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

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

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Adefovir dipivoxil


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adefovir dipivoxil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents