2nd National Conference Human Retroviruses and Related Infections Washington, DC - January 29 - February 2, 1995

Natl Conf Hum Retrovir Relat Infect 1995 Jan 29-Feb 2;2: (abstract no. 2)

S.A. Spector, G. McKinley, W.L. Drew, M.J. Stempien for the Syntex Ganciclovir Study Group
University of California - San Diego, CA; St. Luke's-Roosevelt Hospital, N.Y.; Mount Zion Medical Center, San Francisco, CA; and Syntex Research, Palo Alto, CA

This randomized double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of oral ganciclovir (GCV) for the prevention of CMV disease in CMV seropositive, HIV-infected persons with CD4⁺ counts ≤50/µl or with a previous AIDS-defining opportunistic infection and CD4⁺ cells ≤100/µl. Subjects were randomized 2:1 to receive GCV 1000 mg q8h (N=485) or placebo (N=289). Subjects were 99% male with a median age of 39 yars and 94% had previously received antiretroviral therapy; 62% vs 68% had an AIDS diagnosis and the median CD4⁺ count/µl was 21 vs 23 for the GCV and placebo groups, respectively. A planned intent-to-treat interim analysis of all 725 subjects met a pre-defined early stopping criterion. CMV disease occurred in 30% (N=72) of placebo vs 16% (N=76) of GCV subjects (rel. risk 2.2, p=0.0001). Death occurred in 29% (N=66) of placebo recipients vs 22% (N=109) of GCV treated subjects (p=0.08) with a trend toward longer survival in the GCV group (rel. risk 1.4, logrank p=0.052). Oral GCV was generally tolerated well with no differences in GI adverse events. Absolute neutrophil count <500/mm³ occurred in 6% vs 11% for placebo vs GCV, respectively (p=0.0001). This study demonstrates that oral ganciclovir can significantly reduce the incidence of, and time to, CMV disease and may improve survival in HIV-infected persons. The final analsys of this study improve survival in HIV-infected persons. The final analysis of this study will be presented.

Keywords: AIDS Vaccines, Acquired Immunodeficiency Syndrome, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes, Cytomegalovirus, Cytomegalovirus Infections, Cytomegalovirus Retinitis, Disease Progression, Double-Blind Method, Ganciclovir, HIV Infections, HIV Seropositivity, Humans, Male, Opportunistic Infections, Placebos, Safety, therapy

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1995-01-29
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