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Clinical Trials/NCT00002346
NCT00002346
Completed
Phase 1

A Phase I/II Study of Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) and Placebo in HIV-Infected Patients

Gilead Sciences1 site in 1 country36 target enrollmentAugust 31, 2001
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ConditionsHIV Infections
DrugsAdefovir dipivoxil

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Gilead Sciences
Enrollment
36
Locations
1
Status
Completed
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.

Detailed Description

Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.

Registry
clinicaltrials.gov
Start Date
August 31, 2001
End Date
TBD
Last Updated
20 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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