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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.
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 belowSelect...
I am HIV positive, confirmed by an FDA-approved test.
Select...
My recent HIV test shows less than 50 copies/mL.
Select...
I am between 18 and 70 years old.
DC-HIV04 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ step 2-week 0 (overall study week 12) to overall study week 80
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~step 2-week 0 (overall study week 12) to overall study week 80
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 moreDC-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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive, confirmed by an FDA-approved test.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.I haven't taken any immune system drugs, chemotherapy, or experimental treatments in the last 60 days.I have been treated for hepatitis C within the last 6 months.My HIV-1 levels have been below 50 copies/ml for the last 24 months.My recent CD4+ cell count is 350 or higher.My recent HIV test shows less than 50 copies/mL.I've been on the same HIV treatment for at least 8 weeks without a break longer than 14 days.I have not been hospitalized or needed serious medical treatment in the last 30 days.You have participated in any HIV immunotherapy or therapeutic vaccination trials within the past 6 months.I have a chronic inflammatory condition like rheumatoid arthritis or Crohn's disease.I am between 18 and 70 years old.I have had a positive test for hepatitis C in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: ARM A
- Group 2: ARM B
- Group 3: ARM C
- Group 4: ARM D
- Group 5: ARM E
- Group 6: ARM F
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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