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Previous Volume 334:426-431 February 15, 1996 Number 7 Next

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ABSTRACT

Background Clinical trials of antiretroviral drugs can take years to complete because the outcomes measured are progression to the acquired immunodeficiency syndrome (AIDS) or death. Trials could be accelerated by the use of end points such as changes in CD4+ lymphocyte counts and plasma levels of human immunodeficiency virus type 1 (HIV-1) RNA and ₂-microglobulin, but there is uncertainty about whether these surrogate measures are valid predictors of disease progression.

Methods We analyzed data from the Veterans Affairs Cooperative Study on AIDS, which compared immediate with deferred zidovudine therapy. Patients' plasma levels of HIV-1 RNA and ₂-microglobulin were measured in stored plasma.

Results Among the 129 patients in the immediate-treatment group, 34 had disease that progressed to AIDS, as compared with 57 of the 141 patients in the deferred-treatment group (P = 0.03). Progression to AIDS correlated strongly with base-line CD4+ lymphocyte counts (P = 0.001) and plasma levels of HIV-1 RNA (P<0.001), but not with base-line levels of ₂-microglobulin (P = 0.14). A decrease of at least 75 percent in the plasma level of HIV-1 RNA over the first six months of zidovudine therapy accounted for 59 percent of the benefit of treatment, defined as the absence of progression to AIDS (95 percent confidence interval, 13 to 112 percent). Plasma ₂-microglobulin levels and CD4+ lymphocyte counts explained less of the effect of treatment. A 75 percent decrease in the plasma HIV-1 RNA level plus a 10 percent increase in the CD4+ lymphocyte count could explain 79 percent of the treatment effect (95 percent confidence interval, 27 to 145 percent).

Conclusions Treatment-induced changes in the plasma HIV-1 RNA level and the CD4+ lymphocyte count, taken together, are valid predictors of the clinical progression of HIV-related disease and can be used to assess the efficacy of zidovudine and possibly other antiretroviral drugs as well.

Source Information

From the Department of Medicine, West Los Angeles Veterans Affairs Medical Center and University of California at Los Angeles Medical School, Los Angeles (W.A.O.); the Veterans Affairs Cooperative Studies Program Coordinating Center, West Haven, Conn. (P.M.H.); the University of North Carolina, Chapel Hill (D.M.); Glaxo, Inc., Research Triangle Park, N.C. (J.E., A.H., S.B., M.R.); the New York Veterans Affairs Medical Center and New York University School of Medicine, New York (M.S.S.); and the Durham, N.C., Veterans Affairs Medical Center and Duke University Medical Center, Durham, N.C. (J.D.H.). Presented in part at the 10th International Conference on AIDS, Yokohama, Japan, August 7–12, 1994, and the 2nd National Conference on Human Retroviruses and Related Infections, Washington, D.C., January 29–February 2, 1995.

Address reprint requests to Dr. O'Brien at the West Los Angeles VA Medical Center, 11301 Wilshire Blvd., Los Angeles, CA 90073.

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N Engl J Med 1996; 334:1671-1673, Jun 20, 1996. Correspondence

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