NCT00212888

Combination Vaccination Before HIV Treatment Interruption

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-04-01
• Primary completion: 2010-07-01
• Completion: 2010-11-01
• First posted: 2005-09-21
• Last updated: 2019-06-17
• Results posted: 2019-06-17

Locations

3 sites across 1 country: Canada