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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
Plasma HIV-1 RNA levels < 50 copies/ml for at least 24 months prior to study entry using a FDA-approved assay performed by any laboratory that has a CLIA certification or its equivalent. Participants must have at least one documented HIV-1 RNA less than 50 copies/ml >24 months prior to study entry and at least one HIV-1 RNA less than 50 copies/ml within 12 months prior to study entry. All available HIV-1 RNA measurements must be < 50 copies/ml during the 24 months prior to study entry except as allowed by the following note.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up step 2-week 0 (overall study week 12) to overall study week 80
Awards & highlights

DC-HIV04 Trial 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.Check my eligibility
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.See study design
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.

DC-HIV04 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My HIV-1 levels have been below 50 copies/ml for the last 24 months.
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I am HIV positive, confirmed by an FDA-approved test.
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My recent CD4+ cell count is 350 or higher.
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My recent HIV test shows less than 50 copies/mL.
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I've been on the same HIV treatment for at least 8 weeks without a break longer than 14 days.
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I am between 18 and 70 years old.

DC-HIV04 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

DC-HIV04 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
3,268 Previous Clinical Trials
5,481,092 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have joined this experiment?

"Affirmative, the clinicaltrials.gov database reveals that this research is currently enrolling patients. It was publicized on November 30th 2018 and underwent its last revision on June 22nd 2022. Forty individuals will be needed from two separate trial sites to complete the study."

Answered by AI

Are there still openings accessible to volunteers in this scientific trial?

"According to current records on clinicaltrials.gov, this research endeavor is actively recruiting participants. This trial was initially made public on the 30th of November 2018 and underwent its most recent revisionon the 22nd of June 2022."

Answered by AI

What prospective outcomes are researchers hoping to attain from this trial?

"The primary aim of this clinical trial, spanning a period from Step 2-Week 0 (overall Study Week 12) to overall Study Week 80, is determining the efficacy of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART. Secondary objectives include assessing the effect of these vaccinations on persistent viremia levels in plasma with single copy assay measurements, gauging their influence over polyfunctional responses by CD8 T cells as measured through intracellular cytokine staining via flow cytometry, and evaluating changes in systemic inflammation indicators"

Answered by AI

Has the Food and Drug Administration approved a1DC + inactivated whole autologous HIV for use?

"Our team at Power has assigned a1DC + inactivated whole autologous HIV a rating of 1, as this is still an early-stage trial with limited data regarding its effectiveness and safety."

Answered by AI

Does this study accept participants who are 70 years of age or older?

"This trial is recruiting patients who are between the ages of consent and retirement."

Answered by AI
~5 spots leftby Mar 2025