Table of Contents
Resistance Collaborative Group Re-Analysis of Studies and Review of Ongoing Prospective Studies
Outline
HIV Resistance Collaborative Group Clinical Validation Subcommittee
Goals of Clinical Validation Subcommittee
Outline
HIV Resistance Collaborative Group Clinical Validation Subcommittee Workshop April 21-22, 1999
Clinical Validation Subcommittee Workshop April 21-22, 1999
Outline
Development of Standardized Data Analysis Plan (DAP)
Presentation of Data Analysis Plan by Victor DeGruttola
Outline
DAP Mutation Table
Nucleoside Reverse Transcriptase Inhibitors
Nucleotide Reverse Transcriptase Inhibitors
Protease Inhibitors
Calculation of Genotypic Sensitivity Score
Calculation of Phenotypic Sensitivity Score
Outline
Selection of Studies for Re-Analysis
PPT Slide
PPT Slide
Outline
Composite Data Presentations
Meta-Analysis from Surrogate Marker Working Group
Baseline HIV-1 RNA (Odds Ratio per 1.0 log10 Increase) Unadjusted - Retrospective Studies - Dropouts as Failures
Baseline HIV-1 RNA (Odds Ratio per 1.0 log10 Increase) Adjusted for Genotypic Sensitivity Score and New Drug Covariates
Baseline Genotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Unadjusted - Retrospective Studies - Dropouts as Failures
Baseline Genotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA and New Drug Covariates
Baseline # of NRTI Mutations (Odds Ratio per 1 additional) Adjusted for Other Classes in Regimen
Baseline # of NRTI Mutations (Odds Ratio per 1 additional) Adjusted for Baseline HIV RNA, New Drug Covariates and Other Classes
Baseline # of PI Mutations (Odds Ratio per 1 additional) Adjusted for Other Classes in Regimen
Baseline # of PI Mutations (Odds Ratio per 1 additional) Adjusted for Baseline HIV RNA, New Drug Covariates and Other Classes
4-FR Phenotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA, New Drug Covariates
10-FR Phenotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA, New Drug Covariates
Re-Analysis of Prospective Studies:VIRADAPT and GART
Post-Meeting Correction Baseline HIV-1 RNA (Odds Ratio per 1.0 log10 Increase) Adjusted for Genotypic Sensitivity Score, New Drug Covariates Prospective Studies - Dropouts as Failures
Baseline Genotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA, New Drug Covariates Prospective Studies – Dropouts as failures
Outline
Presentations by M. Para, M. Ait-Khaled, V. Miller
Outline
Ongoing Prospective Trials
VIRA3001
VIRA3001 Study Design
Patient Population
HIV-1 RNA Response Modified ITT (Observed Data)
HIV-1 RNA Response Modified ITT (LOCF)
Outline
Summary of Key Points
MELLORS END
BACKUP SLIDES
4-FR PI Phenotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA, New Drug Covariates and Other Classes
10-FR NRTI Phenotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA, New Drug Covariates, Other Classes
10-FR PI Phenotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA, New Drug Covariates, and Other Classes
Number of New Drugs in Regimen (Odds Ratio per Additional New Drug) Retrospective Studies - Dropouts as Failure
Baseline # of NRTI Mutations (Odds Ratio per 1 additional) Adjusted for Baseline HIV RNA, New Drug Covariates and Other Classes Prospective Studies - Dropouts as Failure
Baseline # of PI Mutations (Odds Ratio per 1 additional) Adjusted for Baseline HIV RNA, New Drug Covariates and Other Classes
4-FR NRTI Phenotypic Sensitivity Score (Odds Ratio per 1.0 Unit Increase) Adjusted for Baseline HIV RNA, New Drug Covariates, and Other Classes
Potent New Drug (Odds Ratio for Change from No to Yes) All Studies - Dropouts as Failures
Number of New Drugs in Regimen (Odds Ratio per Additional New Drug) Prospective Studies - Dropouts as Failure
Planned Analyses*
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