Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004998
Status:
SUSPENDED
Last Update Posted:
2005-06-24
First Post:
2000-03-21
Brief Title:
Safety and Effectiveness of a New Anti-HIV Drug AG1549 in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Open-Label Study of AG1549 in Combination With Other Antiretroviral Agents 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 see if two different doses of AG1549 plus other anti-HIV drugs are safe and effective in 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 one of two doses of AG1549 plus Viracept nelfinavir plus Combivir zidovudinelamivudine Patients remain on their assigned therapy for 48 weeks with a follow-up visit at 28 to 35 days after the last dose of study medication Blood samples are taken regularly to quantify HIV-1 RNA CD4 and CD8 counts peripheral blood mononuclear cells PBMC AG1549 Viracept and M8 plasma concentrations Physical exams safety assessments and other tests are also done throughout the study On Day 8 and at the end of Week 48 pharmacokinetic samples are collected at 0 05 10 15 20 25 30 40 60 80 and 120 hours postdose At the end of Weeks 4 8 16 24 and 36 pharmacokinetic samples are taken 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 |
|---|---|---|---|
| AG1549-503 | None | None | None |