Roy M. Gulick, MD, MPH; John W. Mellors, MD; Diane Havlir, MD; Joseph J. Eron, MD; Anne Meibohm, PhD; Jon H. Condra, PhD; Fred T. Valentine, MD; Deborah McMahon, MD; Charles Gonzalez, MD; Leslie Jonas, BS; Emilio A. Emini, PhD; Jeffrey A. Chodakewitz, MD; Robin Isaacs, MD; Douglas D. Richman, MD
Antiretroviral regimens containing HIV protease inhibitors suppress viremia in HIV-infected patients, but the durability of this effect is not known.
To describe the 3-year follow-up of patients randomly assigned to receive indinavir, zidovudine, and lamivudine in an ongoing clinical trial.
Open-label extension of a randomized, double-blind study.
Four clinical research units.
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.
Indinavir, zidovudine, and lamivudine.
Safety assessments, HIV RNA levels, CD4 cell counts, and genotypic analyses.
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%).
A three-drug regimen of indinavir, zidovudine, and lamivudine suppressed viremia in two thirds of patients for at least 3 years.
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Gulick RM, Mellors JW, Havlir D, Eron JJ, Meibohm A, Condra JH, et al. 3-Year Suppression of HIV Viremia with Indinavir, Zidovudine, and Lamivudine. Ann Intern Med. 2000;133:35-39. doi: 10.7326/0003-4819-133-1-200007040-00007
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Published: Ann Intern Med. 2000;133(1):35-39.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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