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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Adefovir dipivoxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002128

232A

GS-93-401

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).