Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002346
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Study of Safety Tolerance Pharmacokinetics and Anti-HIV Activity of 9-2-BispivaloyloxymethylPhosphonylmethoxyethylAdenine Bis-POM PMEA and Placebo in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
1995-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GS-93-402 | None | None | None |