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
Scott M. Hammer, M.D., Kathleen E. Squires, M.D., Michael D. Hughes, Ph.D., Janet M. Grimes, M.S., Lisa M. Demeter, M.D., Judith S. Currier, M.D., Joseph J. Eron, M.D., Judith E. Feinberg, M.D., Henry H. Balfour, M.D., Lawrence R. Deyton, M.D., Jeffrey A. Chodakewitz, M.D., Margaret A. Fischl, M.D., John P. Phair, M.D., Louise Pedneault, M.D., Bach-Yen Nguyen, M.D., Jon C. Cook, B.Sc., for The AIDS Clinical Trials Group 320 Study Team
Background The efficacy and safety of adding a protease inhibitorto two nucleoside analogues to treat human immunodeficiencyvirus type 1 (HIV-1) infection are not clear. We compared treatmentwith the protease inhibitor indinavir in addition to zidovudineand lamivudine with treatment with the two nucleosides alonein HIV-infected adults previously treated with zidovudine.
Methods A total of 1156 patients not previously treated withlamivudine or protease inhibitors were stratified accordingto CD4 cell count (50 or fewer vs. 51 to 200 cells per cubicmillimeter) and randomly assigned to one of two daily regimens:600 mg of zidovudine and 300 mg of lamivudine, or that regimenwith 2400 mg of indinavir. Stavudine could be substituted forzidovudine. The primary end point was the time to the developmentof the acquired immunodeficiency syndrome (AIDS) or death.
Results The proportion of patients whose disease progressedto AIDS or death was lower with indinavir, zidovudine (or stavudine),and lamivudine (6 percent) than with zidovudine (or stavudine)and lamivudine alone (11 percent; estimated hazard ratio, 0.50;95 percent confidence interval, 0.33 to 0.76; P = 0.001). Mortalityin 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 similarin both CD4 cell strata. The responses of CD4 cells and plasmaHIV-1 RNA paralleled the clinical results.
Conclusions Treatment with indinavir, zidovudine, and lamivudineas compared with zidovudine and lamivudine alone significantlyslows the progression of HIV-1 disease in patients with 200CD4 cells or fewer per cubic millimeter and prior exposure tozidovudine.
Source Information
From Harvard Medical School, Boston (S.M.H.); the University of Alabama at Birmingham, Birmingham (K.E.S.); the London School of Hygiene and Tropical Medicine, London (M.D.H.); Harvard School of Public Health, Boston (M.D.H., J.M.G.); the University of Rochester, Rochester, N.Y. (L.M.D.); the University of Southern California, Los Angeles (J.S.C.); the University of North Carolina, Chapel Hill (J.J.E.); the University of Cincinnati, Cincinnati (J.E.F.); the University of Minnesota, Minneapolis (H.H.B.); the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Md. (L.R.D.); Merck and Co., West Point, Pa. (J.A.C.); and the University of Miami, Miami (M.A.F.). Other authors were John P. Phair, M.D. (Northwestern University), William Spreen, Pharm.D. (Glaxo–Wellcome), Louise Pedneault, M.D. (Bristol-Myers Squibb), Bach-Yen Nguyen, M.D. (Merck), and Jon C. Cook, B.Sc. (AIDS Clinical Trials Group Operations Center).Drs. Hammer, Squires, Hughes, Demeter, Currier, Eron, Feinberg, Balfour, Fischl, and Phair have served as ad hoc consultants for, or received honorariums or research grants from, one or more of the pharmaceutical firms whose products were studied (Merck, Glaxo–Wellcome, and Bristol-Myers Squibb).
Address reprint requests to Dr. Hammer at the Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 1 Deaconess Rd., Boston, MA 02215.
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Cole, S. R., Hernan, M. A., Robins, J. M., Anastos, K., Chmiel, J., Detels, R., Ervin, C., Feldman, J., Greenblatt, R., Kingsley, L., Lai, S., Young, M., Cohen, M., Munoz, A.
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