Document 0583
 DOCN  M9610583
 TI    Inter-Company Collaboration Combination Trials. Clinical Trial
       Subcommittee of the Inter-Company Collaboration for AIDS Drug
       Development.
 DT    9601
 AU    Soo W; Nauss-Karol C; Elkins M; Rooney J; Barry DW; Hoffmann-La Roche
       Inc., Nutley, NJ 07110-1199, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S92-6.
       Unique Identifier : AIDSLINE MED/96033818
 AB    The Inter-Company Collaboration for AIDS Drug Development (ICC)
       represents a collaborative effort among member companies to facilitate
       the conduct of clinical trials on AIDS drugs. One of the goals of the
       ICC is to expedite the development of combination antiretroviral therapy
       through data and compound sharing. Recently, the ICC formed a consensus
       master protocol to evaluate rapidly the safety and efficacy of
       triple-drug combinations of antiretroviral therapy for treatment of
       HIV-infected patients. This concept builds upon historical work with
       combination chemotherapy that resulted in treatments to successfully
       control chronic immunosuppressive, infectious or malignant diseases,
       such as tuberculosis, leprosy, childhood acute lymphoblastic leukemia,
       and Hodgkin's lymphoma. Because of limitations on potency and the
       continuing emergence of drug resistance seen with use of currently
       available antiretroviral agents in monotherapy and two-drug combination
       regimens, triple-combination regimens should represent a more promising
       approach to maximize antiviral activity, maintain long-term efficacy,
       and reduce the incidence of drug resistance. The ICC master protocol is
       a randomized, controlled, double-blind study with a treatment duration
       of 52 weeks. Patients eligible to enroll in this study must have
       documented HIV infection, with CD4 counts between 200 and 500 cells/mm3,
       and no history of antiretroviral therapy. The first four triple-drug
       combinations will be evaluated in two trials. These regimens have been
       selected based on encouraging data from laboratory and clinical studies.
       Each ICC trial will consist of three arms, with 75 patients per arm.
       Protocol ICC 001 will include AZT + zalcitabine (ddC) + saquinavir, AZT
       + ddC + nevirapine, and AZT + ddC as the control arm.(ABSTRACT TRUNCATED
       AT 250 WORDS)
 DE    Antiviral Agents/*THERAPEUTIC USE  *Clinical Protocols  Cohort Studies
       Double-Blind Method  Drug Therapy, Combination  Human  HIV
       Infections/*DRUG THERAPY  *Randomized Controlled Trials  JOURNAL ARTICLE

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