Combination Vaccination Before HIV Treatment Interruption

This study is currently recruiting participants.

Verified by Ottawa Health Research Institute, July 2007

First Received: September 13, 2005 Last Updated: November 14, 2007 History of Changes

Sponsors and Collaborators:	Ottawa Health Research Institute Canadian Institutes of Health Research (CIHR) Ontario HIV Treatment Network Canadian HIV Trials Network
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00212888

Purpose

The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.

Condition	Intervention	Phase
HIV Infections	Biological: Remune and ALVAC	Phase I Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Pilot Study to Determine the Impact of Therapeutic HIV Vaccination Followed by a Scheduled Interruption of Antiretroviral Therapy on HIV-Specific Immune Function and Virologic Rebound in Patients With Prolonged Viral Suppression

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

Time to detectable virus in the Remune plus ALVAC group and the placebo group (between group t-test)

Secondary Outcome Measures:

Time to detectable virus in the ALVAC alone group and the placebo group
Time to rebound of plasma HIV RNA level to 10,000 copies/ml
Viral set-point
Magnitude of viral rebound
HIV-specific immune function [ Time Frame: at week 48 ]

Estimated Enrollment:	60
Study Start Date:	April 2004
Estimated Study Completion Date:	April 2007

Detailed Description:

Volunteers will be randomly assigned to receive the vaccines or matching placebos before interrupting their antiretroviral therapy at week 24.

Dosage:

Remune(TM) 1 ml i.m.* at weeks 0, 12, and 20; ALVAC 1 ml i.m.* at weeks 8,12, 16, and 20.

i.m.: injected in a muscle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented HIV infection (by serology)
HIV RNA level below 50 copies/ml for at least two years
Receiving at least 2 antiretroviral agents including at least 1 protease inhibitor or 1 non-nucleoside reverse transcriptase inhibitor at time of screening
Have CD4 counts above 500 cells/ul
Have CD4/CD8 ratio above 0.5
Have never had a CD4 count below 250
No previous AIDS-defining opportunistic infection
No previous cancer chemotherapy or other system immunosuppressive therapy (excluding brief courses [<= 1 month] of prednisone or its equivalent)
Able to provide informed consent

Exclusion Criteria:

Hepatitis B surface antigen positive
Hepatitis C antibody positive
AST, ALT, ALP, creatinine, urea above three times the normal upper limit
Blood abnormalities (hemoglobin lower than 100, white blood cell count [WBC] lower than 1500 or platelets lower than 100)
Allergies to components of Remune™ or ALVAC
Contraindications to vaccine components
Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212888

Locations

Canada, Ontario
The Ottawa Hospital, General Campus	Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Jonathan B Angel, MD 613-737-8442 jangel@ottawahospital.on.ca
Contact: Nancy Lamoureux, RN 613-737-8209 nlamoureux@ohri.ca
Principal Investigator: Jonathan B Angel, MD
Canada, Quebec
Montreal Chest Institute	Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact: Jean-Pierre Routy, MD 514-843-2090 RoutyJP@muhchem.mcgill.ca
CHUM Hotel-Dieu	Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Cécile Tremblay, MD 514-890-8000 c.tremblay@umontreal.ca

Sponsors and Collaborators

Ottawa Health Research Institute

Canadian Institutes of Health Research (CIHR)

Ontario HIV Treatment Network

Canadian HIV Trials Network

Investigators

Principal Investigator:

Jonathan B Angel, MD

OHRI

More Information

No publications provided

Study ID Numbers:	2000456-01H, CTA file 9427-C1574-32C
Study First Received:	September 13, 2005
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00212888 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

HIV
Vaccination

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009