Affiliation: Johns Hopkins University
- Current status and future prospects of therapeutic drug monitoring and applied clinical pharmacology in antiretroviral therapyMarta Boffito
Chelsea and Westminster Hospital, London, UK
Antivir Ther 10:375-92. 2005..In addition, the panel formulated a series of position statements that are relevant to the interpretation of current data and can aid the design of future clinical trials...
- Pharmacokinetic and metabolic effects of American ginseng (Panax quinquefolius) in healthy volunteers receiving the HIV protease inhibitor indinavirAdriana S A Andrade
Division of Infectious Diseases, The Johns Hopkins University, Baltimore, MD 21287, USA
BMC Complement Altern Med 8:50. 2008..We evaluated potential pharmacokinetic interactions between IDV and AG, and assessed whether AG improves IDV-induced insulin resistance...
- TipranavirCharles Flexner
Division of Clinical Pharmacology, Johns Hopkins University, Baltimore, Maryland 21287 5554, USA
Nat Rev Drug Discov 4:955-6. 2005
- Comparison of once-daily versus twice-daily combination antiretroviral therapy in treatment-naive patients: results of AIDS clinical trials group (ACTG) A5073, a 48-week randomized controlled trialCharles Flexner
Johns Hopkins University, Baltimore, Maryland, USA
Clin Infect Dis 50:1041-52. 2010..The primary efficacy end point was sustained virologic response (SVR; defined as reaching and maintaining an HIV RNA level <200 copies/mL) through week 48...
- HIV drug development: the next 25 yearsCharles Flexner
Johns Hopkins University, Divisions of Clinical Pharmacology and Infectious Diseases, Departments of Medicine, Pharmacology and Molecular Sciences, and International Health, Baltimore, Maryland 21287 5554, USA
Nat Rev Drug Discov 6:959-66. 2007....
- Marked intraindividual variability in antiretroviral concentrations may limit the utility of therapeutic drug monitoringRichard E Nettles
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Clin Infect Dis 42:1189-96. 2006..Effective therapeutic drug monitoring for antiretrovirals requires a better understanding of intraindividual variability in pharmacokinetics...
- Psychological distress and physical pain appear to have no short-term adverse impact on plasma HIV-1 RNA levels in patients on successful HAARTRichard E Nettles
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 08543, USA
HIV Clin Trials 6:262-71. 2005..However, the short-term effect of psychological and physical distress on HIV-1 RNA levels in patients on successful HAART has not been well studied...
- Amprenavir and lopinavir pharmacokinetics following coadministration of amprenavir or fosamprenavir with lopinavir/ritonavir, with or without efavirenzPaul A Pham
Johns Hopkins Hospital, Baltimore, MD, USA
Antivir Ther 12:963-9. 2007..Coadministration of these drugs might result in complex pharmacokinetic drug-drug interactions...
- Age-related changes in plasma concentrations of the HIV protease inhibitor lopinavirKeith W Crawford
Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, USA
AIDS Res Hum Retroviruses 26:635-43. 2010..Age-related changes in the pharmacokinetics of antiretroviral drugs may be of increasing importance as the HIV-infected population ages and as older individuals comprise an increasing proportion of new diagnoses...
- Beneficial pharmacokinetic interaction between atazanavir and lopinavir/ritonavirPaul A Pham
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
J Acquir Immune Defic Syndr 45:201-5. 2007..Because these agents, to various degrees, are substrates, inducers, and inhibitors of CYP450 3A4, there is concern for alterations in the pharmacokinetics (PK) of these combined agents...
- Possible differential induction of phase 2 enzyme and antioxidant pathways by american ginseng, Panax quinquefoliusLawrence S Lee
Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
J Clin Pharmacol 48:599-609. 2008..79; 0.72-0.86; P < .001; 8-hydroxy-deoxyguanosine ratio = 0.74; 0.59-0.92; P = .02). Two weeks of American ginseng does not alter zidovudine pharmacokinetics but reduces oxidative stress markers...
- Three distinct phases of HIV-1 RNA decay in treatment-naive patients receiving raltegravir-based antiretroviral therapy: ACTG A5248Adriana Andrade
The Johns Hopkins University, Baltimore, Maryland 21205, USA
J Infect Dis 208:884-91. 2013..The goal of this study was to define viral kinetics after initiation of raltegravir (RAL)-based antiretroviral therapy (ART)...
- Induction of chemoprotective phase 2 enzymes by ginseng and its componentsLawrence S Lee
Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
Planta Med 75:1129-33. 2009..The most potent inducing red ginseng extract also had the highest panaxytriol content, 120.8 microg/g. We found that ginseng induced NQO1 and that polyacetylenes are the most active components...
