Clinical Trials Directory

A Phase I Randomized, Partially Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a Cytokine Enhanced HIV-1 Multi-Antigen (HIV MAG) pDNA Vaccine Delivered Intramuscularly Followed by in Vivo Electroporation (IM/EP) or Intramuscularly in HIV-1 Infected Adults Receiving ART

Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. This study will also test a new way of giving the vaccine called electroporation (EP).

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • biological : IL-12
  • biological : IL-12
  • biological : Profectus HIV MAG pDNA vaccine
  • biological : Profectus HIV MAG pDNA vaccine
  • other : Placebo
  • other : Placebo

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - 55 Years

Inclusion Criteria

- HIV-1 infected - Stable antiretroviral therapy (ART) for a minimum of 6 consecutive months prior to study entry and intention to remain on stable ART until study completion - CD4 T-cell count greater than or equal to 500 cells/mm3 (within 30 days prior to study entry) - At least two measurements of HIV-1 RNA levels less than or equal to 200 copies/mL (first measurement must be performed at least 6 months prior to study entry and second measurement must be performed between 6 months prior to study entry and at least 30 days prior to study entry) - Screening HIV-1 RNA less than 50 copies/mL (within 30 days prior to study entry) - Hepatitis B surface antigen negative (within 30 days prior to study entry) - Hepatitis C antibody negative or, if hepatitis C antibody positive, hepatitis C virus RNA negative (within 30 days prior to study entry) - Certain laboratory values obtained within 30 days prior to study entry; more information can be found in the protocol - Females of reproductive potential must have a negative urine pregnancy test within 3 days prior to study entry - All study participants participating in sexual activity that could lead to pregnancy must agree to use at least one of the following forms of birth control for at least 21 days prior to study entry until the final study visit: - Condoms (male or female) with or without a spermicidal agent - Diaphragm or cervical cap with spermicide - Intrauterine device (IUD) - Hormone-based contraceptive - Females who are not of reproductive potential are eligible without requiring the use of a contraceptive - Ability and willingness of subject to provide written informed consent - Collection of a pre-entry PBMC specimen for immunologic assays and entered into the Laboratory Data Management System (LDMS)

External Links

Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting

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