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  1. Article ; Online: Translational Models to Predict Target Concentrations for Pre-Exposure Prophylaxis in Women.

    Lantz, Alyssa M / Nicol, Melanie R

    AIDS research and human retroviruses

    2022  Volume 38, Issue 12, Page(s) 909–923

    Abstract: The HIV epidemic remains a significant public health burden. Women represent half of the global HIV epidemic, yet there is an urgent need for a variety of prevention options to meet the needs of more women. Pre-exposure prophylaxis (PrEP) is a valuable ... ...

    Abstract The HIV epidemic remains a significant public health burden. Women represent half of the global HIV epidemic, yet there is an urgent need for a variety of prevention options to meet the needs of more women. Pre-exposure prophylaxis (PrEP) is a valuable prevention tool that uses antiretrovirals before a potential HIV exposure to prevent virus transmission. Development of effective preventive drug regimens for women is dependent on convenient dosing schedules and routes of administration, and on identifying defined target concentrations in mucosal tissues that provide complete protection against HIV transmission. There is a critical need for a translational model that can accurately predict
    MeSH term(s) Female ; Mice ; Animals ; Pre-Exposure Prophylaxis ; HIV Infections ; Anti-HIV Agents/therapeutic use ; Anti-Retroviral Agents/therapeutic use ; Genitalia, Female
    Chemical Substances Anti-HIV Agents ; Anti-Retroviral Agents
    Language English
    Publishing date 2022-10-25
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, N.I.H., Extramural
    ZDB-ID 639130-8
    ISSN 1931-8405 ; 0889-2229
    ISSN (online) 1931-8405
    ISSN 0889-2229
    DOI 10.1089/AID.2022.0057
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Reply to Neves.

    Nicol, Melanie R / Boulware, David R / Rajasingham, Radha

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2020  Volume 73, Issue 7, Page(s) e1772–e1774

    Language English
    Publishing date 2020-11-30
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciaa1809
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    Zs.MO 480: Show issues

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  3. Article ; Online: Treating viruses in the brain: Perspectives from NeuroAIDS.

    Nicol, Melanie R / McRae, MaryPeace

    Neuroscience letters

    2021  Volume 748, Page(s) 135691

    Abstract: Aggressive use of antiretroviral therapy has led to excellent viral suppression within the systemic circulation. However, despite these advances, HIV reservoirs still persist. The persistence of HIV within the brain can lead to the development of HIV- ... ...

    Abstract Aggressive use of antiretroviral therapy has led to excellent viral suppression within the systemic circulation. However, despite these advances, HIV reservoirs still persist. The persistence of HIV within the brain can lead to the development of HIV-associated neurocognitive disorders (HAND). Although the causes of the development of neurocognitive disorders is likely multifactorial, the inability of antiretroviral therapy to achieve adequate concentrations within the brain is likely a major contributing factor. Information about antiretroviral drug exposure within the brain is limited. Clinically, drug concentrations within the cerebrospinal fluid (CSF) are used as markers for central nervous system (CNS) drug exposure. However, significant differences exist; CSF concentration is often a poor predictor of drug exposure within the brain. This article reviews the current information regarding antiretroviral exposure within the brain in humans as well as preclinical animals and discusses the impact of co-morbidities on antiretroviral efficacy within the brain. A more thorough understanding of antiretroviral penetration into the brain is an essential component to the development of better therapeutic strategies for neuroAIDS.
    MeSH term(s) Animals ; Anti-Retroviral Agents/pharmacology ; Brain/drug effects ; Central Nervous System/drug effects ; Drug Delivery Systems ; HIV Infections/drug therapy ; HIV Infections/virology ; HIV-1/drug effects ; Humans
    Chemical Substances Anti-Retroviral Agents
    Language English
    Publishing date 2021-01-30
    Publishing country Ireland
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 194929-9
    ISSN 1872-7972 ; 0304-3940
    ISSN (online) 1872-7972
    ISSN 0304-3940
    DOI 10.1016/j.neulet.2021.135691
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  4. Article ; Online: The Musashi RNA binding proteins direct the translational activation of key pituitary mRNAs.

