Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001758
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Continued Antiretroviral Therapy With Abacavir Amprenavir and Efavirenz
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Continued Salvage Anti-Retroviral Therapy With Abacavir Amprenavir and Efavirenz
Status:
COMPLETED
Status Verified Date:
2003-08
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:
This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcomes multi-center study on combination therapy with abacavir amprenavir and efavirenz A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89 141W94 and DMP 266 Sustiva in HIV-1 Infected Subjects with Detectable greater than 400 CopiesmL HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen
HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study Participants will be followed every 3 months with a general health evaluation and laboratory tests This is a NIH study and information will not be provided to Glaxo Wellcome
HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study Participants will be followed every 3 months with a general health evaluation and laboratory tests This is a NIH study and information will not be provided to Glaxo Wellcome
Detailed Description:
In this open-label single-arm study HIV-1 infected patients who had at study entry a viral burden of at least 500 copiesmL despite 20 weeks of treatment with a protease inhibitor receive combination therapy with three antiretroviral agents that were investigational at the start of study but have since been approved abacavir amprenavir and efavirenz At the end of 16 weeks the addition of other antiretroviral agents to the study regimen was permitted This was originally a multi-center study but it has been closed at all other sites It remains open at the NIH to continue to provide therapy to subjects who have received benefit as determined by a decline in viral load from baseline Safety and viral load data continue to be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-I-0031 | None | None | None |