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Craig W. Hendrix, MD

Craig Walter Hendrix, MD
Professor
Professor of Medicine
Male

Titles

  • Professor
  • Director, Drug Development Unit
  • Professor of Medicine
  • Professor of Pharmacology and Molecular Sciences

Centers & Institutes

  • Center for AIDS Research - Prevention Core
  • Center for Global Health

Research Interests

Chemoprevention of HIV infection; Topical HIV microbicides; Clinical pharmacology of antiviral drugs; Drug interactions

Biography

Dr. Hendrix is a Professor of Medicine and Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. He has 25 years of experience in the design and conduct of translational clinical pharmacology studies, mostly of antiretroviral drugs for HIV treatment and prevention. He serves as Director of the Drug Development Unit in the Division of Clinical Pharmacology. His research focuses on development of antiretroviral drugs to prevent HIV infection. His HIV prevention research has been supported by CDC, NIH, USAID, the Bill and Melinda Gates Foundation, amfAR, and sponsors in the pharmaceutical industry.

Dr. Hendrix received his undergraduate degree in Applied Biology at MIT (1978) and his medical degree from Georgetown University, magna cum laude (1984). He completed internship and residency in internal medicine on the Osler Medical Service, and fellowships in Infectious Diseases and Clinical Pharmacology at The Johns Hopkins Hospital. Before joining the Hopkins medical school faculty, Dr. Hendrix served on active duty for 10 years in the U.S. Air Force (USAF) where he was Director of the Air Force HIV Research and Education Program while assigned to Wilford Hall USAF Medical Center in San Antonio, TX (1989-2004), and he developed HIV prevention education programs for the United States military, United Nations Department of Peacekeeping Operations, and other militaries worldwide while assigned to the Division of Retrovirology, Walter Reed Army Institute of Research (1994-1996) and attached to the USAF Surgeon General's Office (USAF Reserve, 1997-1999). 

Currently, Dr. Hendrix serves as Director of the Drug Development Unit (DDU) which focuses on early phases of clinical drug development. The DDU is a core facility that provides support to Hopkins faculty to design, execute, and analyze clinical protocols across many therapeutic areas. DDU specializes in first in human, phase I pharmacokinetic, and phase II proof of concept studies. Dr. Hendrix's primary research focus the past decade has been chemoprevention of HIV infection which includes developing topical microbicides to prevent sexual transmission of HIV. The DDU has supported Dr. Hendrix's own research by performing key studies to understand distribution of HIV after sexual exposure, distribution of drugs within the female genital tract and colon, and the impact of microbicide vehicles on mucosal health and resistance to HIV infection.

Through the support services of the Clinical Pharmacology Analytical Laboratory (CPAL), also in the Division of Clinical Pharmacology, Dr. Hendrix has been actively involved in randomized controlled trials of drugs for pre-exposure prophylaxis (PrEP) of HIV. CPAL's work is integral to the Pharmacology Core function of the NIH-funded HIV Prevention Trials Network (HPTN) and the Microbicide Trials Network (MTN) and contributed directly to the FDA's licensure of Truvada® for prevention of HIV infection. For both the HPTN and MTN, Dr. Hendrix serves as Director of the Pharmacology Core Laboratory. 

Mentoring and teaching medical students, graduate students, and post-doctoral fellows have long been his passion and integral to the success of his own research accomplishments. Dr. Hendrix is a recipient of the Johns Hopkins Alumni Association Excellence in Teaching Award and the David M. Levine Faculty Mentoring Award at Hopkins. Seen as an opportunity to inform faculty colleagues, he has served on the Hopkins institutional review board for the past 16 years. 

Dr. Hendrix has served on the FDA Antiviral Drug Products Advisory Committee, the Board of Scientific Counselors for the National Center for Infectious Diseases, and the Board of the American Society of Clinical Pharmacology and Therapeutics.

