Document 0626
 DOCN  M9610626
 TI    Assessment of antiretroviral therapy by plasma viral load testing:
       standard and ICD HIV-1 p24 antigen and viral RNA (QC-PCR) assays
       compared.
 DT    9601
 AU    Kappes JC; Saag MS; Shaw GM; Hahn BH; Chopra P; Chen S; Emini EA;
       McFarland R; Yang LC; Piatak M Jr; et al; Department of Medicine,
       University of Alabama at Birmingham, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Oct 1;10(2):139-49.
       Unique Identifier : AIDSLINE MED/96007275
 AB    To assess the utility of quantitative competitive-polymerase chain
       reaction (QC-PCR) measurements of plasma human immunodeficiency virus
       type 1 (HIV-1) RNA and other viral load markers for assessment of
       antiretroviral therapy, we used archived cryopreserved specimens from a
       randomized controlled clinical trial of 135 patients (CD4+ T cell count
       < or = 500/mm3), comparing zidovudine (500 mg/day) versus the
       nonnucleoside reverse transcriptase inhibitor L-697, 661 (50, 300, or
       1,000 mg daily). We evaluated treatment-associated changes in plasma
       viral load by standard and immune complex-dissociated (ICD) HIV-1 p24
       antigen assays, and, in a representative subset of patients (n = 46), by
       QC-PCR determination of virion-associated HIV-1 RNA. At baseline, HIV-1
       RNA was quantifiable by QC-PCR in all patients tested (100%), whereas
       standard and ICD HIV-1 p24 antigen tests were positive (> or = 30 pg/ml)
       in 42% and 56%, respectively. All viral load parameters showed
       significant decreases from baseline within 1 week of initiation of
       zidovudine, as measured by standard p24 antigen assay, ICD p24 assay,
       and QC-PCR. At 1 week, patients treated with either 300 or 1,000 mg/day
       of L-697,661 showed significant decreases from baseline in plasma
       standard and ICD p24 antigen and QC-PCR-determined HIV-1 RNA levels.
       Whereas viral load decreases seen with zidovudine were sustained for the
       duration of treatment, plasma viral markers often returned to
       pretreatment levels despite ongoing L-697,661 treatment, with evidence
       of the emergence of drug-resistant virus. Whereas standard p24, ICD p24,
       and viral RNA levels changed similarly in response to treatment, the
       superior sensitivity and available dynamic range of plasma viral RNA
       assays like QC-PCR analysis provide an advantage for clinical monitoring
       of plasma viral load, allowing tracking of treatment-related changes
       even in patients with earlier stage disease and lower levels of viral
       load.
 DE    Antiviral Agents/*THERAPEUTIC USE  Benzoxazoles/THERAPEUTIC USE
       Biological Markers  Comparative Study  CD4 Lymphocyte Count
       Double-Blind Method  Human  HIV Core Protein p24/*ANALYSIS  HIV
       Infections/DRUG THERAPY/*VIROLOGY  HIV-1/DRUG
       EFFECTS/GENETICS/IMMUNOLOGY/*ISOLATION & PURIF  Immunoassay  Polymerase
       Chain Reaction  Prospective Studies  Pyridones/THERAPEUTIC USE  Reverse
       Transcriptase Inhibitors/THERAPEUTIC USE  RNA, Viral/*ANALYSIS  Support,
       Non-U.S. Gov't  Support, U.S. Gov't, Non-P.H.S.  Support, U.S. Gov't,
       P.H.S.  Viremia/DRUG THERAPY/*VIROLOGY  Zidovudine/THERAPEUTIC USE
       CLINICAL TRIAL  JOURNAL ARTICLE  RANDOMIZED CONTROLLED TRIAL

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