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Cancer Vaccine

HIV Vaccines for Human Immunodeficiency Virus Infection (DC-HIV04 Trial)

Phase 1
Waitlist Available
Research Sponsored by Sharon Riddler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV-1 infection, documented by any FDA-approved assay. NOTE: The term 'licensed' refers to a US FDA approved kit, which is required for all investigational new drug (IND) studies.
Screening HIV-1 RNA levels <50 copies/mL using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent within 60 days prior to entry.
Must not have
Serious medical illness that requires systemic treatment and/or hospitalization within 30 days prior to entry.
Initiation of ART during acute HIV-1 infection (as determined by the site investigator by history and/or available medical records).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up step 2-week 0 (overall study week 12) to overall study week 80
Awards & highlights
No Placebo-Only Group

Summary

This trial will study an HIV vaccine made from a person's white blood cells. It will test safety, immune response, and compare four vaccine-making methods.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue or allergic responses to components of the vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am HIV positive, confirmed by an FDA-approved test.
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My recent HIV test shows less than 50 copies/mL.
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not been hospitalized or needed serious medical treatment in the last 30 days.
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I started HIV treatment early after diagnosis.
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I have a chronic inflammatory condition like rheumatoid arthritis or Crohn's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~step 2-week 0 (overall study week 12) to overall study week 80
This trial's timeline: 3 weeks for screening, Varies for treatment, and step 2-week 0 (overall study week 12) to overall study week 80 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART
Safety and tolerability of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART
Secondary study objectives
Assess the impact of DC-HIV vaccination on levels of cell-associated HIV-1 RNA and DNA
Effect of DC-HIV vaccination on HIV specific CD8 T-cell polyfunctional responses
Effect of DC-HIV vaccination on the level of persistent viremia in plasma
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Sharon RiddlerLead Sponsor
2 Previous Clinical Trials
51 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,327 Previous Clinical Trials
5,365,949 Total Patients Enrolled
Bernard Macatangay, MDStudy ChairUniversity of Pittsburgh
John Mellors, MDStudy ChairUniversity of Pittsburgh
2 Previous Clinical Trials
59 Total Patients Enrolled
Sharon Riddler, MDStudy Chair - University of Pittsburgh
Medical College Of Wisconsin (Medical School)
University Of Pittsburgh Medical Center (Residency)
2 Previous Clinical Trials
883 Total Patients Enrolled

Media Library

a1DC + conserved HIV peptides (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03758625 — Phase 1
Human Immunodeficiency Virus Infection Research Study Groups: ARM A, ARM B, ARM C, ARM D, ARM E, ARM F
Human Immunodeficiency Virus Infection Clinical Trial 2023: a1DC + conserved HIV peptides Highlights & Side Effects. Trial Name: NCT03758625 — Phase 1
a1DC + conserved HIV peptides (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03758625 — Phase 1
~1 spots leftby Mar 2025
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