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HIV Disease - Healing Genes
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HIV Disease

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Therapeutic Vaccination in Treated HIV Disease

Safety, Immunogenicty and Anti-Reservoir Activity of an Electroporation-Administered HIV DNA Vaccine Encoding GAG, POL and ENV Proteins With IL-12 Plasmid in HIV-Infected Adults on Antriretroviral Therapy


Phase 1/2

DESCRIPTION:

Doctors at two California research centers seek patients with human immunodeficiency virus trial a therapeutic DNA vaccine. This vaccine consists of 2 loops of selected DNA meant to 1) stimulate the body’s immune cells to specifically target HIV antigens and 2) produce cell messengers (interleukins) that promote the immune system to fight HIV . The body’s cells uses the genes to produce proteins that prompt the body to attack HIV.

Study participants will receive intramuscular injections 4 times over 12 weeks, along with a therapy that causes the muscle cells to better absorb the vaccine. One group will receive a placebo and 2 other groups will receive the vaccine therapy but with minute differences between them. Follow up will last at least 64 weeks.


PATIENT MUST:

  • Be 18 years to 65 years of age
  • Not be pregnant or breastfeeding
  • Be HIV-positive, confirmed through specific lab tests
  • Meet lab assessment requirements for overall health status
  • Be willing to utilize contraception during the period of the study

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Intramuscular injection of the therapy or placebo, with CELLECTRA™-5PSP electric muscle stimulation to enhance absorption of the vaccine.
  3. Repeat of step (2) at 4 weeks, 8 weeks, and 12 weeks.
  4. Follow up with lab and physical assessments for up to 64 weeks.

LOCATIONS & CONTACTS:

The study will take place at the University of California, Los Angeles, (Map), and Zuckerberg San Francisco General Hospital (ZSFG) (Map).

Contacts

Kara Chew, MD  |  310-825-0796  |  [email protected]

Judith Currier, MD  |  (310) 206-3474  |  [email protected]

Steven G Deeks, MD  |  415-206-3103  |  [email protected]

 

 

SPONSORS

Steven Deeks

National Institute of Allergy and Infectious Diseases (NIAID)

University of California, Los Angeles

Inovio Pharmaceuticals

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03606213

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