Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002164
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase I Study of Safety Tolerability and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase I Study of Safety Tolerability and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
Status:
COMPLETED
Status Verified Date:
1999-05
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 evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants 0 to 13 years of age An evaluation of the relative bioavailability of the pediatric powder formulation vs a standard tablet formulation in older children 7 to 13 years of age will also be conducted
Detailed Description:
This is a study of the safety tolerability and pharmacokinetics of a Viracept pediatric powder formulation with milk or formula First a single dose will be administered After the patient population is divided into 4 groups by age an optimal dose will be determined for each group This optimal dose will be given 3 times a day for a 6 week primary observation period plus an optional 6 month extension
NOTE During the single dose portion of this study patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy During multiple dose administration of Viracept antiretroviral therapy will be intensified by either adding or modifying therapy Antiretroviral therapies will be limited to those currently licensed including zidovudine lamivudine stavudine didanosine or zalcitabine
NOTE During the single dose portion of this study patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy During multiple dose administration of Viracept antiretroviral therapy will be intensified by either adding or modifying therapy Antiretroviral therapies will be limited to those currently licensed including zidovudine lamivudine stavudine didanosine or zalcitabine
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 |
|---|---|---|---|
| AG 1343-524 | None | None | None |