1. GENOPHAR: a randomized study of plasma drug measurements in association with genotypic resistance testing and expert advice to optimize therapy in patients failing antiretroviral therapy*
- Author
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Anne Simon, Manuela Bonmarchand, Vincent Calvez, L. Paris, Dominique Costagliola, C Lamotte, Hocine Ait-Mohand, Nadine Ktorza, Philippe Bossi, Constance Delaugerre, A-G Marcelin, D-J David, Gilles Peytavin, R Cacace, François Bricaire, and Christine Katlama
- Subjects
Adult ,Male ,Drug ,medicine.medical_specialty ,Multivariate analysis ,Adolescent ,Genotype ,Anti-HIV Agents ,media_common.quotation_subject ,Statistics, Nonparametric ,law.invention ,Drug Resistance, Multiple, Viral ,Randomized controlled trial ,law ,Antiretroviral Therapy, Highly Active ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Pharmacology (medical) ,Prospective Studies ,Treatment Failure ,Aged ,media_common ,medicine.diagnostic_test ,business.industry ,Health Policy ,Middle Aged ,Viral Load ,Surgery ,Regimen ,Infectious Diseases ,Therapeutic drug monitoring ,Toxicity ,HIV-1 ,Female ,Drug Monitoring ,business ,Viral load - Abstract
Objectives To evaluate the benefits of therapeutic drug monitoring (TDM) in association with genotypic resistance testing and expert advice to optimize therapy in multiexperienced patients infected with HIV-1. Methods Patients with a viral load>1000 HIV-1 RNA copies/mL and an unchanged antiretroviral therapy regimen over the last 3 months were randomized into two groups: a genotypic group (G) and a geno-pharmacological group (GP). Treatment was selected by an expert committee according to genotypic resistance testing (the G and GP groups) and TDM (the GP group) at week 4. Treatment could be modified at each visit according to toxicity, poor virological response and TDM. Results of TDM were withheld from the G group until week 12. The primary endpoint of the study was the percentage of patients with viral load
- Published
- 2004
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