OBJECTIVE: To determine whether HIV-1 genotyping and expert advice add additional short-term virologic benefit in guiding antiretroviral changes in HIV+ drug-experienced patients. DESIGN: A two factorial (genotyping and expert advice), randomized, open label, multi-center trial. The patients were stratified according to the number of treatment failures. PATIENTS AND METHODS: HIV-1 infected patients on stable antiretroviral therapy who presented virological failure were included into the study. Genotypic testing was performed by using TrueGene HIV Genotyping kit and the results were interpreted by a software package (RetroGram, version 1.0). An expert advisory committee suggested the new therapeutic approach based on clinical information alone or on clinical information plus HIV-1 genotyping results. Plasma HIV-1 RNA load, CD4+ cell count and adverse events were recorded at baseline and every 12 weeks. RESULTS:A total of 326 patients were included. The baseline CD4+ cell count and plasma HIV-1 RNA were 387 (+/- 224) x 10(6) cells/l and 4 (+/- 1) log(10) respectively. The proportion of patients with plasma HIV-1 RNA <; 400 copies/ml at 24 weeks differed between genotyping and no genotyping arms (48.5 and 36.2%, P < 0.05). Factors associated with a higher probability of plasma HIV-1 RNA < 400 copies/ml were HIV-1 genotyping [odds ratio (OR), 1.7; 95% confidence interval (CI), 1.1-2.8; P = 0.016] and the expert advice in patients failing to a second-line antiretroviral therapy (OR, 3.2; 95% CI, 1.2-8.3; P = 0.016). CONCLUSIONS: HIV-1 genotyping interpreted by a software package improves the virological outcome when it is added to the clinical information as a basis for decisions on changing antiretroviral therapy. The expert advice also showed virologic benefit in the second failure group.
RCT Entities:
OBJECTIVE: To determine whether HIV-1 genotyping and expert advice add additional short-term virologic benefit in guiding antiretroviral changes in HIV+ drug-experienced patients. DESIGN: A two factorial (genotyping and expert advice), randomized, open label, multi-center trial. The patients were stratified according to the number of treatment failures. PATIENTS AND METHODS: HIV-1 infectedpatients on stable antiretroviral therapy who presented virological failure were included into the study. Genotypic testing was performed by using TrueGene HIV Genotyping kit and the results were interpreted by a software package (RetroGram, version 1.0). An expert advisory committee suggested the new therapeutic approach based on clinical information alone or on clinical information plus HIV-1 genotyping results. Plasma HIV-1 RNA load, CD4+ cell count and adverse events were recorded at baseline and every 12 weeks. RESULTS: A total of 326 patients were included. The baseline CD4+ cell count and plasma HIV-1 RNA were 387 (+/- 224) x 10(6) cells/l and 4 (+/- 1) log(10) respectively. The proportion of patients with plasma HIV-1 RNA < 400 copies/ml at 24 weeks differed between genotyping and no genotyping arms (48.5 and 36.2%, P < 0.05). Factors associated with a higher probability of plasma HIV-1 RNA < 400 copies/ml were HIV-1 genotyping [odds ratio (OR), 1.7; 95% confidence interval (CI), 1.1-2.8; P = 0.016] and the expert advice in patients failing to a second-line antiretroviral therapy (OR, 3.2; 95% CI, 1.2-8.3; P = 0.016). CONCLUSIONS:HIV-1 genotyping interpreted by a software package improves the virological outcome when it is added to the clinical information as a basis for decisions on changing antiretroviral therapy. The expert advice also showed virologic benefit in the second failure group.
Authors: Rafael E Campo; Paola N Lichtenberger; Isabella Rosa; German Suarez; Fernando A Rivera; Allan E Rodriguez; Dushyantha T Jayaweera; Natalie A Wahlay; Michael A Kolber Journal: J Clin Microbiol Date: 2003-07 Impact factor: 5.948
Authors: Galina N Nikolenko; Sarah Palmer; Frank Maldarelli; John W Mellors; John M Coffin; Vinay K Pathak Journal: Proc Natl Acad Sci U S A Date: 2005-01-31 Impact factor: 11.205
Authors: H H Hirsch; H Drechsler; A Holbro; F Hamy; P Sendi; K Petrovic; T Klimkait; M Battegay Journal: Eur J Clin Microbiol Infect Dis Date: 2005-11 Impact factor: 3.267
Authors: Joke Snoeck; Rami Kantor; Robert W Shafer; Kristel Van Laethem; Koen Deforche; Ana Patricia Carvalho; Brian Wynhoven; Marcelo A Soares; Patricia Cane; John Clarke; Candice Pillay; Sunee Sirivichayakul; Koya Ariyoshi; Africa Holguin; Hagit Rudich; Rosangela Rodrigues; Maria Belen Bouzas; Françoise Brun-Vézinet; Caroline Reid; Pedro Cahn; Luis Fernando Brigido; Zehava Grossman; Vincent Soriano; Wataru Sugiura; Praphan Phanuphak; Lynn Morris; Jonathan Weber; Deenan Pillay; Amilcar Tanuri; Richard P Harrigan; Ricardo Camacho; Jonathan M Schapiro; David Katzenstein; Anne-Mieke Vandamme Journal: Antimicrob Agents Chemother Date: 2006-02 Impact factor: 5.191
Authors: Mark J Siedner; Mwebesa B Bwana; Mahomed-Yunus S Moosa; Michelle Paul; Selvan Pillay; Suzanne McCluskey; Isaac Aturinda; Kevin Ard; Winnie Muyindike; Pravikrishnen Moodley; Jaysingh Brijkumar; Tamlyn Rautenberg; Gavin George; Brent Johnson; Rajesh T Gandhi; Henry Sunpath; Vincent C Marconi Journal: HIV Clin Trials Date: 2017-07-18
Authors: Y Yazdanpanah; M Vray; J Meynard; E Losina; M C Weinstein; L Morand-Joubert; S J Goldie; H E Hsu; R P Walensky; C Dalban; P E Sax; P M Girard; K A Freedberg Journal: HIV Med Date: 2007-10 Impact factor: 3.180