An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate
| Autor: | Jill L. Schwartz, Timothy H. Holtz, Ian McGowan, Craig W. Hendrix, Marcel E. Curlin, Mark A. Marzinke, Gustavo F. Doncel, Ratiya Pamela Kunjara Na Ayudhya, Rhonda M. Brand, James F. Rooney, Boonyos Raengsakulrach, Anupong Chitwarakorn, Ross D Cranston, Jeanna M. Piper, Sherri Johnson |
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| Rok vydání: | 2022 |
| Předmět: |
Male
Tenofovir Anti-HIV Agents Immunology Human immunodeficiency virus (HIV) HIV Infections Pharmacology medicine.disease_cause Emtricitabine Sexual and Gender Minorities Pharmacokinetics Virology Microbicide Emtricitabine/Tenofovir Disoproxil Fumarate medicine Humans Clinical Trials/Clinical Studies Homosexuality Male Cross-Over Studies business.industry virus diseases Infectious Diseases Pharmacodynamics HIV-1 Reverse Transcriptase Inhibitors Female Pre-Exposure Prophylaxis Open label business medicine.drug |
| Zdroj: | AIDS Res Hum Retroviruses |
| ISSN: | 1931-8405 0889-2229 |
| DOI: | 10.1089/aid.2021.0115 |
| Popis: | The Microbicide Trials Network-017 study was undertaken to characterize the safety, acceptability, pharmacokinetic (PK), and pharmacodynamic profile of the reduced-glycerin (RG) 1% tenofovir (RG-TFV) gel compared to oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). The study was a Phase 2, three-period, randomized sequence, open-label, expanded safety and acceptability crossover study. In each 8-week study period, HIV-1-uninfected participants were randomized to RG-TFV rectal gel daily or RG-TFV rectal gel before and after receptive anal intercourse (RAI) (or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. A mucosal substudy was conducted at sites in the United States and Thailand. Samples were collected to evaluate PK and ex vivo biopsy challenge with HIV-1. A total of 195 men who have sex with men and transgender women were enrolled in the parent study and 37 in the mucosal substudy. As previously reported, both products were found to be safe and acceptable. Systemic TFV concentrations were significantly higher following oral exposure and daily rectal administration compared to RAI-associated product use (p |
| Databáze: | OpenAIRE |
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