The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00002346

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Adefovir dipivoxil	Phase 1

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

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication:

Allowed:

Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.

Patients must have:

HIV seropositivity.
CD4 count >= 100 cells/mm3.
p24 antigen (immune-complex dissociated) >= 50 pg/ml.
Life expectancy of at least 6 months.

Prior Medication:

Allowed:

Prior prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active, serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
Malignancy other than cutaneous Kaposi's sarcoma.
Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
Gastrointestinal malabsorption syndrome.
Inability to take oral medication.