Languages

  • English
Additional Resources +
  • Education +

    Education

    • M.D., Georgetown University, Washington, D.C.
  • Research & Publications +

    Research Summary

    Dr. Hendrix's primary research focus is chemoprevention of HIV infection. This involves 3 related areas of research: topical HIV microbicide development; pre-exposure prophylaxis of HIV; and pharmacology of anti-HIV drugs in the male genital tract. Microbicde interests include development of methods to study the distribution of microbicides and HIV in the distal colon and the female genital tract using radiology techniques and direct sampling of the sexually receptive areas. Currently, he is principal investigator of an upcoming NIH-funded, Microbicide Trials Network study (MTN-002) at 6 sites in Africa and the US comparing oral and vaginal antiretroviral strategies to prevent HIV infection. His current pre-exposure prophylaxis (PrEP) work includes acting as a principal investigator of a CDC-funded pharmacology sub-study evaluating the antiretroviral drugs, tenofovir and emtricitabine, dosed orally to prevent HIV infection in an at-risk heterosexual cohort and injection drug use cohort in Botswana and Thailand, respectively.

    Selected Publications

    Lu Y, Celum C, Wald A, Baeten JM, Cowan F, Delany-Moretlwe S, Reid SE, Hughes JP, Wilcox E, Corey L, Hendrix CW. Acyclovir achieves lower concentration in African HIV-seronegative, HSV-2 seropositive women compared to non-African populations. Antimicrob Agents Chemother 2012 May;56(5): 2777-2779. PMC 3346629

    Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Jordan W. Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A , Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix CW, Bumpus N, Bangsberg D, Haberer J, Stevens WS, Lingappa JR, Celum C. Antiretroviral Prophylaxis for HIV-1 Prevention among Heterosexual Men and Women. N Engl J Med 2012 Aug 2;367(5):399-410.

    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. Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT. Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana: the TDF2 Study. N Engl J Med 2012 Aug 2;367(5):423-34.

    Cao YJ, Caffo BS, Fuchs EJ, Lee LA, Du Y, Li L, Bakshi RP, Macura K, Khan WA, Wahl RL, Grohskopf LA, Hendrix CW. Quantification of the Spatial Distribution of Rectally Applied Surrogates for Microbicide and Semen in Colon with SPECT Imaging. Br J Clin Pharmacol 2012 2 Mar 9. doi: 10.1111/j.1365-2125.2012.04267.x. [Epub ahead of print] PMC3522815

    Chen J, Flexner C, Liberman RG, Skipper PL, Louissaint NA, Tannenbaum SR, Hendrix CW, Fuchs E. Phase 0 Study of Intracellular Drug Concentrations: Accelerator Mass Spectrometry Measurement of Phosphorylated Tenofovir and Zidovudine. J Acq Immuno Defic Syndr. 2012 Dec 15;61(5):593-9. PMC3509498

    Lu, Y, Hendrix CW, Bumpus NN. Cytochrome P450 3A5 Plays a Prominent Role in the Oxidative Metabolism of the Anti-HIV Drug Maraviroc. Drug Metabol Disp. 2012 Dec;40(12):2221-30. doi: 10.1124/dmd.112.048298. Epub 2012 Aug 24. PMC3500548

    Anton PA, Cranston RD, Kashuba A, Hendrix CW, Bumpus NN, Richardson-Harman N, Elliott J, Janocko L, Khanukhova E, Dennis R, Cumberland WG, Ju C, Carballo-Diéguez A, Mauck C, McGowan I. 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. 2012 Nov;28(11):1412-21. doi: 10.1089/AID.2012.0262. Epub 2012 Oct 9. PMC3484811

    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. Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav 2012 Oct 14. [Epub ahead of print] PMC 3562423

    Avery LB, VanAusdall JL, Hendrix CW, Bumpus NN. Compartmentalization and Antiviral Effect of Efavirenz Metabolites in Blood Plasma, Seminal Plasma and Cerebrospinal Fluid. Drug Metabo Disp 2012 Nov 19. [Epub ahead of print] PMCID: PMC 3558859

    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. Pharmacokinetic cross-over study in women comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other anatomic compartments (MTN-001) PLoS One. 2013;8(1):e55013. doi: 10.1371/journal.pone.0055013. Epub 2013 Jan 30. PMC3559346

    Fuchs EJ, Grohskopf LA, Lee LA, Bakshi RP, Hendrix CW. Quantitative Assessment of Altered Rectal Mucosal Permeability Due to Rectally Applied Nonoxynol-9, Biopsy, and Simulated Intercourse. J Infect Dis 2013 Jan 13 [Epub ahead of print]; doi: 10.1093/infdis/jit030 PMCID: PMC Journal - In Process

