Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002380
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
Sponsor:
Hoffmann-La Roche
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Pharmacokinetic and Safety Study of Saquinavir Soft Gelatin Capsules and Pediatric Pellet Formulations in Combination With Nucleoside Antiretroviral Agents With or Without Nelfinavir in HIV-Infected Infants and Children
Status:
COMPLETED
Status Verified Date:
1997-08
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:
To determine the pharmacokinetic properties tolerance and safety of 2 formulations of saquinavir given in combination with 2 nucleoside antiretroviral drugs part 1 or in combination with nelfinavir and nucleoside antiretroviral drugs part 2 in HIV-infected infants and children
Detailed Description:
This Phase III study will be conducted in 2 parts each lasting at least 24 weeks Pharmacokinetics and safety data for part 1 a treatment regimen containing saquinavir and nucleoside antiretrovirals will be collected for 8 weeks before proceeding to part 2 During the first 8 weeks pharmacokinetic data will be analyzed to allow dose adjustments for individual patients and to confirm the starting dose estimates for part 2 In addition safety data will be reviewed to ensure that saquinavir is well tolerated with nucleoside antiretrovirals before it is combined with a second protease inhibitor In part 2 saquinavir will be combined with nelfinavir a protease inhibitor recently approved for use in children The pharmacokinetics and safety profile of these drugs in combination will be determined
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 |
|---|---|---|---|
| NV 15445 | None | None | None |