Combination Vaccination Before HIV Treatment Interruption

Phase 1

Completed

• Conditions: HIV Infections

• Registration Number: NCT00212888
• Lead Sponsor: Ottawa Hospital Research Institute

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.

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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2010-07
• Study Completion: 2010-11
• Results First Submitted: 2017-03-28
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-19
• Last Update Submitted: 2019-03-19
• Results First Posted: 2019-06-17
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group	Up to week 48

Secondary Outcome Measures

Name	Time	Method
Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml	Up to week 48
Viral Set-point	Up to week 48	Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.
Magnitude of Viral Rebound	Up to week 48	Magnitude of viral rebound is the amount of HIV viral load an infected person who was previously on ART and suppressed below clinical detection rebounds to following ART stoppage. This will typically be compared to the viral load before starting ART or Viral set-point discussed earlier.
HIV-specific Immune Function	at week 48
Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group	Up to week 48

Trial Locations

Locations (3)

The Ottawa Hospital, General Campus; 🇨🇦 Ottawa, Ontario, Canada

CHUM Hotel-Dieu; 🇨🇦 Montreal, Quebec, Canada

Montreal Chest Institute; 🇨🇦 Montreal, Quebec, Canada