The Efficacy of Azidothymidine (AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex

Abstract

We conducted a double-blind, placebo-controlled trial of the efficacy of oral azidothymidine (AZT) in 282 patients with the acquired immunodeficiency syndrome (AIDS) manifested by Pneumocystis carinii pneumonia alone, or with advanced AIDS-related complex. The subjects were stratified according to numbers of T cells with CD4 surface markers and were randomly assigned to receive either 250 mg of AZT or placebo by mouth every four hours for a total of 24 weeks. One hundred forty-five subjects received AZT, and 137 received placebo. When the study was terminated, 27 subjects had completed 24 weeks of the study, 152 had completed 16 weeks, and the remainder had completed at least 8 weeks. Nineteen placebo recipients and 1 AZT recipient died during the study (P less than 0.001). Opportunistic infections developed in 45 subjects receiving placebo, as compared with 24 receiving AZT. The base-line Karnofsky performance score and weight increased significantly among AZT recipients (P less than 0.001). A statistically significant increase in the number of CD4 cells was noted in subjects receiving AZT (P less than 0.001). After 12 weeks, the number of CD4 cells declined to pretreatment values among AZT recipients with AIDS but not amonG AZT recipients with AIDS-related complex. Skin-test anergy was partially reversed in 29 percent of subjects receiving AZT, as compared with 9 percent of those receiving placebo (P less than 0.001). These data demonstrate that AZT administration can decrease mortality and the frequency of opportunistic infections in a selected group of subjects with AIDS or AIDS-related complex, at least over the 8 to 24 weeks of observation in this study.

Reinfection results in accumulation of unintegrated viral DNA in cytopathic and persistent human immunodeficiency virus type 1 infection of CEM cells.

“…In addition to its demonstrated value as an antiviral agent for the treatment of HIV-1 infection (36,37), AZT also has the potential to modulate cytopathic HIV-1 infection of T cells to a form'that is persistent and noncytopathic. This feature of drug action is due to inhibiting reinfection of already infected cells and requires lower concentrations of drug than are necessary to inhibit primary infection .…”

Hemophilia treatment in historical perspective: a review of medical and social developments

“…In spite of the tremendous research efforts of the past years, the outlook for those infected with HIV has improved only very little. A benificial effect has been demonstrated for the antiviral agent zidovudine (formerly called AZT), that decreases the occurrence of opportunistic infections and improves survival time in patients with AIDS [46]. In one study zidovudine was also shown to reduce the rate of progression in asymptomatic HIV infected individuals, especially those with low CD4-positive cell counts [142].…”

AZT inhibits the transmission of human T cell leukaemia/lymphoma virus type I to adult peripheral blood mononuclear cells in vitro.

“…common agent prescribed in the treatment of human immunodeficiency virus (HIV) infection in AIDS patients (Fischl et al, 1987 ;Mitsuya et al, 1985).…”