BACKGROUND: Antiretroviral regimens containing HIV protease inhibitors suppress viremia in HIV-infected patients, but the durability of this effect is not known. OBJECTIVE: To describe the 3-year follow-up of patients randomly assigned to receive indinavir, zidovudine, and lamivudine in an ongoing clinical trial. DESIGN: Open-label extension of a randomized, double-blind study. SETTING: Four clinical research units. PATIENTS: 33 HIV-infected, zidovudine-experienced patients with serum HIV RNA levels of at least 20,000 copies/mL and CD4 counts ranging from 50 to 400 cells/mm3. INTERVENTION: Indinavir, zidovudine, and lamivudine. MEASUREMENTS: Safety assessments, HIV RNA levels, CD4 cell counts, and genotypic analyses. RESULTS: After 3 years of follow-up, 21 of 31 contributing patients (68% [95% CI, 49% to 83%]) had serum viral load levels less than 500 copies/mL. Twenty of 31 (65% [CI, 45% to 80%]) had levels less than 50 copies/mL. The median increase in CD4 count from baseline was 230 cells/mm3 (interquartile range, 150 to 316 cells/mm3). Nephrolithiasis occurred in 12 of 33 patients (36%). CONCLUSION: A three-drug regimen of indinavir, zidovudine, and lamivudine suppressed viremia in two thirds of patients for at least 3 years.
RCT Entities:
BACKGROUND: Antiretroviral regimens containing HIV protease inhibitors suppress viremia in HIV-infectedpatients, but the durability of this effect is not known. OBJECTIVE: To describe the 3-year follow-up of patients randomly assigned to receive indinavir, zidovudine, and lamivudine in an ongoing clinical trial. DESIGN: Open-label extension of a randomized, double-blind study. SETTING: Four clinical research units. PATIENTS: 33 HIV-infected, zidovudine-experienced patients with serum HIV RNA levels of at least 20,000 copies/mL and CD4 counts ranging from 50 to 400 cells/mm3. INTERVENTION: Indinavir, zidovudine, and lamivudine. MEASUREMENTS: Safety assessments, HIV RNA levels, CD4 cell counts, and genotypic analyses. RESULTS: After 3 years of follow-up, 21 of 31 contributing patients (68% [95% CI, 49% to 83%]) had serum viral load levels less than 500 copies/mL. Twenty of 31 (65% [CI, 45% to 80%]) had levels less than 50 copies/mL. The median increase in CD4 count from baseline was 230 cells/mm3 (interquartile range, 150 to 316 cells/mm3). Nephrolithiasis occurred in 12 of 33 patients (36%). CONCLUSION: A three-drug regimen of indinavir, zidovudine, and lamivudine suppressed viremia in two thirds of patients for at least 3 years.
Authors: Rieneke M E van Praag; Elisabeth C M van Weert; Rolf P G van Heeswijk; Xiao-Jian Zhou; Jean-Pierre Sommadossi; Suzanne Jurriaans; Joep M A Lange; Richard M W Hoetelmans; Jan M Prins Journal: Antimicrob Agents Chemother Date: 2002-03 Impact factor: 5.191
Authors: A A Pilon; J J Lum; J Sanchez-Dardon; B N Phenix; R Douglas; A D Badley Journal: Antimicrob Agents Chemother Date: 2002-08 Impact factor: 5.191
Authors: A S Bergshoeff; P L A Fraaij; A M C van Rossum; G Verweel; L H Wynne; G A Winchell; R Y Leavitt; B-Y T Nguyen; R de Groot; D M Burger Journal: Antimicrob Agents Chemother Date: 2004-05 Impact factor: 5.191
Authors: Martina Hennessy; D Kelleher; J P Spiers; M Barry; P Kavanagh; D Back; F Mulcahy; J Feely Journal: Br J Clin Pharmacol Date: 2002-01 Impact factor: 4.335
Authors: Mary Clare Masters; Karen M Krueger; Janna L Williams; Lindsay Morrison; Susan E Cohn Journal: Expert Rev Clin Pharmacol Date: 2019-12 Impact factor: 5.045
Authors: Maloy Kumar Parai; David J Huggins; Hong Cao; Madhavi N L Nalam; Akbar Ali; Celia A Schiffer; Bruce Tidor; Tariq M Rana Journal: J Med Chem Date: 2012-07-13 Impact factor: 7.446
Authors: Diane V Havlir; Matthew C Strain; Mario Clerici; Caroline Ignacio; Daria Trabattoni; Pasquale Ferrante; Joseph K Wong Journal: J Virol Date: 2003-10 Impact factor: 5.103
Authors: Andrey Yu Kovalevsky; Yunfeng Tie; Fengling Liu; Peter I Boross; Yuan-Fang Wang; Sofiya Leshchenko; Arun K Ghosh; Robert W Harrison; Irene T Weber Journal: J Med Chem Date: 2006-02-23 Impact factor: 7.446