HPTN Annual Meeting. Washington, DC. - 6/1/2012
Antiretroviral Pharmacology for PrEP: Enhancing RCT Understanding with Small Intensive Studies.
Treatment as Prevention/Pre-Exposure Prophylaxis Summit. London, England. - 6/1/2012
Exploring Outcome Variability Across HIV Pre-Exposure Prophylaxis (PrEP) Trials.
Anti-infective Section, ASCPT Annual Meeting. National Harbor, MD. - 3/1/2012
Clinical Pharmacology in PrEP Development: Can small intensive studies inform RCTs?
Microbicide Trials Network Annual Meeting. Bethesda, MD. - 2/1/2012
Attempts to Improve the Rational Development of HIV Pre-Exposure Prophylaxis through Clinical Pharmacology.
Mercer University. School of Pharmacy. Atlanta, GA. - 2/1/2012
Clinical Pharmacology in HIV Pre-Exposure Prophylaxis Drug Development: Developing and Applying Tools when the Train has left the Station.
FDA Office of Translational Science. Silver Spring, MD. - 1/1/2012
Pharmacokinetics and Adherence in PrEP Development.
Forum for Collaborative HIV Research: 5th PrEP Working Group. San Francisco, CA. - 11/12/2011
Pharmacokinetics and Tissue Concentrations of Tenofovir and Emtricitabine: What is Needed to Prevent Transmission.
Plenary HIV Vaccine Trials Network Annual Meeting. Seattle, WA. - 11/1/2011
Pharmacological assessment of medication adherence – Oral PrEP and Microbicides.
19th International Society for STD Research. Quebec City, Canada. - 7/1/2011
Use of Pharmacokinetics for Understanding Outcomes in HIV Prevention Trials.
Lab Plenary HIV Prevention Trials Network Annual Meeting, Washington, DC. - 6/1/2011
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Other

Rectal Microbicide Development: Measuring Gel & Virus Distribution.
Hendrix CW
Web-Cast Teleconference, Invited Talk, International Rectal Microbicides Working Group. - 3/1/2006
Platelet glycoprotein IIIa PIA polymorphism and effects of aspirin on thrombin generation.
Bray PF, Goldschmidt-Clermont P, Furman MI, Michelson AD, Barnard MR, Mascelli MA, Hendrix C, Coleman L, Hamlington J, Kickler T, Christie DJ, Kundu S
Letter. Response Circulation. - 2/13/2001
AIDS in the Public Eye: AIDS Fatigue or Healthy Maturation.
Hendrix CW
Lutheran AIDS Network Newsletter - 1/1/2000
Global survey of military HIV/AIDS policies and programs.
Yeager R, Hendrix CW
Civil-Military Alliance Newsletter - 1/1/1997
Behavioral surveillance and intervention in the military environment.
Hendrix CW
Civil-Military Alliance Newsletter - 1/1/1997
Analysis of global questionnaire on HIV/AIDS prevention, testing and care in current military medical practice.
Kingma SJ, Hendrix CW, Yeager R, Miller NN, D’Amelio R, Wouters R
Occasional Paper, Civil-Military Alliance to Combat HIV and AIDS - 1/1/1996
Consideration of the prevalence of CMV retinitis alters the assessment of a serum cytomegalovirus DNA test.
Hendrix CW
Letter. J Infect Dis. - 1/1/1995
Seizing the Opportunity. HIV Prevention in Military Communities.
Hendrix CW
Civil-Military Alliance Newsletter. - 1/1/1995
Delayed-Type Hypersensitivity and AIDS.
Blatt SP, Hendrix CW
Letter. Ann Intern Med. - 1/1/1994
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Press Mentions

Cisgender Women’s Rectal Tissue May Be More Vulnerable to HIV Than Men’sJuly 15th, 2021
Johns Hopkins Names First Black Female Chair to Lead School DepartmentSeptember 6th, 2020
Namandjé Bumpus Makes History with New Department Chair RoleJune 23rd, 2020
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Grant Support

Exploratory Pharmcokinetics Of UC781 &Tenofovir Vaginal Microbicide Gel V FILMNational Institute Of Allergy And Infectious Diseases2010–2011
Phase I Rectally-Formulated Rectal MicrobicideNational Institute Of Allergy And Infectious Diseases2009
Interaction Between AMD 11070 And Sustrates Of CYP3A4 And 2D6 EnzymesNational Center For Research Resources2007
Methadone Qd With FosamprenavirNational Center For Research Resources2006–2007
A Potential Rectal Microbicide Vehicle And Semen SurrogateNational Center For Research Resources2005–2007
P5 - Effect Of Rectal Preparatory Enemas On Microbicide Distribution, TOXNational Institute Of Allergy And Infectious Diseases2006
Collection Of Biological Samples For LAB Assay DevelopmentNational Center For Research Resources2004–2006
MALE Genital TractNational Center For Research Resources2005
Sampling Frequency Limitations Of Antiretroviral DrugsNational Center For Research Resources2004–2005
Compare The Spread And Distribution Of A Potential Rectal MicrobicideNational Center For Research Resources2004–2005
Candida Ecology In The Intensive Care UnitNational Center For Research Resources2004
Antiretroviral Semen Analysis Feasibility StudyNational Center For Research Resources2004
Pharmacology Of Antiretroviral Drugs In Genital TractNational Institute Of Allergy And Infectious Diseases2000–2004
S1153 Action With Protease Inhibitors And 3tc/Zvd/D4tNational Center For Research Resources2000–2002
Pharmacokinetics Of IV AMD 3100 In Normal VolunteersNational Center For Research Resources2000–2002
P24 Antigen Levels--Antiretroviral Drug StudiesNational Center For Research Resources2000–2002
Ocular Activity Of Oral 12263w94 In AIDS CMV RetinitisNational Center For Research Resources2000–2002
Efavirenz In Combo With Ritonavir/Saquinavir In HIVNational Center For Research Resources2000–2002
Accutane/Oral Contraceptives In Women With Nodular AcneNational Center For Research Resources2000–2002
Pharmacokinetics/Safety Of Lobucavir In Subjects With Hepatic ImpairmentNational Center For Research Resources1998–2002
Pharmacokinetics And Safety Of Lobucavir In Subjects With Hepatic ImpairmentNational Center For Research Resources1998–2002
Trial To Evaluate Ocular (INTRAVITREAL) Penetration Of 1263w94National Center For Research Resources1999
Sp-303--Double-Blind, Randomized, Placebo-Controlled StudyNational Center For Research Resources1999
Safety, Pharmacokinetics, &Tolerability Of IV Administered AMD 3100National Center For Research Resources1999
Potential Interaction Between S1153 &Protease InhibitorsNational Center For Research Resources1999
Pharmacokinetic Interactions Of Ritonavir, Saquinavir &Efavirenz-Open LabelNational Center For Research Resources1999

External Links

Johns Hopkins Physicianshttp://www.hopkinsmedicine.org/craig-hendrix