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A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated With Anti-HIV Drugs

Phase 1
Completed
Conditions
HIV Infections
Registration Number
NCT00002206
Lead Sponsor
Gilead Sciences
Brief Summary

The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV medicine. This study also examines how the body processes adefovir dipivoxil.

Detailed Description

This a double-blind, placebo-controlled, randomized Phase I/II study of the safety, tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected patients naive to antiretroviral therapy. Patients are randomized to receive a single daily dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Anderson Clinical Research

🇺🇸

Philadelphia, Pennsylvania, United States

Johns Hopkins Univ Clinical Pharmacology

🇺🇸

Baltimore, Maryland, United States

Anderson Clinical Research / Inc

🇺🇸

Pittsburgh, Pennsylvania, United States

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