Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002426
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy HAART in HIV-Positive Patients
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy HAART in HIV Infected Patients With HIV-1 RNA 50 and 400 CopiesMl
Status:
COMPLETED
Status Verified Date:
1999-12
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:
The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug adefovir dipivoxil ADV in combination with other anti-HIV drugs HAART to patients who have a viral load level of HIV in the blood between 50 and 400 copiesml
Detailed Description:
Patients are randomized to 1 of 2 arms in a 21 ratio Approximately 260 patients receive ADV and approximately 130 patients receive placebo Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16 24 and 48 Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigators discretion In both cases patients continue their study visits as per the original visit schedule Virologic failure is defined as 2 consecutive HIV-1 RNA measurements after baseline above 400 copiesml measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay drawn at least 14 days apart All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator
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-97-415 | None | None | None |