Combination Vaccination Before HIV Treatment Interruption

Ottawa Hospital Research Institute

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV Infections

Treatments

Biological: Remune and ALVAC

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT00212888

2000456-01H

CTA file 9427-C1574-32C

Details and patient eligibility

About

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.

Full 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

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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