Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002128
- Run by
- Gilead Sciences
- People needed
- 15
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins Univ — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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