40 Participants Needed

HIV Vaccines for Human Immunodeficiency Virus Infection

(DC-HIV04 Trial)

Recruiting at 1 trial location
RW
SK
JF
Overseen ByJamie Fullerton, MPPM
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sharon Riddler
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will be done in people living with HIV to see if an investigational vaccine made from a person's own white blood cells is safe and tolerated. This study will also look at the body's immune response to the vaccine and evaluate four different methods of making the vaccine to see which method may result in better immune responses.

Who Is on the Research Team?

BM

Bernard Macatangay, MD

Principal Investigator

University of Pittsburgh

JM

John Mellors, MD

Principal Investigator

University of Pittsburgh

SR

Sharon Riddler, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults aged 18-70 with stable HIV infection, on continuous ART for at least 24 months, and undetectable viral load for over two years. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception if necessary, and have no history of certain chronic conditions or recent hospitalizations.

Inclusion Criteria

Creatinine ≤ 1.5x upper limit of normal (ULN)
Platelet count ≥100,000/mm3
All participants must agree not to participate in the conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the participant/partner must use at least one reliable form of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormone-based contraceptive), while receiving study treatment and for 12 weeks following the final study vaccine.
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Exclusion Criteria

I am on a low dose of steroids or use inhaled/topical steroids and will continue them during the study.
I started HIV treatment early after diagnosis.
Lack of adequate venous access that, in the opinion of the investigator, would interfere with study requirements.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Step 1

Participants undergo initial tests, procedures, and exams. Randomization into study groups occurs at Week 4.

12 weeks
4 visits (in-person)

Step 2

Participants receive 6 study vaccinations at 4-week intervals and are monitored for health, safety, and immune response.

68 weeks
18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • a1DC + conserved HIV peptides
  • a1DC + inactivated whole autologous HIV
  • a1DC + no antigen
  • pgDC + conserved HIV peptides
  • pgDC + inactivated whole autologous HIV
  • pgDC + no antigen
Trial Overview The trial is testing a personalized vaccine made from participants' white blood cells against HIV. It aims to see which of the four vaccine-making methods works best in terms of safety and immune response enhancement.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Active Control
Group I: ARM EExperimental Treatment1 Intervention
pgDC + conserved HIV peptides vaccine given as six monthly doses of approximately 10e7 DC per dose
Group II: ARM DExperimental Treatment1 Intervention
pgDC + inactivated whole autologous HIV vaccine given as six monthly doses of approximately 10e7 DC per dose
Group III: ARM BExperimental Treatment1 Intervention
a1DC + conserved HIV peptides vaccine given as six monthly doses of approximately 10e7 DC per dose
Group IV: ARM AExperimental Treatment1 Intervention
a1DC + inactivated whole autologous HIV vaccine given as six monthly doses of approximately 10e7 DC per dose
Group V: ARM CActive Control1 Intervention
a1DC + no antigen vaccine given as six monthly doses of approximately 10e7 DC per dose
Group VI: ARM FActive Control1 Intervention
pgDC + no antigen vaccine given as six monthly doses of approximately 10e7 DC per dose

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sharon Riddler

Lead Sponsor

Trials
3
Recruited
90+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+
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