Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
NCT ID: NCT00002128
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Adefovir dipivoxil
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
60 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Locations
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Johns Hopkins Univ
Baltimore, Maryland, United States
Countries
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References
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Cundy KC, Barditch-Crovo P, Walker RE, Collier AC, Ebeling D, Toole J, Jaffe HS. Clinical pharmacokinetics of adefovir in human immunodeficiency virus type 1-infected patients. Antimicrob Agents Chemother. 1995 Nov;39(11):2401-5. doi: 10.1128/AAC.39.11.2401.
Other Identifiers
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GS-93-401
Identifier Type: -
Identifier Source: secondary_id
232A
Identifier Type: -
Identifier Source: org_study_id