    Banik, Jewel / Moreira, Ana Rita Silva / Lim, Juchan / Tomlinson, Sophia / Hardy, Linda L / Lagasse, Alex / Haney, Anessa / Crimmins, Meghan R / Boehm, Ulrich / Odle, Angela K / MacNicol, Melanie C / Childs, Gwen V / MacNicol, Angus M

    Scientific reports

    2024  Volume 14, Issue 1, Page(s) 5918

    Abstract: The pituitary functions as a master endocrine gland that secretes hormones critical for regulation of a wide variety of physiological processes including reproduction, growth, metabolism and stress responses. The distinct hormone-producing cell lineages ... ...

    Abstract The pituitary functions as a master endocrine gland that secretes hormones critical for regulation of a wide variety of physiological processes including reproduction, growth, metabolism and stress responses. The distinct hormone-producing cell lineages within the pituitary display remarkable levels of cell plasticity that allow remodeling of the relative proportions of each hormone-producing cell population to meet organismal demands. The molecular mechanisms governing pituitary cell plasticity have not been fully elucidated. Our recent studies have implicated a role for the Musashi family of sequence-specific mRNA binding proteins in the control of pituitary hormone production, pituitary responses to hypothalamic stimulation and modulation of pituitary transcription factor expression in response to leptin signaling. To date, these actions of Musashi in the pituitary appear to be mediated through translational repression of the target mRNAs. Here, we report Musashi1 directs the translational activation, rather than repression, of the Prop1, Gata2 and Nr5a1 mRNAs which encode key pituitary lineage specification factors. We observe that Musashi1 further directs the translational activation of the mRNA encoding the glycolipid Neuronatin (Nnat) as determined both in mRNA reporter assays as well as in vivo. Our findings suggest a complex bifunctional role for Musashi1 in the control of pituitary cell function.
    MeSH term(s) RNA, Messenger/genetics ; RNA, Messenger/metabolism ; RNA-Binding Proteins/metabolism ; Pituitary Gland/metabolism ; Protein Processing, Post-Translational ; Pituitary Hormones/metabolism
    Chemical Substances RNA, Messenger ; RNA-Binding Proteins ; Pituitary Hormones
    Language English
    Publishing date 2024-03-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-024-56002-8
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  5. Article ; Online: The Complex Roadmap to Infectious Disease Innovation: The Intersection of Bugs, Drugs, and Special Populations.

    Nicol, Melanie R / Cicali, Emily J / Seo, Shirley K / Rao, Gauri G

    Clinical pharmacology and therapeutics

    2021  Volume 109, Issue 4, Page(s) 793–796

    MeSH term(s) Communicable Diseases/diagnosis ; Communicable Diseases/drug therapy ; Communicable Diseases/epidemiology ; Humans ; Pharmaceutical Preparations
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2021-03-26
    Publishing country United States
    Document type Editorial ; Comment
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.2208
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  6. Article: Rates of refusal of clinical autopsies among HIV-positive decedents and an overview of autopsies in Uganda.

    Namuju, Olivie C / Kwizera, Richard / Lukande, Robert / Pastick, Katelyn A / Taylor, Jonee M / Nicol, Melanie R / Boulware, David R / Meya, David B

    Wellcome open research

    2022  Volume 6, Page(s) 302

    Abstract: Background: ...

    Abstract Background:
    Language English
    Publishing date 2022-02-01
    Publishing country England
    Document type Journal Article
    ISSN 2398-502X
    ISSN 2398-502X
    DOI 10.12688/wellcomeopenres.17316.2
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  7. Article ; Online: Pharmacogenomics of COVID-19 therapies.