- Pharmacokinetic/pharmacodynamic modeling of the antiretroviral activity of the CCR5 antagonist Vicriviroc in treatment experienced HIV-infected subjects (ACTG protocol 5211)Keith W Crawford
Department of Clinical Pharmacology, Johns Hopkins University, Baltimore, MD 21287, USA
J Acquir Immune Defic Syndr 53:598-605. 2010..This substudy of AIDS Clinical Trials Group (ACTG) Protocol 5211 explored the relationship between antiretroviral effect and plasma concentrations of vicriviroc, an investigational CCR5 antagonist for HIV infection...
- Safety, tolerability, and pharmacokinetics of the HIV integrase inhibitor dolutegravir given twice daily with rifampin or once daily with rifabutin: results of a phase 1 study among healthy subjectsKelly E Dooley
Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA
J Acquir Immune Defic Syndr 62:21-7. 2013..This study evaluated the effect of RIF or rifabutin (RBT) on the pharmacokinetics of the investigational HIV integrase inhibitor, dolutegravir (DTG)...
- Safety, tolerability, and pharmacokinetic interactions of the antituberculous agent TMC207 (bedaquiline) with efavirenz in healthy volunteers: AIDS Clinical Trials Group Study A5267Kelly E Dooley
Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA
J Acquir Immune Defic Syndr 59:455-62. 2012..Bedaquiline (formerly TMC207), an investigational agent for the treatment of tuberculosis, is metabolized by cytochrome P450 (CYP) 3A which may be induced by the antiretroviral drug efavirenz...
- Biphasic elimination of tenofovir diphosphate and nonlinear pharmacokinetics of zidovudine triphosphate in a microdosing studyJianmeng Chen
Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA
J Acquir Immune Defic Syndr 61:593-9. 2012..To evaluate the prediction of microdosing for active intracellular drug metabolites, we compared the PK profile of 2 antiretroviral drugs, zidovudine (ZDV) and tenofovir (TFV), in microdose and standard dosing regimens...
- Intermittent HIV-1 viremia (Blips) and drug resistance in patients receiving HAARTRichard E Nettles
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
JAMA 293:817-29. 2005....
- Repeated administration of high-dose intermittent rifapentine reduces rifapentine and moxifloxacin plasma concentrationsKelly Dooley
Divisions of Infectious Diseases, Johns Hopkins University, Baltimore, Maryland 21231, USA
Antimicrob Agents Chemother 52:4037-42. 2008..Changes consistent with rifapentine autoinduction of metabolism were seen. Adverse reactions in two subjects may have represented rifamycin hypersensitivity syndrome, although some features were atypical...
- Drug interactions involving combination antiretroviral therapy and other anti-infective agents: repercussions for resource-limited countriesKelly E Dooley
Department of Medicine, Johns Hopkins University, Baltimore, Maryland 21205, USA
J Infect Dis 198:948-61. 2008
- Steady-state pharmacokinetic interaction of modified-dose indinavir and rifabutinFayez M Hamzeh
Johns Hopkins Hospital, Johns Hopkins University, Osler 527, 600 N Wolfe Street, Baltimore, MD 21287 5554, USA
Clin Pharmacol Ther 73:159-69. 2003..Therefore this study was designed to evaluate alternative dosing regimens...
- Multiple-dose escalation study of the safety, pharmacokinetics, and biologic activity of oral AMD070, a selective CXCR4 receptor inhibitor, in human subjectsNimalie D Stone
Johns Hopkins University School of Medicine, Division of Clinical Pharmacology, Harvey 502, 600 N Wolfe Street, Baltimore, MD 21287, USA
Antimicrob Agents Chemother 51:2351-8. 2007..Trough concentrations with the 400-mg dose q12h exceeded the antiviral in vitro 90% effective concentration of AMD070...
- Emerging antiretroviral drug interactionsPaul A Pham
Division of Infectious Diseases, Johns Hopkins University, School of Medicine, Baltimore, MD 21287, USA
J Antimicrob Chemother 66:235-9. 2011..g. darunavir, raltegravir, maraviroc and etravirine)...
- Use of antineoplastic agents in patients with cancer who have HIV/AIDSMichelle A Rudek
Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA
Lancet Oncol 12:905-12. 2011..We will review potential pharmacological interactions between antiretroviral and antineoplastic therapies and consider how to combine antiretroviral and antineoplastic agents in patients with HIV who are receiving HAART therapy...
- Effect of hydroxyurea and dideoxyinosine on intracellular 3'-deoxyadenosine-5'-triphosphate concentrations in HIV-infected patientsRahul P Bakshi
Division of Clinical Pharmacology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland 21287, USA
AIDS Res Hum Retroviruses 23:1360-5. 2007..Since a significant reduction in dATP was measurable only when ddI was combined with HU, the antiretroviral activity of ddI may be more complex than previously assumed...
