Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017992
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-06-23
Brief Title:
Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
Sponsor:
Triangle Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
RECRUITING
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 emtricitabine is safe in children infected with HIV and to determine the best dose
Detailed Description:
Children are placed into 1 of 4 treatment groups based on age Group 1 3 months to 24 months Group 2 25 months to 6 years Group 3 7 years to 12 years Group 4 13 years to 17 years They receive baseline evaluations Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavirritonavir Antiretroviral-experienced patients replace lamivudine with emtricitabine Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48 Safety is evaluated using adverse events which are reviewed at every clinic visit Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits After the Week 48 study evaluations are completed individual patients may continue to receive study medication as provided by the sponsor until commercially available if certain criteria are met
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 |
|---|---|---|---|
| FTC-203 | None | None | None |