Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002220
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Multi-Center Open-Label Study of the Effect of Indinavir Efavirenz and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir
Status:
COMPLETED
Status Verified Date:
1999-06
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 compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor PI Effectiveness is measured by the number of patients who have a viral load level of HIV in the blood below 400 copiesml after 48 weeks of treatment
Detailed Description:
In this open-label nonrandomized study 120 HIV-infected patients are stratified into two groups failed nelfinavir vs protease inhibitor-naive All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine orally Plasma vRNA is measured every 4 weeks until Week 16 then every 8 weeks for the remainder of the 48-week study
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 |
|---|---|---|---|
| 075-00 | None | None | None |