Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005002
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-03-21
Brief Title:
Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine Remune
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Double-Blind Adjuvant-Controlled Multicenter Study to Compare the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy HAART Plus Remune Versus HAART Plus Incomplete Freunds Adjuvant IFA in Antiretroviral-Naive Patients Infected With Human Immunodeficiency Virus Type 1 HIV-1
Status:
UNKNOWN
Status Verified Date:
2001-08
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 effective to add an HIV vaccine Remune to the anti-HIV drug combination of Combivir zidovudine plus lamivudine and nelfinavir
Detailed Description:
All patients begin HAART at study entry Day 1 Patients with a plasma HIV-1 RNA level less than or equal to 2000 copiesml at Week 8 are randomized to receive Remune or Incomplete Freunds Adjuvant IFA at Week 9 Patients who do not achieve a plasma HIV-1 RNA level of less than or equal to 2000 copiesml at Week 8 are not randomized and are terminated from the study These patients are eligible to receive funding for up to a 3-month supply of nelfinavir Viracept and Combivir Randomized patients receive Remune or IFA at Week 9 and approximately every 12 weeks thereafter until study completion when the last patient reaches Week 48 Patients are considered virologic failures if they 1 fail to achieve a virologic response by Week 48 or 2 after achieving a virologic response have a virologic relapse Regardless of their previous response status patients whose plasma HIV-1 RNA level increases to greater than 2000 copiesml while they are receiving protocol-specified HAART are eligible to receive salvage therapy and continue to receive Remune or IFA until study completion Study visits occur at screening Day 1 Weeks 4 8 9 12 and then every 4 weeks thereafter until the last patient reaches Week 48 Patients who complete this study are eligible to participate in a rollover study
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 |
|---|---|---|---|
| AG1661-202 | None | None | None |