Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002219
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Open-Label Multi-Center Study of the Pharmacokinetics Safety Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil ADF and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients
Status:
UNKNOWN
Status Verified Date:
1999-11
Last Known Status:
ACTIVE_NOT_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 it is safe and effective to give adefovir a new anti-HIV drug plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications
Detailed Description:
During the first phase of the study Days 1-6 the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patients reverse transcriptase inhibitor RTI regimen The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks ADF pharmacokinetics are measured on Days 1 2 and 7 on a subset of 18 patients peak and trough samples are collected on Day 28
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 |
|---|---|---|---|
| GS-97-418 | None | None | None |