The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients
Phase 1
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00002346
- Lead Sponsor
- Gilead Sciences
- Brief Summary
To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.
- Detailed Description
Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of bis-POM PMEA (adefovir dipivoxil) in inhibiting HIV reverse transcriptase and DNA polymerase gamma?
How does the safety profile of bis-POM PMEA compare to standard-of-care nucleoside reverse transcriptase inhibitors in HIV patients?
Which biomarkers correlate with virologic response to bis-POM PMEA in treatment-experienced HIV-infected individuals?
What are the potential drug-drug interactions of bis-POM PMEA with protease inhibitors or integrase inhibitors in HIV therapy?
How does bis-POM PMEA's pharmacokinetic profile influence dosing strategies for HIV treatment-resistant mutations?
Trial Locations
- Locations (1)
Johns Hopkins Univ
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Univ🇺🇸Baltimore, Maryland, United States