Margaret A Fischl
Affiliation: University of Miami
- Randomized open-label trial of two simplified, class-sparing regimens following a first suppressive three or four-drug regimenMargaret A Fischl
AIDS Clinical Research Unit R 60A, Department of Medicine, University of Miami School of Medicine, 1800 NW 10th Avenue, Miami, FL 33136, USA
AIDS 21:325-33. 2007..Complex antiretroviral regimens can be associated with increased toxicity and poor adherence. Our aim was to compare the efficacy and safety of switching to two simplified, class-sparing antiretroviral regimens...
- A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus diseaseMargaret A Fischl
Department of Medicine, University of Miami School of Medicine, Miami, Florida 33101, USA
J Infect Dis 188:625-34. 2003..A 4-drug regimen containing efavirenz plus indinavir resulted in a superior virologic response, whereas one containing nelfinavir plus indinavir resulted in an inferior response and a greater likelihood of toxicity...
- Abacavir/lamivudine versus tenofovir DF/emtricitabine as part of combination regimens for initial treatment of HIV: final resultsPaul E Sax
Division of Infectious Diseases, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA
J Infect Dis 204:1191-201. 2011..Due to higher virologic failure with ABC/3TC in the high HIV RNA stratum, blinded treatment was stopped in this group, but study follow-up continued for all patients...
- Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panelScott M Hammer
Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York 10032, USA
JAMA 296:827-43. 2006..The International AIDS Society-USA panel has updated its recommendations as warranted by new developments in the field...
- Twice-daily Trizivir versus Combivir-abacavir in antiretroviral-experienced adults with human immunodeficiency virus-1 infection: a formulation-switch trialMargaret A Fischl
University of Miami, School of Medicine, Department of Medicine, Florida 33136, USA
Pharmacotherapy 23:1432-40. 2003....
- Immune exhaustion occurs concomitantly with immune activation and decrease in regulatory T cells in viremic chronically HIV-1-infected patientsMeenakshi Sachdeva
Department of Microbiology and Immunology, Developmental Center for AIDS Research, University of Miami Miller School of Medicine, Miami, FL 33136, USA
J Acquir Immune Defic Syndr 54:447-54. 2010..We investigated the relationship of these 2 phenotypes and frequency of regulatory T cells (Tregs) in controlled and uncontrolled chronic HIV-1 infection...
- Preclinical evaluation of HIV-1 therapeutic ex vivo dendritic cell vaccines expressing consensus Gag antigens and conserved Gag epitopesLiguo Niu
Department of Microbiology and Immunology, Miller School of Medicine, University of Miami, 1580 NW 10th Ave, Miami, FL, USA
Vaccine 29:2110-9. 2011..In addition, little is known regarding whether specific HIV-1 proteome components, such as highly conserved regions of the HIV-1, could enhance clinical responses following DC therapy...
- Factors associated with altered pharmacokinetics in substance users and non-substance users receiving lopinavir and atazanavirNiamh Higgins
Pharmacotherapy Research Center, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Amherst, New York 14260, USA
Am J Addict 16:488-94. 2007..These data indicate that chronic HIV treatment may be assisted with plasma concentration monitoring to identify those patients who may require dosage modification and/or regimen adjustment in order to optimize antiretroviral effects...
- Integration of atazanavir into an existing liquid chromatography UV method for protease inhibitors: validation and applicationKim Keil
Pharmacotherapy Research Center, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, New York 14260, USA
Ther Drug Monit 29:103-9. 2007..During 2 years, more than 100 batches of analyses have been performed and have proved the method is rugged, specific, and accurate. This assay method is currently used in the authors' clinical research program in TDM...
- Multidrug resistance 1 polymorphisms and trough concentrations of atazanavir and lopinavir in patients with HIVQing Ma
University at Buffalo, Pharmacotherapy Research Center, School of Pharmacy and Pharmaceutical Sciences, NY, USA
Pharmacogenomics 8:227-35. 2007..We examined MDR1 single nucleotide polymorphisms in a cohort of patients in whom therapeutic drug monitoring is ongoing through a research protocol...
- Buprenorphine assay and plasma concentration monitoring in HIV-infected substance usersRobin DiFrancesco
Pharmacotherapy Research Center, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY, USA
J Pharm Biomed Anal 44:188-95. 2007..Use of this combined BUP and ARV plasma concentration monitoring approach for a representative patient receiving BUP, atazanavir and efavirenz demonstrated its clinical application...
