Combination Vaccination Before HIV Treatment Interruption

Ottawa Hospital Research Institute52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

HIV Infections

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

CHUM Hotel-Dieu

Montreal, Quebec, Canada

Montreal Chest Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: Up to week 48

Secondary Outcomes

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

Time frame: Up to week 48

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

Time frame: Up to week 48

Viral Set-point

Viral set-point is the viral load (HIV RNA) that the body settles at within a few weeks to months after infection with HIV.

Time frame: Up to week 48

Magnitude of Viral Rebound

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.

Time frame: Up to week 48

HIV-specific Immune Function

Time frame: at week 48

Data from ClinicalTrials.gov

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