Combination Vaccination Before HIV Treatment Interruption

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212888
• Other study ID #: 2000456-01H
• Secondary ID: CTA file 9427-C1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2004
• Est. completion date: November 2010

Study information

• Verified date: March 2019
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Canada	CHUM Hotel-Dieu	Montreal	Quebec
Canada	Montreal Chest Institute	Montreal	Quebec
Canada	The Ottawa Hospital, General Campus	Ottawa	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR), CIHR Canadian HIV Trials Network, Ontario HIV Treatment Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group		Up to week 48
Secondary	Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group		Up to week 48
Secondary	Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml		Up to week 48
Secondary	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.	Up to week 48
Secondary	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.	Up to week 48
Secondary	HIV-specific Immune Function		at week 48