Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:

Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002128
• Other study ID #: 232A
• Secondary ID: GS-93-401
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1994
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.

Description:

Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).

• Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).

Patients must have:

• Documented HIV infection or diagnosis of AIDS.

• Life expectancy of at least 3 months.

Prior Medication:

Allowed:

• Prior AZT, ddI, or ddC.

• Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy.

• Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.

• Gastrointestinal malabsorption syndrome or inability to receive oral medication.

Concurrent Medication:

Excluded:

• Diuretics.

• Amphotericin B.

• Aminoglycoside antibiotics.

• Parenteral antibiotics.

• Other nephrotoxic agents.

• Other investigational agents.

• Non-steroidal anti-inflammatory drugs.

• Aspirin.

Prior Medication:

Excluded within 2 weeks prior to study entry:

• Diuretics.

• Amphotericin B.

• Aminoglycoside antibiotics.

• Parenteral antibiotics.

• Other nephrotoxic agents.

• Other investigational agents.

Excluded within 3 days prior to study entry:

• Non-steroidal anti-inflammatory drugs.

• Aspirin. Active substance abuse (including alcohol or drug abuse).

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Adefovir dipivoxil

Locations

Country	Name	City	State
United States	Johns Hopkins Univ	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cundy KC, Barditch-Crovo P, Walker RE, Collier AC, Ebeling D, Toole J, Jaffe HS. Clinical pharmacokinetics of adefovir in human immunodeficiency virus type 1-infected patients. Antimicrob Agents Chemother. 1995 Nov;39(11):2401-5. — View Citation