Viewing Study NCT00005758



Ignite Creation Date: 2024-05-05 @ 11:21 AM
Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005758
Status: COMPLETED
Last Update Posted: 2021-11-01
First Post: 2000-05-23

Brief Title: Effectiveness of Giving an HIV Vaccine Remune to HIV-Positive Patients Receiving an Anti-HIV Drug Combination
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: A Phase III Randomized Double-Blind Placebo-Controlled Evaluation of the Effect of Immunization With an HIV Immunogen on the Time to Virologic Relapse in Individuals Receiving Potent Suppressive Antiretroviral Therapies
Status: COMPLETED
Status Verified Date: 2021-10
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 effects of the HIV vaccine Remune on viral load level of HIV in the blood and on the way the immune system responds to HIV This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below 50 copiesml compared to those who have a viral load from 50 to 500 copiesml This study is currently being redesigned and the purpose may be revised Treatment with anti-HIV drugs does not always keep HIV viral load undetectable so low that it cannot be measured This study originally added an HIV vaccine called Remune to treat patients Remune was thought to reduce viral load and improve immune responses However new information suggests that Remune may not be as effective as was first believed The study has been changed to follow people already in the study and to let people enroll only if they participate in the substudy The substudy will look at the effect of another HIV vaccine vCP1452 on the immune response and how it works in combination with Remune Information about the safety of these vaccines in HIV-positive patients will be gathered
Detailed Description: Studies have shown that inactivated gp120-depleted whole virus immunogen Remune boosts immune responses to HIV One response lymphocyte proliferative response LPR to p24 is correlated with a low viral load in some patients with long-term non-progression of disease This study examines whether administering Remune vaccine may generate new immune responses or boost existing responses to keep the level of virus in the blood low for a longer period of time than antiretroviral therapy alone AS PER AMENDMENT 72000 In a recent study using Remune comparison of virologic failure and time to virologic failure between Remune and adjuvant placebo arms revealed no differences between the 2 arms of the study Results of this study suggest that the hypothesis in A5057 that recipients of Remune would have only 50 percent of the number of virologic relapses as occur in the control arm is no longer plausible in its current design This protocol is being redesigned A substudy adds the HIV canarypox vaccine vCP1452 in patients in the parent study and evaluates whether canarypox vaccine can augment the immune responses of Remune

Patients will add either Remune Arm A or the placebo Incomplete Freunds Adjuvant Arm B to their antiretroviral therapy They will be stratified to 1 of the following 4 groups

1 Patients suppressed with 3 or more antiretroviral drugs for 15 months or longer with an HIV-1 RNA below 50 copiesml and who may have substituted 1 antiretroviral medication during that time
2 Patients suppressed with 3 or more antiretroviral drugs who have not taken antiretroviral medications for 15 months or longer with an HIV-1 RNA below 50 copiesml and who may have substituted 1 antiretroviral medication during that time AS PER AMENDMENT 72000 This stratum includes patients who have taken their current antiretroviral therapy for less than 15 months prior to screening viral load measurement If these patients changed from prior antiretroviral regimens during the 15 months prior to screening they must have changed at least 2 antiretroviral drugs during this time
3 Patients suppressed with 3 or more antiretroviral drugs and whose HIV-1 RNA is 50 copiesml or higher
4 Patients suppressed with 2 antiretroviral drugs Injections of either Remune or IFA are given at Day 1 and once every 12 weeks for 96 weeks Patients remain at the clinic for observation for 30 minutes following the first and second injections If a patients HIV viral level rises above a certain level the patient and hisher health care provider may decide to change antiretroviral drugs to try and lower it Injections will be suspended until the lower level is achieved then resumed on the regular 12-week schedule If the decision is not to change therapy or the viral load does not decrease to under 500 copiesml within 3 to 4 months injections may still be received as long as the HIV RNA level is below 5000 copiesml Blood samples are collected prior to every injection to determine CD4CD8 counts and viral load to assay for viral presence in peripheral blood mononuclear cells and to store for future studies Pregnancy tests for women of reproductive potential physical exams and medical histories are done prior to every immunization

An immunological substudy will randomize 80 of the eligible volunteers from the study cohort to additionally receive ALVAC vCP1452 or placebo ALVAC with equal probability Arm A will receive ALVAC vCP1452 Arm B will be administered placebo

AS PER AMENDMENT 72000 The study is closed to accrual except for patients who enroll into A5058s until the protocol can be redesigned Patients enrolled under Version 10 continue to be followed every 12 weeks plus or minus 14 days until the end of the study Patients should continue taking the same potent antiretroviral treatment that they were taking at study entry until reaching the primary endpoint of first virologic relapse

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
10673 REGISTRY None None
A5058s None None None
ACTG A5057 None None None
AACTG A5057 Registry Identifier DAIDS ES Registry Number None