       Document 0593
 DOCN  M9610593
 TI    Viral phenotype and genotype as markers in clinical trials.
 DT    9601
 AU    Katzenstein DA; Center for AIDS Research, Stanford University Medical
       Center, CA; 94305, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S25-34.
       Unique Identifier : AIDSLINE MED/96033809
 AB    Treatment of AIDS and HIV infection is increasingly dependent on the use
       of surrogate markers to assess the efficacy of drug and biologic
       therapies in individual patients and in the clinical trials. Recent
       developments in laboratory techniques have resulted in new assays to
       measure circulating viral RNA in HIV-infected individuals, standardized
       methods to assess genotypic changes in virus associated with drug
       resistance and biologic assays for syncytia-inducing phenotype, a viral
       characteristic associated with rapid clinical progression. Studies from
       our laboratory have examined the relationship between surrogate markers
       of drug efficacy, CD4 cell changes, quantitative HIV plasma RNA and cell
       dilution cultures, genotypic changes associated with drug resistance and
       the syncytia-inducing phenotype. The results of these studies suggest
       that drug-resistance genotype and syncytia-inducing phenotype are
       independent factors that contribute to disease progression in patients
       receiving zidovudine. The design of studies of drugs and biologics for
       the treatment of HIV should include assessment of genotypic and
       phenotypic characteristics of HIV in addition to CD4 cell numbers and
       virus load.
 DE    Antiviral Agents/PHARMACOLOGY/THERAPEUTIC USE  Biological Markers
       Clinical Trials/*METHODS  CD4 Lymphocyte Count  Disease Progression
       Drug Resistance, Microbial/GENETICS  DNA, Viral/BLOOD  Genotype  Giant
       Cells  Human  HIV/DRUG EFFECTS/GENETICS/*PHYSIOLOGY  HIV
       Infections/THERAPY/*VIROLOGY  Phenotype  RNA, Viral/BLOOD  JOURNAL
       ARTICLE  REVIEW  REVIEW, TUTORIAL

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

