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
Gulick R., Mellors J., Havlir D., Eron J., Meibohm A., Condra J., Valentine F., McMahon D., Gonzalez C., Jonas L., Emini E., Chodakewitz J., Isaacs R., Richman D.; 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.
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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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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