Combination Vaccination Before HIV Treatment Interruption

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: Remune and ALVAC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group |  | Up to week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group |  | Up to week 48 | 
| Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml |  | Up to week 48 | 
| 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 | 
| 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 | 
| HIV-specific Immune Function |  | at week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Vaccination