A Randomized Trial of Clarithromycin as Prophylaxis against DisseminatedMycobacterium aviumComplex Infection in Patients with Advanced Acquired Immunodeficiency Syndrome

Abstract

Background Disseminated infection with Mycobacterium avium complex is the most common opportunistic infection in patients with advanced stages of the acquired immunodeficiency syndrome (AIDS). We studied the efficacy and safety of prophylactic treatment with clarithromycin, a macrolide antibiotic. MethodsWe conducted a randomized, placebocontrolled, double-blind study of clarithromycin in patients with AIDS in the United States and Europe. Entry criteria included blood cultures that were negative for M. avium complex, a Karnofsky performance score of 50 or higher, a CD4 cell count of 100 or less per cubic millimeter, and a life expectancy of at least six months.

The therapy of gastrointestinal infections associated with the acquired immunodeficiency syndrome

“…However, side-effects were signi®cantly more common with the multidrug regimen (15.3% vs. 6% vs. 2.3%). As with the previous study, 159 patients developing clinical disease while on azithromycin had developed in vitro resistance. These studies in combination suggest that the preferred therapy for prophylaxis should consist of a macrolide antibiotic, probably clarithromycin 500 mg b.d.…”

“…157 Based on this evidence, rifabutin was recommended for AIDS patients with CD4 count < 50/mm 3 . 158 More recently, prophylaxis trials have compared clarithromycin to placebo, 159 and azithromycin to rifabutin vs. the combination of these two agents. 160 These studies show clarithromycin to be highly effective as monotherapy with a 6 month incidence of infection of 6% as compared to 16% for placebo.…”

Early participation in an HIV cohort study slows disease progression and improves survival

“…However, a recent meta-analysis [23] of a large number of studies indicates that effective prophylactic regimens using trimethoprim-sulfamethoxazol reduces mortality amongst patients with advanced HIV infection. Prophylaxis against Mycobacterium avium complex disease has also been shown to reduce mortality [24]. Antiretroviral monotherapy confers only a limited and transient survival benefit [25,26], but substantial reductions in mortality have been shown in recent clinical trials of regimens, including several nucleoside analogues or nucleoside analogues and protease inhibitors [9][10][11][12][13].…”

Spectrum and Clinical Course of Visual Field Abnormalities in Ethambutol Toxicity

“…In patients with acquired immunodeficiency syndrome and a CD4 count of less than <50 cells per cubic millimetre, 30-50% will eventually develop a severe, disseminated MAC infection. [13][14][15] Therefore, familiarity of the visual consequences of ethambutol is necessary by prescribers and ophthalmologists alike.…”