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Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1.

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Title: Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1.
Authors: Hillier SL; Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Research Institute and Foundation, Pittsburgh, Pennsylvania, USA.; Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA., Bekker LG; Department of Medicine, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., Riddler SA; Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA., Hendrix CW; Department of Medicine (Clinical Pharmacology), The John Hopkins Hospital, Baltimore, Maryland, USA., Badal-Faesen S; Clinical HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa., Macdonald P; Department of Medicine, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., Nair G; Department of Medicine, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., Lombaard J; Research and Development, Josha Research, Bloemfontein, South Africa., Caraco Y; Clinical Pharmacology Unit, Division of Medicine, Hadassah Medical Center, Jerusalem, Israel., Peer A; Department of Oncology, Rambam Health Care Campus, Haifa, Israel., Patel M; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Vargo R; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Homony B; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Nedrow K; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Evans B; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Wickremasingha P; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Zhou YP; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Teal V; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Hwang P; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., McMullan C; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Kaufman KD; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Robertson MN; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA., Plank RM; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.
Source: The Journal of infectious diseases [J Infect Dis] 2025 Nov 14; Vol. 232 (5), pp. 1050-1060.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase II
Journal Info: Publisher: Oxford University Press Country of Publication: United States NLM ID: 0413675 Publication Model: Print Cited Medium: Internet ISSN: 1537-6613 (Electronic) Linking ISSN: 00221899 NLM ISO Abbreviation: J Infect Dis Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1.
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  Data: <searchLink fieldCode="AU" term="%22Hillier+SL%22">Hillier SL</searchLink>; Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Research Institute and Foundation, Pittsburgh, Pennsylvania, USA.; Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Bekker+LG%22">Bekker LG</searchLink>; Department of Medicine, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Riddler+SA%22">Riddler SA</searchLink>; Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Hendrix+CW%22">Hendrix CW</searchLink>; Department of Medicine (Clinical Pharmacology), The John Hopkins Hospital, Baltimore, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Badal-Faesen+S%22">Badal-Faesen S</searchLink>; Clinical HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Macdonald+P%22">Macdonald P</searchLink>; Department of Medicine, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Nair+G%22">Nair G</searchLink>; Department of Medicine, Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.<br /><searchLink fieldCode="AU" term="%22Lombaard+J%22">Lombaard J</searchLink>; Research and Development, Josha Research, Bloemfontein, South Africa.<br /><searchLink fieldCode="AU" term="%22Caraco+Y%22">Caraco Y</searchLink>; Clinical Pharmacology Unit, Division of Medicine, Hadassah Medical Center, Jerusalem, Israel.<br /><searchLink fieldCode="AU" term="%22Peer+A%22">Peer A</searchLink>; Department of Oncology, Rambam Health Care Campus, Haifa, Israel.<br /><searchLink fieldCode="AU" term="%22Patel+M%22">Patel M</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Vargo+R%22">Vargo R</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Homony+B%22">Homony B</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Nedrow+K%22">Nedrow K</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Evans+B%22">Evans B</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Wickremasingha+P%22">Wickremasingha P</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Zhou+YP%22">Zhou YP</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Teal+V%22">Teal V</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Hwang+P%22">Hwang P</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22McMullan+C%22">McMullan C</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Kaufman+KD%22">Kaufman KD</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Robertson+MN%22">Robertson MN</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Plank+RM%22">Plank RM</searchLink>; MRL Research Laboratories, Merck & Co., Inc., Rahway, New Jersey, USA.
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  Data: <searchLink fieldCode="JN" term="%220413675%22">The Journal of infectious diseases</searchLink> [J Infect Dis] 2025 Nov 14; Vol. 232 (5), pp. 1050-1060.
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