Study Evaluating Vaccine in Adults With HIV

Study Overview
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Brief Summary
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The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV. A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.

Official Title
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A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine Administered Alone or With Escalating Doses of IL-12 DNA or IL-15 DNA Molecular Adjuvants to HIV-1 Positive Adults Receiving Stable HAART.

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: HIV-1 gag DNA (formulated with bupivacaine)
* Biological: IL-15 DNA (formulated with bupivacaine)
* Biological: IL-12 DNA (formulated with bupivacaine)
* Biological: Sodium chloride injection USP (0.9%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be HIV positive. Receiving stable HAART for a minimum of 6 consecutive months immediately before screening. CD4 T-cell count greater than 350 mm cubed/mL at time of screening and no reported CD4 T-cell count less than 250 mm cubed/mL at any time before screening. Other Inclusions Apply Exclusion Criteria: Any chronic symptomatic infection other than HIV. History of diagnosed autoimmune disease (currently active or under control). Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening (documented, unblinded placebo recipients from previous clinical trials may participate without this time restriction). Other Exclusions Apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIV-1 gag DNA (formulated with bupivacaine)|nan|
|Biological: IL-15 DNA (formulated with bupivacaine)|nan|
|Biological: IL-12 DNA (formulated with bupivacaine)|nan|
|Biological: Sodium chloride injection USP (0.9%)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART |  |  | 
| intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-12 DNA following each vaccine dose (total of three doses) in individuals on stable HAART |  |  | 
| intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-15 DNA following each vaccine dose (total of three doses) in individuals on stable HAART |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Vaccine, Treatment Experienced