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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Adefovir; Adefovir dipivoxil

Criteria

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).