Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002213
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy With 1592U89 141W94 and DMP 266 in HIV-1 Infected Subjects With Detectable HIV-1 Plasma RNA Despite Treatment With a Protease Inhibitor Containing Regimen
Status:
COMPLETED
Status Verified Date:
1998-03
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:
The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir ritonavir saquinavir or nelfinavir after at least 20 weeks of protease inhibitor treatment This study also examines how long this combination therapy is effective before patients develop resistance to it
Detailed Description:
This is a multicenter open-label study A total of 80 patients are treated on this study and include
At least 30 patients with a viral burden of 500 - 40000 copiesml At least 30 patients with a viral burden greater than 40000 copiesml At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors NRTIs
All patients receive self-administered combination antiretroviral therapy for 48 weeks as follows
1592U89 plus 141W94 plus DMP 266
At least 30 patients with a viral burden of 500 - 40000 copiesml At least 30 patients with a viral burden greater than 40000 copiesml At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors NRTIs
All patients receive self-administered combination antiretroviral therapy for 48 weeks as follows
1592U89 plus 141W94 plus DMP 266
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 |
|---|---|---|---|
| CNAA2007 | None | None | None |