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Previous Volume 348:2175-2185 May 29, 2003 Number 22 Next

	Full Text PDF PDA Full Text Perspective by Steinbrook, R. Editorial by Tashima, K. T. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

ABSTRACT

Background The T-20 vs. Optimized Regimen Only Study 1 (TORO 1) was a randomized, open-label, phase 3 study of enfuvirtide (T-20), a human immunodeficiency virus type 1 (HIV-1) fusion inhibitor.

Methods Patients from 48 sites in the United States, Canada, Mexico, and Brazil with at least six months of previous treatment with agents in three classes of antiretroviral drugs, resistance to drugs in these classes, or both, and with at least 5000 copies of HIV-1 RNA per milliliter of plasma were randomly assigned in a 2:1 ratio to receive enfuvirtide plus an optimized background regimen of three to five antiretroviral drugs or such a regimen alone (control group). The primary efficacy end point was the change in the plasma HIV-1 RNA level from base line to week 24.

Results A total of 501 patients underwent randomization, and 491 received at least one dose of study drug and had at least one measurement of plasma HIV-1 RNA after treatment began. The two groups were balanced in terms of the median base-line HIV-1 RNA level (5.2 log₁₀ copies per milliliter in both groups), median CD4+ cell count (75.5 cells per cubic millimeter in the enfuvirtide group, and 87.0 cells per cubic millimeter in the control group), demographic characteristics, and previous antiretroviral therapy. At 24 weeks, the least-squares mean change from base line in the viral load (intention-to-treat, last observation carried forward) was a decrease of 1.696 log₁₀ copies per milliliter in the enfuvirtide group, and a decrease of 0.764 log₁₀ copies per milliliter in the control group (P<0.001). The mean increases in CD4+ cell count were 76 cells per cubic millimeter and 32 cells per cubic millimeter, respectively (P<0.001). Reactions at the site of the injections were reported by 98 percent of patients receiving enfuvirtide. There were more cases of pneumonia in the enfuvirtide group than in the control group.

Conclusions The addition of enfuvirtide to an optimized antiretroviral regimen provided significant antiretroviral and immunologic benefit through 24 weeks in patients who had previously received multiple antiretroviral drugs and had multidrug-resistant HIV-1 infection.

Source Information

From Quest Clinical Research, Mount Zion Hospital, and the University of California, San Francisco, San Francisco (J.P.L.); the HIV Program, Hennepin County Medical Center, Minneapolis (K.H.); the Oregon Health and Science University, Portland (M.O.); St. Paul's Hospital and the University of British Columbia, Vancouver, Canada (J.S.G.M.); the Clinical Research Initiative, Albany Medical College, Albany, N.Y. (P.J.P.); the Clinique Médicale l'Actuel, Montreal (B.T.); the University of Toronto, Toronto (S.W.); the Community Research Initiative of New England, Boston (C.C.); the Division of Infectious Diseases, University of Colorado Health Sciences Center, Denver (D.R.K.); the University of North Carolina at Chapel Hill School of Medicine, Chapel Hill (J.J.E.); Roche, Nutley, N.J. (J.C., L.D., M.S.); and Trimeris, Durham, N.C. (R.D., C.D., J.D.).

This article was published at www.nejm.org on March 13, 2003.

Address reprint requests to Dr. Lalezari at Quest Clinical Research, 2300 Sutter St., Suite 202, San Francisco, CA 94115, or at drjay{at}questclinical.com.

Full Text of this Article

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Enfuvirtide, an HIV-1 Fusion Inhibitor
Carr A., Jenny-Avital E. R., Lalezari J. P., Lazzarin A., Salgo M.
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N Engl J Med 2003; 349:1770-1771, Oct 30, 2003. Correspondence

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