Combination Vaccination Before HIV Treatment Interruption

NCT ID: NCT00212888

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2010-11-30

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

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

Remune and ALVAC

• 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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ontario HIV Treatment Network

NETWORK

Sponsor Role: collaborator

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan B Angel, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Locations

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

CHUM Hotel-Dieu

Montreal, Quebec, Canada

Montreal Chest Institute

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 21330911 (View on PubMed)

Other Identifiers

CTA file 9427-C1574-32C

Identifier Type: -

Identifier Source: secondary_id

2000456-01H

Identifier Type: -

Identifier Source: org_study_id