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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002128

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

Brief 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.

Detailed description

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

Interventions

DRUGAdefovir dipivoxil

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026