Clinical trial NCT00212888: Combination Vaccination Before HIV Treatment Interruption
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV
Vaccination
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ontario HIV Treatment Network
name: CIHR Canadian HIV Trials Network
First posted: 2005-09-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group
timeFrame: Up to week 48
Secondary outcomes:
measure: Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group
timeFrame: Up to week 48
measure: Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml
timeFrame: Up to week 48
measure: Viral Set-point
timeFrame: Up to week 48
measure: Magnitude of Viral Rebound
timeFrame: Up to week 48
measure: HIV-specific Immune Function
timeFrame: at week 48
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
city: Montreal
country: Canada
facility: CHUM Hotel-Dieu
state: Quebec
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
Study officials:
affiliation: OHRI
name: Jonathan B Angel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.