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

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.

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

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