- Switching to a protease inhibitor-containing, nucleoside-sparing regimen (lopinavir/ritonavir plus efavirenz) increases limb fat but raises serum lipid levels: results of a prospective randomized trial (AIDS clinical trial group 5125s)Pablo Tebas
Division of Infectious Diseases, University of Pennsylvania, Philadelphia, PA 19104, USA
J Acquir Immune Defic Syndr 45:193-200. 2007..Subcutaneous limb fat loss continues to be one the most troubling side effects of long-term antiretroviral regimens. Nucleoside analogues and protease inhibitors (PIs) have been linked to the development of this complication...
- Assessing the impact of substance use and hepatitis coinfection on atazanavir and lopinavir trough concentrations in HIV-infected patients during therapeutic drug monitoringJudianne Slish
Pharmacotherapy Research Center, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Amherst, New York 14260, USA
Ther Drug Monit 29:560-5. 2007..Further work is needed to assess the optimal dosing regimen when using LPV in HIV-infected substance users...
- Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA panelScott M Hammer
Division of Infectious Diseases, Columbia University College of Physicians and Surgeons, 630 W 168th St, New York, NY 10032, USA
JAMA 300:555-70. 2008....
- Intracellular nucleoside triphosphate concentrations in HIV-infected patients on dual nucleoside reverse transcriptase inhibitor therapyJeff D Moore
University of Alabama at Birmingham, Division of Clinical Pharmacology, Birmingham, AL, USA
Antivir Ther 12:981-6. 2007..Little is known about how commonly used dual-NRTI regimens affect the intracellular levels of NRTI-TPs, the active form of these drugs. This study investigates the effect of dual-NRTI therapy in intracellular NRTI-TP levels...
- Randomized study of dual versus single ritonavir-enhanced protease inhibitors for protease inhibitor-experienced patients with HIVAnn C Collier
University of Washington School of Medicine and Harborview Medical Center, Seattle, Washington 98104, USA
HIV Clin Trials 9:91-102. 2008....
- Interferon-alpha2b with protease inhibitor-based antiretroviral therapy in patients with AIDS-associated Kaposi sarcoma: an AIDS malignancy consortium phase I trialSusan E Krown
Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA
J Acquir Immune Defic Syndr 41:149-53. 2006..This study establishes a safe dose of IFN that can be used with HAART and, potentially, with other inhibitors of KS in future clinical trials...
- A randomized study of serial telephone call support to increase adherence and thereby improve virologic outcome in persons initiating antiretroviral therapyAnn C Collier
University of Washington School of Medicine and Harborview Medical Center, Seattle, WA 98104, USA
J Infect Dis 192:1398-406. 2005..Adherence to antiretroviral therapy is difficult, and methods to increase it are needed...
- Mutations in HIV-1 reverse transcriptase during therapy with abacavir, lamivudine and zidovudine in HIV-1-infected adults with no prior antiretroviral therapyMounir Ait-Khaled
GlaxoSmithKline Research and Development, Stevenage, UK
Antivir Ther 7:43-51. 2002..To evaluate HIV-1 reverse transcriptase (RT) drug resistance in patients receiving abacavir, lamivudine and zidovudine therapy...
- Detection of replication-competent human immunodeficiency virus type 1 (HIV-1) in cultures from patients with levels of HIV-1 RNA in plasma suppressed to less than 500 or 50 copies per milliliterLisa M Demeter
University of Rochester School of Medicine and Dentistry, Rochester, New York 14642, USA
J Clin Microbiol 40:2089-94. 2002..The delay in the time required for HIV cultures to turn positive should be considered when attempting to obtain an HIV isolate from patients with suppression of plasma viral load...
- Antiretroviral treatment for adult HIV infection in 2002: updated recommendations of the International AIDS Society-USA PanelPatrick G Yeni
Hopital Bichat Claude Bernard, Department of Infectious Diseases, 46 rue Henri Huchard, Paris, Cedex 18 France 75877
JAMA 288:222-35. 2002..These updated recommendations are intended to guide practicing physicians actively involved in human immunodeficiency virus (HIV)- and acquired immunodeficiency syndrome (AIDS)-related care...
- Open-label study of a twice-daily indinavir 800-mg/ritonavir 100-mg regimen in protease inhibitor-naive HIV-infected adultsBenjamin Young
Rose Medical Center, Denver, CO, USA
J Acquir Immune Defic Syndr 31:478-82. 2002..In this study, twice-daily indinavir 800 mg/ritonavir 100 mg with two nucleoside reverse transcriptase inhibitors provided potent viral suppression and immunologic reconstitution in many PI-naive patients...
