Tenofovir Disoproxil Fumarate

10/17/01

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Table of Contents

Tenofovir Disoproxil Fumarate

Preclinical Toxicology

Study 901Design

Study 901Baseline HIV Characteristics

Study 901HIV RNA

Study 901Mean Change from Baseline in HIV-1 RNA

Study 902Design

Study 902Design

Study 902 Baseline HIV Characteristics

Study 902Patient Disposition

Study 902Patient Disposition

Study 902Primary Efficacy Endpoint

Study 902Mean Change from Baseline in HIV-1 RNA

Study 902Grade 3/4 Adverse Eventsa

Study 907Design

Study 907Baseline Characteristics

Study 907Baseline HIV Characteristics

Study 907Virology Substudy

Study 907Patient Disposition

Study 907 Primary Efficacy Endpoint

Study 907Mean Change from Baseline in HIV-1 RNA

Study 907Subgroup Analyses

Study 907Secondary Efficacy Endpoints

Study 907Grade 3/4 Adverse Eventsa

Study 907Grade 3/4 Laboratory Abnormalitiesa

Renal and Bone Parameters

Studies 902 and 907Integrated Safety Analysis

Studies 902 and 907Integrated Safety Analysis

Studies 902 & 907Consecutive Visits with Grade 1 Creatinine

Studies 902 & 907 Consecutive Visits Serum Phosphate ɚ.0 mg/dL

Studies 902 and 907Bone Fracture Summary

Efficacy Summary

Study 907Virology Substudy

VirologyThymidine Analog Mutations (TAMs)

Studies 902 & 907Response by Number of Baseline TAMs

Studies 902 & 907Response by Baseline Phenotypic Susceptibility

Study 907Virology Substudy

Virology Summary

Clinical Conclusions

Indication: Study Design

Indication: Supportive Findings

Author: Glenn Itano