A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team.

The efficacy and safety of adding a protease inhibitor to two nucleoside analogues to treat human immunodeficiency virus type 1 (HIV-1) infection are not clear. We compared treatment with the protease inhibitor indinavir in addition to zidovudine and lamivudine with treatment with the two nucleosides alone in HIV-infected adults previously treated with zidovudine.
A total of 1156 patients not previously treated with lamivudine or protease inhibitors were stratified according to CD4 cell count (50 or fewer vs. 51 to 200 cells per cubic millimeter) and randomly assigned to one of two daily regimens: 600 mg of zidovudine (or stavudine) and 300 mg of lamivudine, or that regimen with 2400 mg of indinavir. The primary end point was the time to the development of the acquired immunodeficiency syndrome (AIDS) or death.
The proportion of patients whose disease progressed to AIDS or death was lower with indinavir, zidovudine, and lamivudine (6 percent) than with zidovudine and lamivudine alone (11 percent; estimated hazard ratio, 0.50; 95 percent confidence interval, 0.33 to 0.76; P=0.001). Mortality in the two groups was 1.4 percent and 3.1 percent, respectively (estimated hazard ratio, 0.43; 95 percent confidence interval, 0.19 to 0.99; P=0.04). The effects of treatment were similar in both CD4 cell strata. The responses of CD4 cells and plasma HIV-1 RNA paralleled the clinical results.
Treatment with indinavir, zidovudine, and lamivudine as compared with zidovudine and lamivudine alone significantly slows the progression of HIV-1 disease in patients with 200 CD4 cells or fewer per cubic millimeter and prior exposure to zidovudine.
AuthorsS M Hammer, K E Squires, M D Hughes, J M Grimes, L M Demeter, J S Currier, J J Eron Jr, J E Feinberg, H H Balfour Jr, L R Deyton, J A Chodakewitz, M A Fischl
JournalThe New England journal of medicine (N Engl J Med) Vol. 337 Issue 11 Pg. 725-33 (Sep 11 1997) ISSN: 0028-4793 [Print] UNITED STATES
PMID9287227 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Anti-HIV Agents
  • HIV Protease Inhibitors
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Lamivudine
  • Zidovudine
  • Indinavir
  • Stavudine
  • Acquired Immunodeficiency Syndrome (prevention & control)
  • Adult
  • Anti-HIV Agents (adverse effects, therapeutic use)
  • CD4 Lymphocyte Count
  • Disease Progression
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • HIV Infections (drug therapy, immunology, mortality)
  • HIV Protease Inhibitors (adverse effects, therapeutic use)
  • HIV-1
  • Humans
  • Indinavir (adverse effects, therapeutic use)
  • Lamivudine (adverse effects, therapeutic use)
  • Male
  • RNA, Viral (blood)
  • Reverse Transcriptase Inhibitors (therapeutic use)
  • Stavudine (adverse effects, therapeutic use)
  • Zidovudine (adverse effects, therapeutic use)

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