Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002161
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts 200mm3
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts 200mm3
Status:
COMPLETED
Status Verified Date:
1997-05
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 evaluate the anti-HIV activity safety and tolerance of adefovir dipivoxil bis-POM PMEA in combination with standard antiretroviral therapy for 48 weeks
Detailed Description:
Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks after which all patients will receive open-label drug for an additional 24 weeks Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks Patients are followed every 4 weeks during the first 24 weeks of study then every 8 weeks during the last 24 weeks
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-96-408 | None | None | None |