Skip to main content
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems
  • Log in
  • My alerts
  • My Cart

Main menu

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About AAC
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • AAC Podcast
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
  • ASM
    • Antimicrobial Agents and Chemotherapy
    • Applied and Environmental Microbiology
    • Clinical Microbiology Reviews
    • Clinical and Vaccine Immunology
    • EcoSal Plus
    • Eukaryotic Cell
    • Infection and Immunity
    • Journal of Bacteriology
    • Journal of Clinical Microbiology
    • Journal of Microbiology & Biology Education
    • Journal of Virology
    • mBio
    • Microbiology and Molecular Biology Reviews
    • Microbiology Resource Announcements
    • Microbiology Spectrum
    • Molecular and Cellular Biology
    • mSphere
    • mSystems

User menu

  • Log in
  • My alerts
  • My Cart

Search

  • Advanced search
Antimicrobial Agents and Chemotherapy
publisher-logosite-logo

Advanced Search

  • Home
  • Articles
    • Current Issue
    • Accepted Manuscripts
    • COVID-19 Special Collection
    • Archive
    • Minireviews
  • For Authors
    • Submit a Manuscript
    • Scope
    • Editorial Policy
    • Submission, Review, & Publication Processes
    • Organization and Format
    • Errata, Author Corrections, Retractions
    • Illustrations and Tables
    • Nomenclature
    • Abbreviations and Conventions
    • Publication Fees
    • Ethics Resources and Policies
  • About the Journal
    • About AAC
    • Editor in Chief
    • Editorial Board
    • For Reviewers
    • For the Media
    • For Librarians
    • For Advertisers
    • Alerts
    • AAC Podcast
    • RSS
    • FAQ
  • Subscribe
    • Members
    • Institutions
Antiviral Agents

Efficacy of Zidovudine Compared to Stavudine, Both in Combination with Lamivudine and Indinavir, in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine, Stavudine, or Protease Inhibitors (Novavir Trial)

Véronique Joly, Philippe Flandre, Vincent Meiffredy, Françoise Brun-Vezinet, Jean-Albert Gastaut, Cécile Goujard, Gérard Remy, Diane Descamps, Annick Ruffault, Agnès Certain, Jean-Pierre Aboulker, Patrick Yeni for the Novavir Study Group
Véronique Joly
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: veronique.joly@bch.ap-hop-paris.fr
Philippe Flandre
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Vincent Meiffredy
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Françoise Brun-Vezinet
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jean-Albert Gastaut
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Cécile Goujard
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gérard Remy
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Diane Descamps
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Annick Ruffault
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Agnès Certain
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jean-Pierre Aboulker
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Patrick Yeni for the Novavir Study Group
Agence Française de Recherche sur le SIDA, Paris, France
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
DOI: 10.1128/AAC.46.6.1906-1913.2002
  • Article
  • Figures & Data
  • Info & Metrics
  • PDF
Loading

Article Figures & Data

Figures

  • Tables
  • FIG. 1.
    • Open in new tab
    • Download powerpoint
    FIG. 1.

    Kaplan-Meier estimates of the proportion of patients who did not reach the primary study endpoint (viral load of >5,000 copies/ml).

  • FIG. 2.
    • Open in new tab
    • Download powerpoint
    FIG. 2.

    Proportion of patients with serum HIV RNA levels of less than 500 copies/ml. Bars are 95% confidence intervals.

  • FIG. 3.
    • Open in new tab
    • Download powerpoint
    FIG. 3.

    Changes from baseline in the CD4 cell count during the 80 weeks of the study. Median values are shown. Bars are 25th and 75th percentiles. IQR, interquartile range.

Tables

  • Figures
  • TABLE 1.

    Baseline characteristics of patients

    CharacteristicValue for treatment armValue for total (n = 170)
    d4T-3TC-IDV (n = 85)AZT-3TC-IDV (n = 85)
    Sex, no. (%) male68 (80)67 (79)135 (79)
    Age, yr
        Median363737
        25%-75%32-4233-4733-44
    Prior nRTI
        Median duration     (mo)19.618.919.5
        25%-75%12-37.313-38.312-37.9
        No. (%) of patients     exposed to:
            AZT-ddI49 (58)40 (47)89 (52)
            AZT-ddC29 (34)35 (41)64 (38)
            AZT-ddC and         AZT-ddI5 (6)8 (9)13 (8)
    CDCa status, no. (%)
        CDC-A41 (48)39 (46)80 (47)
        CDC-B33 (39)39 (46)72 (42)
        CDC-C11 (13)7 (8)18 (11)
    CD4 cells/mm3
        Median291292291
        25%-75%216-370225-368221-368
    HIV RNA level, log10     copies/ml
        Median4.424.334.36
        25%-75%4.07-4.684.1-4.644.08-4.66
    • ↵ a CDC, Centers for Disease Control and Prevention.

  • TABLE 2.

    Subject disposition

    Reason subjects discontinued study drugsNo. of subjects (%)
    d4T-3TC-IDVAZT-3TC-IDV
    Before wk 8015 (18)24 (28)
        Lost to follow-up1 (1)1 (1)
        Death2 (2)0
        Adverse events7 (8)11 (13)
        Subject request2 (2)3 (4)
        Virological failure1 (1)6 (7)
        Physician decision01 (1)
        Other reason or unknown2 (2)2 (2)
    During the extended follow-up9 (16)13 (22)
        Lost to follow-up01 (2)
        Death1 (2)0
        Adverse events4 (7)0
        Subject request04 (7)
        Virological failure00
        Physician decision3 (5)2 (3)
        Other reason or unknown1 (2)6 (10)
  • TABLE 3.

