Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002391
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Zidovudine Plus Lamivudine Used With and Without 1592U89 in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Double-Blind Randomized Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89Zidovudine ZDVLamivudine 3TC Versus the Combination of Zidovudine ZDVLamivudine 3TC in HIV-1 Therapy-Experienced Pediatric Patients
Status:
COMPLETED
Status Verified Date:
1998-11
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 compare the safety tolerance durability of the viral load response and the antiviral activity of the 1592U89zidovudineZDVlamivudine 3TC regimen vs ZDV3TC regimen To determine the clinical efficacy of the two regimens as measured survival disease progression weight growth velocity and neuropsychological or neurological changes To assess the development of viral resistance and relative pharmacokinetics associated with each regimen
Detailed Description:
Patients are randomized to receive blinded treatment with ZDV3TC alone or in combination with 1592U89 orally for 16 weeks If after the 16-week period certain criteria are met patients may have the option to switch to open-label treatment for the remainder of the study period
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 |
|---|---|---|---|
| CNAA3006 | None | None | None |