    Avery LB, Sacktor N, McArthur JC, Hendrix CW. Protein-free Efavirenz is Equivalent in Cerebrospinal Fluid & Blood Plasma: Applying the Law of Mass Action to Predict Protein-Free Drug Concentration. Antimicrob Agents Chemother 2013 Jan:57(3):1409-1414. Jan 7 [Epub ahead of print]. PMCID: PMC3591913

    Louissaint NA, Cao YJ, Skipper PL, Liberman RG, Tannenbaum SR, Nimmagadda S, Anderson JR, Everts S, Bakshi R, Fuchs EJ, Hendrix CW. Single Dose Pharmacokinetics of Oral Tenofovir in Plasma, Peripheral Blood Mononuclear Cells, Colonic and Vaginal Tissue. 2013 AIDS Res Hum Retroviruses. 2013 Apr 22. [Epub ahead of print] PMCID in progress

    Avery LB, Zarr M, Bakshi RP, Siliciano R, Hendrix CW. Increasing Extracellular Protein Concentration Reduces Intracellular Antiretroviral Drug Concentration and Antiviral Effect. 2013 AIDS Res Hum Retroviruses. 2013 Apr 22. [Epub ahead of print] PMCID in progress

    Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze R, McNicholl J, Paxton L, Curlin M, Hendrix CW, Vanichseni S, for the Bangkok Tenofovir Study Group. Antiretroviral Prophylaxis for HIV Infection among People Who Inject Drugs in Bangkok, Thailand: a randomized, double-blind, placebo-controlled trial. Lancet 2013.

    Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. Epub 2011 Jul 18. PMC3200068

    Dezzutti CS, Hendrix CW, Marrazzo J, Pan Z, Wang L, Louissaint N, Kalyoussef S, Torres NM, Hladik F, Parikh U, Mellors J, Hillier SL, Herold BC Comparing Swabs, Lavage, and Diluents to Quantify Biomarkers of Female Genital Tract Soluble Mucosal Mediators. 2011 PloS One 2011;6(8):e23136. PMC3155537

    Beigi R, Noguchi L, Parsons T, Macio I, Kunjara Na Ayudhya RP, Chen J, Hendrix CW, Mâsse B, Valentine M, Piper J, Watts DH. Pharmacokinetics and Placental Transfer of Single Dose Tenofovir 1% Vaginal Gel in Term Pregnancy. J Infect Dis. 2011 2011 Nov;204(10):1527-31. PMC3192189

    Louissaint NA, Nimmagadda S, Fuchs EJ, Bakshi RP, Cao Y, Lee L, Goldsmith AJ, Caffo B, Du Y, King KE, Menendez FA, Torbenson MS, Hendrix CW. Distribution of Cell-free and Cell-associated HIV surrogates in the Colon Following Simulated Receptive Anal Intercourse in Men. J Acquir Immune Defic Syndr 2012 Jan 1;59(1):10-17. PMC3237874

    Louissaint NA, Fuchs EJ, Bakshi RP, Nimmagadda S, Du Y, Macura K, King KE, Goldsmith AJ, Caffo B, Cao Y, Anderson JR, Hendrix CW. Distribution of Cell-free and Cell-associated HIV Surrogates in the Female Genital Tract following Simulated Vaginal Intercourse. J Infect Dis. 2012 Mar;205(5):725-32. NIHMS331989

    Fogel JM, Wang L, Parsons TL, Ou S-S, Piwowar-Manning E, Chen Y, Mudhune VB, Hosseinipour MC, Kumwenda J, Hakim JG, Chariyalertsak S, Panchia R, Sanne I, Kumarasamy N, Grinsztejn B, Makhema J, Pilotto J, Santos BR, Mayer KH, McCauley M, Gamble T, Bumpus NN, Hendrix CW, Cohen MS, and Eshleman SH. Undisclosed antiretroviral drug use in a multi-national clinical trial (HPTN 052). J Infect Dis. 2013.