- Indinavir, efavirenz, and abacavir pharmacokinetics in human immunodeficiency virus-infected subjectsRobert Dicenzo
University at Buffalo, Buffalo, New York, USA
Antimicrob Agents Chemother 47:1929-35. 2003..Abacavir did not influence the pharmacokinetics or exposure parameters of either indinavir or efavirenz. The levels of efavirenz exposure were similar in subjects receiving efavirenz q12h or q24h...
- Long-term efficacy, safety, and tolerability of indinavir-based therapy in protease inhibitor-naive adults with advanced HIV infectionMartin S Hirsch
Massachusetts General Hospital, Harvard Medical School, Boston, USA
Clin Infect Dis 37:1119-24. 2003..Hyperbilirubinemia (experienced by 31% of subjects), nausea (17%), abdominal pain (14%), and nephrolithiasis (13%) were the most common drug-related adverse events during the extension...
- Comparison of sequential three-drug regimens as initial therapy for HIV-1 infectionGregory K Robbins
Harvard Medical School, Boston, USA
N Engl J Med 349:2293-303. 2003..The optimal sequencing of antiretroviral regimens for the treatment of infection with human immunodeficiency virus type 1 (HIV-1) is unknown. We compared several different antiretroviral treatment strategies...
- Association of T cell proliferative responses and phenotype with virus control in chronic progressive HIV-1 diseaseUma Malhotra
Program in Infectious Diseases, Clinical Research Division, Fred Hutchinson Cancer Research Center, and Department of Medicine, University of Washington School of Medicine, Seattle, Washington 98109, USA
J Infect Dis 189:515-9. 2004..These findings indicate that Fas coexpression on T cells, in addition to plasma HIV-1 RNA levels and CD4+ T cell counts, may predict virologic outcome...
- A randomized trial of nelfinavir and abacavir in combination with efavirenz and adefovir dipivoxil in HIV-1-infected persons with virological failure receiving indinavirScott M Hammer
Columbia University, New York, NY, USA
Antivir Ther 8:507-18. 2003
- Pharmacokinetics of indinavir and nelfinavir in treatment-naive, human immunodeficiency virus-infected subjectsRobert Dicenzo
University at Buffalo, Buffalo, New York 14260, USA
Antimicrob Agents Chemother 48:918-23. 2004..5 to 5,540 ng/ml). Due to the unacceptable number of undetectable indinavir trough concentrations, 1200 mg of indinavir appears to be the preferred dose in a twice-daily regimen that includes nelfinavir...
- Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA PanelPatrick G Yeni
Department of Infectious Diseases, Hopital Bichat Claude Bernard, X Bichat Medical School, Paris, France
JAMA 292:251-65. 2004..Substantial changes in the field of human immunodeficiency virus (HIV) treatment have occurred in the last 2 years, prompting revision of the guidelines for antiretroviral management of adults with established HIV infection...
- HIV-1 drug resistance in subjects with advanced HIV-1 infection in whom antiretroviral combination therapy is failing: a substudy of AIDS Clinical Trials Group Protocol 388Lisa M Demeter
Infectious Diseases Unit, University of Rochester, Rochester, New York 14642, USA
Clin Infect Dis 39:552-8. 2004..Thus, although dual resistance to efavirenz and lamivudine occurred at VF in the efavirenz-indinavir arm, this risk was relatively low when evaluated in the context of the potency and tolerability of this regimen...
- Pharmacokinetics of nelfinavir and efavirenz in antiretroviral-naive, human immunodeficiency virus-infected subjects when administered alone or in combination with nucleoside analog reverse transcriptase inhibitorsPatrick F Smith
Adult ACTG Pharmacology Support Laboratory, Laboratory for Antiviral Research, Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, NY 12460, USA
Antimicrob Agents Chemother 49:3558-61. 2005..There were no significant differences in efavirenz pharmacokinetics...
- Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatmentLarry R Kirkland
Burnside Clinic, Columbia, SC, USA
Clin Infect Dis 34:511-8. 2002..The overall adherence to prescribed doses was 94% for patients who remained enrolled in the study. COM-abacavir given twice daily was generally well tolerated, and adverse events prompted only 4 patients to withdraw from the study...
- Miami HIV/AIDS Clinical Therapeutic and Vaccine Trial UnitMargaret Fischl; Fiscal Year: 2007..The proposed clinical trials and investigations will advance our understanding of the treatment and pathogenesis of HIV/AIDS, and lead to improved care and prevention of HIV. ADMINISTRATIVE COMPONENT: ..