Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004999
Status:
SUSPENDED
Last Update Posted:
2005-06-24
First Post:
2000-03-21
Brief Title:
Effectiveness of a New Anti-HIV Drug AG1549 Plus Viracept Nelfinavir Plus Combivir ZidovudineLamivudine in HIV-Infected Patients
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of AG1549 in Combination With Viracept Nelfinavir Mesylate and Combivir Zidovudine Lamivudine in Treatment-Naive HIV-Infected Patients
Status:
SUSPENDED
Status Verified Date:
2001-03
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 look at the effectiveness of giving a new anti-HIV drug AG1549 plus Viracept nelfinavir plus Combivir a tablet containing zidovudine plus lamivudine to HIV-infected patients who are not taking anti-HIV drugs
Detailed Description:
Note As of 2282001 due to toxicity studies and concerns for safety sites were notified that they need to discontinue patients from the capravirineplacebo arms and continue patients with their background therapies or switch patients to new therapies as deemed appropriate by the investigators Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit Blood samples are taken regularly to quantify plasma HIV-1 RNA CD4 and CD8 counts and peripheral blood mononuclear cells PBMC Physical exams safety assessments and other tests are also done throughout the study A blood sample is taken at baseline pre-dose for a pharmacokinetics assessment On Day 8 and at the end of Weeks 4 8 16 24 36 and 48 pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose
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 |
|---|---|---|---|
| AG1549-504 | None | None | None |