    Leyva FJ, Bakshi R, Fuchs EJ, Li L, , Caffo BS, Goldsmith AJ, Carballo-Dieguez A, Ventuneac A Du Y, Leal J, Lee LA, Torbenson MT, Hendrix CW. Iso-osmolar enemas demonstrate preferential gastrointestinal distribution, safety, and acceptability compared with hyper- and hypo-osmolar enemas as a potential delivery vehicle for rectal microbicides. AIDS Res Hum Retroviruses 2013 (Accepted). PMCID In Progress

    Avery, L.B., Bakshi, R.P., Cao, Y.J., Hendrix, C.W. Evaluation of the male genital tract as a pharmacological sanctuary from efavirenz. Clin Pharm Ther. 90(1):151-6, 2011. 
    View on Pubmed

    Keller, M.J., Madan, R.P., Torres, N.M., Cho, S., Kalyoussef, S., Shust, G., Mesquita, P.M.M., Louissaint, N.A., Eisinger, S., Chen, J., Cohen, H.W., Carroll, E.E., Lee., A.C., Soto-Torres, L., Hendrix, C.W., Herold, B.C. Tenofovir vaginal gel study identifies candidate biomarkers predictive of microbicide efficacy and safety. PloS One 6(1):e16475, 2010. 
    View on Pubmed

    Ndovi, T.T., Choi, L., Caffo, B., Parsons, T., Baker, S., Zhao, M., Rohde, C., Hendrix, C.W.  Quantitative assessment of seminal vesicle and prostate drug concentrations by use of a non-invasive method. Clin Pharmacol Ther. 80(2):146-58, 2006. 
    View on Pubmed 

    Fuchs, E.J., Lee, L.A., Torbenson, M.S., Parsons, T.L., Bakshi, R.P., Guidos, A.M., Wahl, R.L., Hendrix, C.W. Hyperosmolar sexual lubricant causes epithelial damage in the distal colon: potential implication for HIV transmission. J Infect Dis. 195(5):703-10, 2007.
    View on Pubmed

    Hendrix, C.W., Fuchs, E.J., Macura, K.J., Lee, L.A., Parsons, T.L., Bakshi, R.P., Khan, W.A., Guidos, A., Leal, J.P., Wahl, R. Quantitative imaging and sigmoidoscopy to assess distribution of rectal microbicide surrogates. Clin Pharmacol Ther. 83(1): 97-105, 2008. 
    View on Pubmed

    Cao, Y.J., Ndovi, T.T., Parsons, T.L., Guidos, A., Caffo, B., Hendrix, C.W.   Effect of semen sampling frequency on seminal antiretroviral drug concentration. Clin Pharmacol Ther. 83(6):848-56, 2008. 
    View on Pubmed


    Cao, Y.J., Hendrix, C.W. Male Genital Tract Pharmacology: Developments in Quantitative Methods to Better Understand a Complex Peripheral Compartment. Clin Pharmacol Ther. 83(3):401-12, 2008. 
    View on Pubmed


    Cao, Y.J., Caffo, B., Choi, L., Radebaugh, C., Fuchs, E.J., Hendrix, C.W.  Noninvasive quantitation of drug concentration in prostate and seminal vesicles: improvement and validation with desipramine and aspirin. J Clin Pharmacol. 48(2):176-83, 2008.  
    View on Pubmed

    Caffo, B., Crainiceanu, C., Deng, L., Hendrix, C.W. A Case Study in Pharmacologic Imaging Using Principal Curves in Single Photon Emission Computed Tomography.  J American Statistical Assoc. 103(484):1470-80, 2008.
    View on Pubmed

    Hendrix, C.W., Cao, Y.J., Fuchs, E.J. Topical Microbicides to Prevent HIV: Clinical Drug Development Challenges. Ann Rev Pharmacol Toxicol. 49:349-75, 2009. 
    View on Pubmed

    Goldsmith, J., Caffo, B., Crainiceanu, C., Reich, D., Chen, Y., Hendrix, C.W. Non-linear Tube Fitting for the Analysis of Anatomical and Functional Structures. Ann Appl Stat. 130(484):1470-80, 2008.
    View on Pubmed

  • Academic Affiliations & Courses +
  • Activities & Honors +

    Honors

    Excellence in Teaching Award, Johns Hopkins Alumni Association

    David M. Levine Faculty Mentoring Award, Department of Medicine

    Professional Activities

    American Society for Clinical Pharmacology and Therapeutics

  • Videos & Media +
  • Upcoming Events +
  • Contact & Locations +

    Department/Division

    • Medicine - Clinical Pharmacology
    • Pharmacology and Molecular Sciences

    For Research Inquiries Contact

    Phone: 410-955-9707 Fax: 410-955-9708 600 N. Wolfe Street, Blalock 569 Baltimore, MD 21287-5554

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