Rifabutin Versus Placebo in Combination with Three Drugs in the Treatment of Nontuberculous Mycobacterial Infection in Patients with AIDS

Abstract

The aim of this double-blind, randomized, placebo-controlled, 12-week study was to assess the efficacy of rifabutin (450 or 600 mg/d) in the treatment of disseminated nontuberculous mycobacterial infection in patients with AIDS. Companion drugs in both arms of the study were ethambutol, clofazimine, and isoniazid. Because of low accrual, the study was prematurely terminated when a total of 382 patients had been enrolled, of which 200 were eligible (i.e., their specimens were culture-positive for Mycobacterium avium complex [MAC] or Mycobacterium xenopi at baseline) and 102 were evaluable (i.e., they were eligible, were treated for a minimum of 6 weeks, and had at least one culture assessment after baseline). The original protocol called for a total of 220 evaluable patients. At week 12, rifabutin treatment was associated with higher, although nonsignificant, rates of bacteriologic conversion than was the placebo arm, with regard to both the eligible patients (25% vs. 18%) and the evaluable patients (45% vs. 38%). Corresponding median times to culture conversion were 42 vs. 63 days (eligible patients) and 43 vs. 69 days (evaluable patients). No significant difference was observed in clinical improvement, mortality, or toxicity between the two treatment arms. The addition of rifabutin to a triple-drug regimen may contribute to the clearance of disseminated MAC infection in patients with AIDS, without causing additional toxicity.

Application of molecular biology techniques to the diagnosis of nontuberculous mycobacterial infections

“…They often occur with clinical findings mimicking tuberculosis (24). Yet, antituberculous regimens are frequently ineffective in the treatment of these infections (25)(26)(27). Therefore, correct and rapid identification of the species isolated is important for evaluation of the clinical significance and initiation of the correct therapy.…”

In Vitro and In Vivo Activities of New Rifamycin Derivatives Against Mycobacterial Infections

“…Dautzenberg and his colleagues [32] reported a doubleblind, placebo-controlled trial in which RFB given for 12 weeks at 450 or 600 mg/day was used for the treatment of disseminated M. avium infection in AIDS patients. Companion drugs in both arms of the study were EMB, clofazimine and INH.…”

“…No significant difference was observed in clinical improvement, mortality, or toxicity between the two treatment arms. The addition of RFB to a triple-drug regimen may contribute to the clearance of disseminated M. avium infection in patients with AIDS, without causing additional toxicity [32].…”

Management of Infection With Nontuberculosis Mycobacteria

“…The CD count is usually low (<50), and the patient has clinical signs of advanced disease (18). Patients are usually febrile and wasted and with significant anemia.…”