Resistance Collaborative Group Re-Analysis of Studies and Review of Ongoing Prospective Studies

7/25/00


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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*

Author: Jeff Booker, VisCom Inc.