Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
Phase 1
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00002128
- Lead Sponsor
- Gilead Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins Univ
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Univ🇺🇸Baltimore, Maryland, United States