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 Sciences2 sites in 1 country36 target enrollmentStarted: August 31, 2001Last updated: June 24, 2005

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Gilead Sciences
Enrollment: 36
Locations: 2

Study Overview Study Design Eligibility Criteria Investigators Sites Records & Identifiers Similar Trials

Study 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.

Study Design

Study Type: Interventional
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 18 Years to 60 Years (Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Investigators

Sponsor

Gilead Sciences

Sponsor Class

Industry

Study Sites (2)

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