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3-Year Suppression of HIV Viremia with Indinavir, Zidovudine, and Lamivudine

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; and Douglas D. Richman, MD
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Copyright ©2004 by the American College of Physicians

Ann Intern Med. 2000;133(1):35-39. doi:10.7326/0003-4819-133-1-200007040-00007
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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.


Grahic Jump Location
Figure 1.
Proportion of patients with serum HIV RNA levels less than 500 copies/mL and less than 50 copies/mL during 3 years of treatment with indinavir, zidovudine, and lamivudine.

Squares represent proportions with levels less than 500 copies/mL; triangles represent proportions with levels less than 50 copies/mL; error bars represent 95% CIs.

Grahic Jump Location
Grahic Jump Location
Figure 2.
Median changes in serum HIV RNA level and CD4 cell count from baseline during 3 years of treatment with indinavir, zidovudine, and lamivudine.

Error bars represent the 25th and 75th percentiles.

Grahic Jump Location




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Summary for Patients

Anti-HIV Drugs Continue To Fight HIV Infection after 3 Years

Copyright ©2004 by the American College of Physicians


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