    Takahashi, Takuto / Luzum, Jasmine A / Nicol, Melanie R / Jacobson, Pamala A

    NPJ genomic medicine

    2020  Volume 5, Page(s) 35

    Abstract: A new global pandemic of coronavirus disease 2019 (COVID-19) has resulted in high mortality and morbidity. Currently numerous drugs are under expedited investigations without well-established safety or efficacy data. Pharmacogenomics may allow ... ...

    Abstract A new global pandemic of coronavirus disease 2019 (COVID-19) has resulted in high mortality and morbidity. Currently numerous drugs are under expedited investigations without well-established safety or efficacy data. Pharmacogenomics may allow individualization of these drugs thereby improving efficacy and safety. In this review, we summarized the pharmacogenomic literature available for COVID-19 drug therapies including hydroxychloroquine, chloroquine, azithromycin, remdesivir, favipiravir, ribavirin, lopinavir/ritonavir, darunavir/cobicistat, interferon beta-1b, tocilizumab, ruxolitinib, baricitinib, and corticosteroids. We searched PubMed, reviewed the Pharmacogenomics Knowledgebase (PharmGKB
    Keywords covid19
    Language English
    Publishing date 2020-08-18
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2813848-X
    ISSN 2056-7944 ; 2056-7944
    ISSN (online) 2056-7944
    ISSN 2056-7944
    DOI 10.1038/s41525-020-00143-y
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  8. Article ; Online: Review of Real-World Implementation Data on Emtricitabine-Tenofovir Disoproxil Fumarate as HIV Pre-exposure Prophylaxis in the United States.

    Adams, Jessica L / Shelley, Karishma / Nicol, Melanie R

    Pharmacotherapy

    2019  Volume 39, Issue 4, Page(s) 486–500

    Abstract: The antiretroviral combination of emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) was approved by the U.S. Food and Drug Administration for use as pre-exposure prophylaxis (PrEP) in individuals at high risk for acquiring human immunodeficiency ... ...

    Abstract The antiretroviral combination of emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) was approved by the U.S. Food and Drug Administration for use as pre-exposure prophylaxis (PrEP) in individuals at high risk for acquiring human immunodeficiency virus (HIV) in July 2012. Since then, Centers for Disease Control and Prevention guidelines for the use of PrEP have been published and implemented into clinical practice throughout the United States. A number of published open-label and PrEP demonstration projects have evaluated the real-world use of PrEP including analysis of the barriers to its use and addressing major concerns. Despite the approval of FTC/TDF for PrEP, its use for this indication relies on patient and provider acceptance, and its effectiveness requires patient adherence and retention in care during periods of high-risk behaviors. Concerns regarding the use of PrEP in healthy individuals persist and include medication adverse effects including renal dysfunction and bone mineral density loss; risk compensation leading to HIV infections, sexually transmitted infections, and unintended pregnancies; and the development of drug resistance in the event of seroconversion. The cost-effectiveness of PrEP continues to be assessed with the greatest cost-effectiveness remaining in those at highest risk of acquiring HIV. Additionally, cases of HIV acquisition in individuals who are adherent to PrEP highlight scenarios in which PrEP is not 100% effective including against the transmission of drug-resistant HIV strains. This review examines data on the implementation of PrEP outside the setting of clinical trials with the aim of providing clinicians with a summary of the current barriers and opportunities for PrEP use with a specific focus on the role of pharmacists in the optimization of PrEP implementation.
    MeSH term(s) Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/adverse effects ; Anti-HIV Agents/therapeutic use ; Cost-Benefit Analysis ; Drug Prescriptions/statistics & numerical data ; Drug Resistance, Multiple, Viral ; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination/administration & dosage ; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination/adverse effects ; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination/therapeutic use ; HIV Infections/prevention & control ; HIV Infections/virology ; Humans ; Patient Compliance ; Pre-Exposure Prophylaxis/methods ; Randomized Controlled Trials as Topic
    Chemical Substances Anti-HIV Agents ; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
    Language English
    Publishing date 2019-04-01
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 603158-4
    ISSN 1875-9114 ; 0277-0008
    ISSN (online) 1875-9114
    ISSN 0277-0008
    DOI 10.1002/phar.2240
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    Zs.MO 585: Show issues

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  9. Article ; Online: Casein Kinase 2 Mediates HIV- and Opioid-Induced Pathologic Phosphorylation of TAR DNA Binding Protein 43 in the Basal Ganglia.

