Document 1216
 DOCN  M9591216
 TI    Clinical experience with atovaquone on a treatment investigational new
       drug protocol for Pneumocystis carinii pneumonia.
 DT    9509
 AU    White A; LaFon S; Rogers M; Andrews E; Brown N; Department of
       Epidemiology, Burroughs Wellcome Co., Research; Triangle Park, North
       Carolina 27709, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Jul 1;9(3):280-5.
       Unique Identifier : AIDSLINE MED/95308204
 AB    The clinical experience of human immunodeficiency virus (HIV) + patients
       treated with oral atovaquone for acute Pneumocytstis carinii pneumonia
       (PCP) under a Treatment Investigational New Drug (IND) protocol (mild or
       moderate PCP) and an Open-Label Study protocol (severe PCP) was
       evaluated. A total of 940 patients intolerant of or unresponsive to
       trimethoprimsulfamethoxazole were enrolled from private practices,
       clinics, and institutional HIV treatment centers in the United States.
       Demographics data and the history and severity of PCP were collected at
       enrollment. The number of therapy days, adverse experiences, clinical
       response to therapy, and mortality were collected at day 21. Reporting
       of serious, unexpected adverse experiences attributable to therapy was
       required. Of the 760 (96%) patients with mild to moderate disease for
       whom follow-up observation was complete, 591 (78%) responded clinically
       to treatment, 177 patients (23%) discontinued treatment prematurely, and
       50 patients (7%) died. Of the 140 patients (95%) with severe PCP with
       follow-up data, 79 (56%) responded to treatment, 45 (32%) discontinued
       treatment early, and 53 patients (38%) died. Adverse events that
       resulted in temporary or permanent discontinuation of therapy included
       diarrhea, vomiting, elevated liver enzyme levels, nausea, and fever. No
       serious unexpected adverse events attributable to the drug were
       reported. The treatment IND mechanism enabled a large number of patients
       with acute PCP to be treated with this experimental therapy while the
       drug was under regulatory view.
 DE    Acute Disease  Administration, Oral  Adolescence  Adult  Aged
       Antifungal Agents/ADVERSE EFFECTS/*THERAPEUTIC USE  AIDS-Related
       Opportunistic Infections/*DRUG THERAPY  Child  Child, Preschool  Drugs,
       Investigational/ADVERSE EFFECTS/*THERAPEUTIC USE  Female  Follow-Up
       Studies  Human  HIV Seropositivity/COMPLICATIONS  Infant  Male  Middle
       Age  Naphthoquinones/ADVERSE EFFECTS/*THERAPEUTIC USE  Pneumonia,
       Pneumocystis carinii/*DRUG THERAPY  CLINICAL TRIAL  CONTROLLED CLINICAL
       TRIAL  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).