Tenofovir Disoproxil Fumarate

10/17/01


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Table of Contents

Tenofovir Disoproxil Fumarate

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Pharmacology

Preclinical Toxicology

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Overview

Study 901 Design

Study 901 Baseline HIV Characteristics

Study 901 HIV RNA

Study 901 Mean Change from Baseline in HIV-1 RNA

Study 902 Design

Study 902 Design

Study 902 Baseline HIV Characteristics

Study 902 Patient Disposition

Study 902 Patient Disposition

Study 902 Primary Efficacy Endpoint

Study 902 Mean Change from Baseline in HIV-1 RNA

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Study 902 Grade 3/4 Adverse Eventsa

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Study 907 Design

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Study 907 Baseline Characteristics

Study 907 Baseline HIV Characteristics

Study 907 Virology Substudy

Study 907 Patient Disposition

Study 907 Primary Efficacy Endpoint

Study 907 Mean Change from Baseline in HIV-1 RNA

Study 907 Subgroup Analyses

Study 907 Secondary Efficacy Endpoints

Study 907 Grade 3/4 Adverse Eventsa

Study 907 Grade 3/4 Laboratory Abnormalitiesa

Renal and Bone Parameters

Studies 902 and 907 Integrated Safety Analysis

Studies 902 and 907 Integrated Safety Analysis

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Studies 902 & 907 Consecutive Visits with Grade 1 Creatinine

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

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Studies 902 and 907 Bone Fracture Summary

Safety Summary

Efficacy Summary

Study 907 Virology Substudy

Virology Thymidine Analog Mutations (TAMs)

Studies 902 & 907 Response by Number of Baseline TAMs

Studies 902 & 907 Response by Baseline Phenotypic Susceptibility

Study 907 Virology Substudy

Virology Summary

Clinical Conclusions

Indication

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Indication: Study Design

Indication: Supportive Findings

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Author: Glenn Itano