Expired Study
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Baltimore, Maryland 21205


Purpose:

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.


Study summary:

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


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).


NCT ID:

NCT00002128


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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