- Optimising the manufacture, formulation, and dose of antiretroviral drugs for more cost-efficient delivery in resource-limited settings: a consensus statementKeith W Crawford
Johns Hopkins University, School of Medicine, Division of Clinical Pharmacology, Baltimore, MD, USA
Lancet Infect Dis 12:550-60. 2012..Optimising pharmacoenhancement and extending shelf life are additional strategies. The conference highlighted a range of interventions; optimum cost savings could be achieved through combining approaches...
- Interactions between natural health products and antiretroviral drugs: pharmacokinetic and pharmacodynamic effectsLawrence S Lee
Division of Clinical Pharmacology, Johns Hopkins University, Baltimore, MD, USA
Clin Infect Dis 43:1052-9. 2006..Before recommending the use of NHPs as adjuncts to ARV use, studies should first exclude significant pharmacokinetic interactions and ensure that ARV efficacy is maintained...
- Optimization and simplification of antiretroviral therapy for adults and childrenNathan Ford
aHIV AIDS Department, World Health Organization, Geneva, Switzerland bDepartments of Medicine, Pharmacology, and International Health, Johns Hopkins University, Baltimore, Maryland, USA cDepartment of Pharmacological Research and Medicines Evaluation, Istituto Superiore di Sanita, Rome, Italy dClinton Health Access Initiative, Boston, USA
Curr Opin HIV AIDS 8:591-9. 2013..The review reflects on opportunities and challenges for HIV treatment optimization for the next 5 years...
- Treatment optimization: an outline for future successCharles Flexner
aJohns Hopkins University School of Medicine and Bloomberg School of Public Health, Baltimore, Maryland bPangaea Global AIDS Foundation, Oakland, California cClinton Health Access Initiative, Boston, Massachusetts, USA
Curr Opin HIV AIDS 8:523-7. 2013..In this introduction, we outline current goals and approaches that will be described in more detail elsewhere in this issue...
- The antiretroviral drug pipeline: prospects and implications for future treatment researchCharles Flexner
aJohns Hopkins University School of Medicine and Bloomberg School of Public Health, Baltimore, Maryland bUniversity of Alabama at Birmingham, Birmingham, Alabama, USA
Curr Opin HIV AIDS 8:572-8. 2013..A number of investigational antiretroviral drugs in clinical development could alter the future treatment landscape for resource-limited settings and contribute to optimized therapy for HIV infection...
- Differential effects of p-glycoprotein and multidrug resistance protein-1 on productive human immunodeficiency virus infectionR Renae Speck
Department of Clinical Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
J Infect Dis 186:332-40. 2002..These results suggest that the inhibition of HIV productive infection by P-gp and augmentation by MRP-1 occur predominantly at a preintegration step but act through different mechanisms...
- In vivo emergence of vicriviroc resistance in a human immunodeficiency virus type 1 subtype C-infected subjectAthe M N Tsibris
Massachusetts General Hospital, Boston, Massachusetts, USA
J Virol 82:8210-4. 2008..Pretreatment V3 loop sequences reemerged following VCV discontinuation, implying that VCV resistance has associated fitness costs...
- Pharmacology and drug interactions: a progress reportAdriana Andrade
Hopkins HIV Rep 14:8-9. 2002
- Effect of simultaneous versus staggered dosing on pharmacokinetic interactions of protease inhibitorsCarla B Washington
Department of Medicine, Stanford University Medical Center, Stanford, CA 94305 5130, USA
Clin Pharmacol Ther 73:406-16. 2003..The aim of this study was to determine whether pharmacokinetic interactions between the protease inhibitors saquinavir soft gel, nelfinavir, and ritonavir are affected by the timing of administration...
- Progress in pharmacology and drug interactions from the 10th CROIAdriana Andrade
Hopkins HIV Rep 15:7, 11. 2003
- Update from the 6th International Workshop on the Clinical Pharmacology of HIV Therapy: new drugs, new formulations and drug interactionsCharles Flexner
Hopkins HIV Rep 17:1-3, 10-1. 2005
- Activity, safety, and immunological effects of hydroxyurea added to didanosine in antiretroviral-naive and experienced HIV type 1-infected subjects: a randomized, placebo-controlled trial, ACTG 307Ian Frank
AIDS Res Hum Retroviruses 20:916-26. 2004..HU may continue to have a role as a component of HIV therapy...
- Simplifying antiretroviral therapyMichael L Tapper
New York University School of Medicine, New York, USA
AIDS Read 14:355-60, 367-71. 2004..Additional studies should add to this experience and provide guidance on the role and timing of such regimens in the management of patients with HIV disease...
- Genes, ethnicity, and efavirenz response: clinical pharmacology update from the 11th CROIAdriana Andrade
Hopkins HIV Rep 16:1-7. 2004
- Drug development strategies for salvage therapy: conflicts and solutionsVictor De Gruttola
Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, USA
AIDS Res Hum Retroviruses 22:1106-9. 2006
- Phase 2 study of the safety and efficacy of vicriviroc, a CCR5 inhibitor, in HIV-1-Infected, treatment-experienced patients: AIDS clinical trials group 5211Roy M Gulick
Weill Medical College of Cornell University, New York, New York, NY, USA
J Infect Dis 196:304-12. 2007..Vicriviroc, an investigational CCR5 inhibitor, demonstrated short-term antiretroviral activity in a phase 1 study...
- High-dose lopinavir/ritonavir in highly treatment-experienced HIV-1 patients: efficacy, safety, and predictors of responseDaniel Podzamczer
Infectious Disease Service, Hospital Universitari de Bellvitge, Barcelona, Spain
HIV Clin Trials 8:193-204. 2007..To investigate the efficacy and safety of high-dose lopinavir/ritonavir (LPV/r) therapy in multiple protease inhibitor, non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced subjects...
- Therapeutic drug monitoring and drug-drug interactions involving antiretroviral drugsMarta Boffito
Chelsea and Westminster Hospital, London, UK
Antivir Ther 10:469-77. 2005....
- Model-based analysis of the pharmacokinetic interactions between ritonavir, nelfinavir, and saquinavir after simultaneous and staggered oral administrationJian feng Lu
Department of Biopharmaceutical Sciences, University of California San Francisco, San Francisco, California 94143 0626, USA
Drug Metab Dispos 30:1455-61. 2002....
- Pharmacology at the 12th CROI: generic antiretrovirals, drug interactions, and therapeutic drug monitoringAdriana Andrade
Hopkins HIV Rep 17:6-9. 2005
- Selected topics from the 9th Conference on Retroviruses and Opportunistic InfectionsRichard E Chaisson
HIV Clin Trials 3:333-49. 2002
- HLA B57 and abacavir hypersensitivityCharles Flexner
Hopkins HIV Rep 14:5. 2002
- IQs, VIQs, and NIQs: are we smart yet?Charles Flexner
Hopkins HIV Rep 14:6-7. 2002
- More from CROI...new drugs: full pipeline, steady progressCharles Flexner
Hopkins HIV Rep 15:4-5. 2003
- A prospective, randomized trial examining the efficacy and safety of clarithromycin in combination with ethambutol, rifabutin, or both for the treatment of disseminated Mycobacterium avium complex disease in persons with acquired immunodeficiency syndromeConstance A Benson
Division of Infectious Diseases, University of Colorado Health Sciences Center, Denver, USA
Clin Infect Dis 37:1234-43. 2003..057). Subjects in the C+E+R group had improved survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.23-0.83) and the C+R group (HR, 0.49; 95% CI, 0.26-0.92)...
- Diarrhea-associated HIV-1 APIs potentiate muscarinic activation of Cl- secretion by T84 cells via prolongation of cytosolic Ca2+ signalingPaul A Rufo
GI Cell Biology, Combined Program in Pediatric Gastroenterology and Nutrition, Children s Hospital, 300 Longwood Ave, Boston, MA 02115, USA
Am J Physiol Cell Physiol 286:C998-C1008. 2004..These data show that APIs modulate Ca(2+) signaling in secretory epithelial cells and identify a novel target for treatment of clinically important API side effects...
- Report from Boston: the 12th Conference on Retroviruses and Opportunistic Infections (CROI). New drugs, new targets: good news on the horizonCharles Flexner
Hopkins HIV Rep 17:8-9. 2005
- HIV type 1 chemokine coreceptor use among antiretroviral-experienced patients screened for a clinical trial of a CCR5 inhibitor: AIDS Clinical Trial Group A5211Timothy J Wilkin
Division of International Medicine and Infectious Diseases, Weill Cornell Medical College, New York, NY, USA
Clin Infect Dis 44:591-5. 2007..Chemokine coreceptor use impacts both the natural history of human immunodeficiency virus type 1 (HIV-1) disease and the potential use of a new class of antiretroviral agents, the CCR5 inhibitors...
- New drugs: attacking chemokine receptorsCharles Flexner
Hopkins HIV Rep 14:12. 2002
- Johns Hopkins AIDS Clinical Trials UnitCharles Flexner; Fiscal Year: 2008..This CTU is well-positioned to continue its broad and substantial contributions to national and international HIV clinical research, while also serving its community. ADMINISTRATIVE COMPONENT: ..
- Johns Hopkins AIDS Clinical Trials UnitCharles Flexner; Fiscal Year: 2008..This CTU is well-positioned to continue its broad and substantial contributions to national and international HIV clinical research, while also serving its community. ..