    Ohene-Nyako, Michael / Nass, Sara R / Richard, Hope T / Lukande, Robert / Nicol, Melanie R / McRae, MaryPeace / Knapp, Pamela E / Hauser, Kurt F

    ASN neuro

    2023  Volume 15, Page(s) 17590914231158218

    Abstract: Summary statement: HIV/HIV-1 Tat and morphine independently increase pathologic phosphorylation of TAR DNA binding protein 43 in the striatum. HIV- and opioid-induced pathologic phosphorylation of TAR DNA binding protein 43 may involve enhanced CK2 ... ...

    Abstract Summary statement: HIV/HIV-1 Tat and morphine independently increase pathologic phosphorylation of TAR DNA binding protein 43 in the striatum. HIV- and opioid-induced pathologic phosphorylation of TAR DNA binding protein 43 may involve enhanced CK2 activity and protein levels.
    MeSH term(s) Humans ; Phosphorylation ; Casein Kinase II/metabolism ; Analgesics, Opioid/pharmacology ; Analgesics, Opioid/metabolism ; tat Gene Products, Human Immunodeficiency Virus/metabolism ; DNA-Binding Proteins ; HIV-1/metabolism ; Basal Ganglia/metabolism ; HIV Infections ; Protein Binding
    Chemical Substances Casein Kinase II (EC 2.7.11.1) ; Analgesics, Opioid ; tat Gene Products, Human Immunodeficiency Virus ; DNA-Binding Proteins
    Language English
    Publishing date 2023-03-08
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2485467-0
    ISSN 1759-0914 ; 1759-0914
    ISSN (online) 1759-0914
    ISSN 1759-0914
    DOI 10.1177/17590914231158218
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  10. Article: 5-Flucytosine Longitudinal Antifungal Susceptibility Testing of

    McHale, Thomas C / Akampurira, Andrew / Gerlach, Elliot S / Mucunguzi, Atukunda / Nicol, Melanie R / Williams, Darlisha A / Nielsen, Kirsten / Bicanic, Tihana / Fieberg, Ann / Dai, Biyue / Meya, David B / Boulware, David R

    Open forum infectious diseases

    2023  Volume 10, Issue 12, Page(s) ofad596

    Abstract: Background: The EnACT trial was a phase 2 randomized clinical trial conducted in Uganda, which evaluated a novel orally delivered lipid nanocrystal (LNC) amphotericin B in combination with flucytosine for the treatment of cryptococcal meningitis. When ... ...

    Abstract Background: The EnACT trial was a phase 2 randomized clinical trial conducted in Uganda, which evaluated a novel orally delivered lipid nanocrystal (LNC) amphotericin B in combination with flucytosine for the treatment of cryptococcal meningitis. When flucytosine (5FC) is used as monotherapy in cryptococcosis, 5FC can induce resistant
    Methods: We enrolled Ugandans with HIV diagnosed with cryptococcal meningitis and who were randomized to receive 5FC and either standard intravenous (IV) amphotericin B or oral LNC-amphotericin B. We used broth microdilution to measure the minimum inhibitory concentration (MIC) of the first and last cryptococcal isolates in each participant. Breakpoints are inferred from 5FC in
    Results: Cryptococcus
    Conclusions: There is no evidence of baseline resistance to 5FC or incident resistance during combination therapy with oral or IV amphotericin B in Uganda. Oral amphotericin B can safely be used in combination with 5FC.
    Language English
    Publishing date 2023-11-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofad596
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