NCT00212888

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

June 17, 2019

Completed
Last Updated

June 17, 2019

Status Verified

March 1, 2019

Enrollment Period

6.3 years

First QC Date

September 13, 2005

Results QC Date

March 28, 2017

Last Update Submit

March 19, 2019

Conditions

HIV Infections

Keywords

HIVVaccination

Outcome Measures

Primary Outcomes (1)

  • Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group

    Up to week 48

Secondary Outcomes (5)

  • Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group

    Up to week 48

  • Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml

    Up to week 48

  • Viral Set-point

    Up to week 48

  • Magnitude of Viral Rebound

    Up to week 48

  • HIV-specific Immune Function

    at week 48

Interventions

Remune and ALVACBIOLOGICAL

* Group 1) Remune™ (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20); * Group 2) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC (1 ml i.m.) at weeks 8, 12, 16 and 20; or * Group 3) Remune™ placebo (1ml i.m.) at weeks 0, 12 and 20 and ALVAC placebo (1 ml i.m.) at weeks 8, 12, 16 and 20.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

CHUM Hotel-Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (1)

  • Angel JB, Routy JP, Tremblay C, Ayers D, Woods R, Singer J, Bernard N, Kovacs C, Smaill F, Gurunathan S, Sekaly RP. A randomized controlled trial of HIV therapeutic vaccination using ALVAC with or without Remune. AIDS. 2011 Mar 27;25(6):731-9. doi: 10.1097/QAD.0b013e328344cea5.

    PMID: 21330911DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

remuneALVAC vaccine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Dr. Jonathan B Angel
Organization
OHRI
JANGEL@toh.ca
613-737-8442

Study Officials

  • Jonathan B Angel, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2004

Primary Completion

July 1, 2010

Study Completion

November 1, 2010

Last Updated

June 17, 2019

Results First Posted

June 17, 2019

Record last verified: 2019-03

Locations

CA(3)