Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000901
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Open-Labeled 96-Week Study to Investigate the Safety Pharmacokinetics and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2021-10
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 anti-HIV drug combination of indinavir IDV plus stavudine d4T plus lamivudine 3TC to HIV-infected children IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach
Detailed Description:
In this multicenter open-label study patients receive a combined drug regimen of indinavir stavudine and lamivudine over 48 weeks Patients are evaluated at Weeks 0 2 4 every 4 weeks until Week 24 and every 8 weeks thereafter until study completion AS PER AMENDMENT 42799 The study has been extended for an additional 48 weeks for a total of 96 weeks
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 |
|---|---|---|---|
| 11351 | REGISTRY | DAIDS ES | None |