Viewing Study NCT00005001



Ignite Creation Date: 2024-05-05 @ 11:22 AM
Last Modification Date: 2024-10-26 @ 9:04 AM
Study NCT ID: NCT00005001
Status: COMPLETED
Last Update Posted: 2005-06-24
First Post: 2000-03-21

Brief Title: Safety and 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 Pilot Phase II Double-Blind Study to Assess the Virologic Effect of Remune Versus Incomplete Freunds Adjuvant IFA in Patients Who Are Infected With Human Immunodeficiency Virus Type I HIV-1 Have a Plasma HIV-1 RNA Level Less Than 50 CopiesMl Are Receiving Highly Active Antiretroviral Therapy HAART and Who Subsequently Discontinue Their HAART Regimen
Status: COMPLETED
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 giving HIV-positive patients an HIV vaccine plus anti-HIV drugs can help lower HIV levels in the blood viral load
Detailed Description: At the time of study entry all patients are receiving a HAART regimen consisting of three drugs from at least two classes of antiretroviral drugs Upon entering the study patients receive Remune or IFA at Weeks 0 12 and 24 Patients remain on study for 40 weeks Patients who have received three injections of Remune or IFA and whose plasma HIV-1 RNA level is less than 50 copiesml at Week 26 discontinue HAART at Week 28 If the patient has a plasma HIV-1 RNA level at or above 50 copiesml at Week 26 heshe must have a measurement below 50 copiesml at Week 27 to proceed with HAART discontinuation at Week 28 If by Week 27 the patient does not have a plasma HIV-1 RNA level below 50 copiesml the patient does not discontinue HAART but remains on study and has study visits at Weeks 34 and 40 Patients who discontinue HAART have their plasma HIV-1 RNA levels measured on the day HAART is discontinued and at Days 3 5 7 10 14 21 28 35 and 42 after discontinuation Patients with a plasma HIV-1 RNA level of at least 5000 copiesml at Week 34 restart HAART at that time Patients whose plasma HIV-1 RNA level reaches greater than or equal to 100000 copiesml on two occasions before Week 34 have the option of restarting HAART immediately Patients whose plasma HIV-1 RNA level is less than 5000 copiesml at Week 34 do not restart HAART unless their level increases to at least 5000 copiesml Patients who discontinue HAART are monitored intensively for the duration of the study Patients have 27 visits if they stay on study until completion at Week 40

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
AG1661-201 None None None