    Number (percent) of patients with HIV-1 RNA levels of <50 copies/ml

    WkNo. (%) of patients
    d4T armAZT armTotal
    824 (32)19 (23)43 (28)
    1658 (75)57 (71)115 (73)
    2458 (77)59 (75)117 (76)
  • TABLE 4.

    Multivariate relative risk for predicting virological failure

    VariableRelative risk (95% CIa)P value
    Plasma HIV RNA level
        <50 versus >50 copies/ml at wk 160.32 (0.13-0.77)0.011
        <50 versus >50 copies/ml at wk 240.25 (0.09-0.70)0.008
        Decrease from baseline to wk 24 in     log copies/ml0.47 (0.32-0.70)<0.001
    Presence of the T215Y/F mutation0.39 (0.18-0.83)0.015
    • ↵ a CI, confidence interval.

  • TABLE 5.

    Grade 3 or 4 laboratory toxicities according to treatment group

    Type of toxicityNo. of events (no. of patients)
    d4T armAZT arm
    Total bilirubin6 (1)1 (1)
    ASATa1 (1)4 (2)
    ALATb3 (3)3 (3)
    Serum glucosec2 (1)4 (4)
    Triglyceridesc14 (9)3 (3)
    Serum amylase1 (1)2 (1)
        Total no.27 (16)17 (14)
    • ↵ a ASAT, aspartate aminotransferase.

    • ↵ b ALAT, alanine aminotransferase.

    • ↵ c Tests were obtained when patients were in a nonfasted state.

PreviousNext
Back to top
Download PDF
Citation Tools
Efficacy of Zidovudine Compared to Stavudine, Both in Combination with Lamivudine and Indinavir, in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine, Stavudine, or Protease Inhibitors (Novavir Trial)
Véronique Joly, Philippe Flandre, Vincent Meiffredy, Françoise Brun-Vezinet, Jean-Albert Gastaut, Cécile Goujard, Gérard Remy, Diane Descamps, Annick Ruffault, Agnès Certain, Jean-Pierre Aboulker, Patrick Yeni for the Novavir Study Group
Antimicrobial Agents and Chemotherapy Jun 2002, 46 (6) 1906-1913; DOI: 10.1128/AAC.46.6.1906-1913.2002

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Print

Alerts
Sign In to Email Alerts with your Email Address
Email

Thank you for sharing this Antimicrobial Agents and Chemotherapy article.

NOTE: We request your email address only to inform the recipient that it was you who recommended this article, and that it is not junk mail. We do not retain these email addresses.

Enter multiple addresses on separate lines or separate them with commas.
Efficacy of Zidovudine Compared to Stavudine, Both in Combination with Lamivudine and Indinavir, in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine, Stavudine, or Protease Inhibitors (Novavir Tri…
(Your Name) has forwarded a page to you from Antimicrobial Agents and Chemotherapy
(Your Name) thought you would be interested in this article in Antimicrobial Agents and Chemotherapy.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Share
Efficacy of Zidovudine Compared to Stavudine, Both in Combination with Lamivudine and Indinavir, in Human Immunodeficiency Virus-Infected Nucleoside-Experienced Patients with No Prior Exposure to Lamivudine, Stavudine, or Protease Inhibitors (Novavir Trial)
Véronique Joly, Philippe Flandre, Vincent Meiffredy, Françoise Brun-Vezinet, Jean-Albert Gastaut, Cécile Goujard, Gérard Remy, Diane Descamps, Annick Ruffault, Agnès Certain, Jean-Pierre Aboulker, Patrick Yeni for the Novavir Study Group
Antimicrobial Agents and Chemotherapy Jun 2002, 46 (6) 1906-1913; DOI: 10.1128/AAC.46.6.1906-1913.2002
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Top
  • Article
    • ABSTRACT
    • MATERIALS AND METHODS
    • RESULTS
    • DISCUSSION
    • APPENDIX
    • ACKNOWLEDGMENTS
    • FOOTNOTES
    • REFERENCES
  • Figures & Data
  • Info & Metrics
  • PDF

KEYWORDS

Anti-HIV Agents
HIV infections
HIV Protease Inhibitors
HIV-1
Indinavir
Lamivudine
Reverse Transcriptase Inhibitors
stavudine
zidovudine

Related Articles

Cited By...

About

  • About AAC
  • Editor in Chief
  • Editorial Board
  • Policies
  • For Reviewers
  • For the Media
  • For Librarians
  • For Advertisers
  • Alerts
  • AAC Podcast
  • RSS
  • FAQ
  • Permissions
  • Journal Announcements

Authors

  • ASM Author Center
  • Submit a Manuscript
  • Article Types
  • Ethics
  • Contact Us

Follow #AACJournal

@ASMicrobiology

       

ASM Journals

ASM journals are the most prominent publications in the field, delivering up-to-date and authoritative coverage of both basic and clinical microbiology.

About ASM | Contact Us | Press Room

 

ASM is a member of

Scientific Society Publisher Alliance

 

American Society for Microbiology
1752 N St. NW
Washington, DC 20036
Phone: (202) 737-3600

Copyright © 2021 American Society for Microbiology | Privacy Policy | Website feedback

Print ISSN: 0066-4804; Online ISSN: 1098-6596