HIV InfectionsPhase 1DC-HIV04NCT03758625
Comparison of Dendritic Cell-Based Therapeutic Vaccine Strategies for HIV Functional Cure
A Phase 1 study testing a1DC + inactivated whole autologous HIV, a1DC + conserved HIV peptides and a1DC + no antigen in people with HIV Infections, run by Sharon Riddler at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- a1DC + inactivated whole autologous HIV, a1DC + conserved HIV peptides and a1DC + no antigen
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2019to 19 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Receiving continuous ART for at least 24 months (defined as no interruptions longer than 14 consecutive days) and with no changes in the components of the ART for at least 8 weeks prior to study entry. A change in formulation (for example tenofovir disaproxil fumarate to tenofovir alafenamide) will not be considered a change in ART.
- Screening CD4+ cell count ≥350cells/mm3 obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
- 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.
- NOTE: Unconfirmed plasma HIV-1 RNA > 50 copies/ml but <200 copies/mL is allowed if followed by a subsequent value < 50 copies/ml.
- 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.
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- Men and women age 18 to 70 years, inclusive.
- The following laboratory values obtained within 60 days prior to entry:
- Hemoglobin ≥10 g/dL Absolute neutrophil count (ANC) ≥1000/mm3 Platelet count ≥100,000/mm3 Creatinine ≤ 1.5x upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤2.5x ULN
- Ability and willingness of participant to provide informed consent.
- In the opinion of the investigator, no medical, mental health or other condition that precludes participation.
- For females of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or is using a point-of-care (POC)/ CLIA-waived test. Females of reproductive potential include women who have not been post-menopausal for at least 12 consecutive months, (i.e., who have had menses within the preceding 12 months) or women who have not undergone surgical sterilization (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation or salpingectomy). Self- report is acceptable documentation of menopause and sterilization.
- 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.
Who cannot join
- Currently breastfeeding or pregnant
- Known allergy/sensitivity or any hypersensitivity to components of study vaccine or their formulation.
- Known chronic inflammatory conditions such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune hepatitis, myositis, or myopathy.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serious medical illness that requires systemic treatment and/or hospitalization within 30 days prior to entry.
- Use of systemic immunomodulators (eg, interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry.
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- NOTE: Participants receiving stable physiologic doses of glucocorticoids, defined as the equivalent of prednisone ≤10 mg/day, will not be excluded. Stable physiologic glucocorticoid doses should not be discontinued for the duration of the study. In addition, participants receiving inhaled or topical corticosteroids, or topical imiquimod will not be excluded.
- Participation on any HIV immunotherapy or therapeutic vaccination trials within 6 months prior to study entry.
- History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
- NOTE: Persons with positive HCV Ab but negative plasma HCV RNA are allowed to participate. Sites must document negative HCV RNA within 24 weeks of study entry.
- History of positive HBsAg within 48 weeks prior to study entry.
- Treatment for hepatitis C within 6 months prior to study entry.
- Initiation of ART during acute HIV-1 infection (as determined by the site investigator by history and/or available medical records).
- Lack of adequate venous access that, in the opinion of the investigator, would interfere with study requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AIDS Clinical Trials Unit/The Ohio State University
Columbus, Ohio, 43210
HIV/AIDS Clinical Research Unit / University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Immunogenicity of a Therapeutic HIV Vaccine Composed of Autologous Dendritic Cells Loaded With Autologous Inactivated Whole Virus or Conserved Peptides in ART-treated HIV-infected Adults
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.
Read the detailed description
Despite the availability of strong medicines for HIV infection, there is no cure for the infection. The current anti-HIV drugs, used in combination, are effective in slowing the growth of the virus and delaying the progression of the infection. There is increasing information to suggest that a vigorous immune response (a strong response of the body to fight infection) to HIV may also result in improved control of the HIV infection. Such strong immune responses are found in a small number of HIV-infected individuals, but not in the majority.
Dendritic cells, or DCs, are a type of white blood cell that works together with other immune cells to fight infection. The DCs role is to bring substances foreign to the body, such as viruses including HIV or cancer cell proteins, to the body's immune system. Large numbers of DCs can be made from blood samples and administered back to the same person as an individualized vaccine. Vaccines made from DCs have been studied in HIV and numerous types of cancer.
The vaccines will be created by two different laboratory methods, standard or improved, using an individual's own DCs and either an individual's own inactive HIV that has been killed with heat or manmade HIV proteins called peptides. The peptides have not been studied for this use in humans, and these vaccines are not approved by the Food and Drug Administration (FDA) to prevent or treat HIV infection.
This study will be done in two steps. During Step 1 (Entry-Week 12), participants will have 4 study visits for tests, procedures and exams. At Week 4, participants will be randomized by chance into one of six study groups, like rolling dice. Four of the study groups will receive a DC-HIV vaccine while two of the study groups will receive a "control" vaccine with only DCs. Participants will have a 4:1 chance of receiving a DC-HIV study vaccine.
- Group 1: enhanced DC-HIV vaccine with inactive HIV
- Group 2: enhanced DC-HIV vaccine with HIV peptides
- Group 3: enhanced DCs only (control)
- Group 4: classic DC-HIV vaccine with inactive HIV
- Group 5: classic DC-HIV vaccine with HIV peptides
- Group 6: classic DCs only (control)
Each participant will receive 6 study vaccinations at 4-week intervals beginning at Week 12. Researchers will compare the results from participants who get the active study vaccines with results from participants who get the control vaccines. Participants, the researchers and the clinic staff will not know which vaccine participants are getting.
In Step 2 (Weeks 12 - 80), participants will have 18 study visits to receive the 6 study vaccinations and for tests to monitor health and safety and to see how the study vaccine affects the immune system and the virus.
- Conditions
- HIV Infections
- Being tested
- a1DC + inactivated whole autologous HIV, a1DC + conserved HIV peptides, a1DC + no antigen, pgDC + inactivated whole autologous HIV, pgDC + conserved HIV peptides
- Keywords
- dendritic cell, vaccine, immunogenicity, HIV, vaccination, immune system
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a1DC + inactivated whole autologous HIVBiological
Investigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with autologous -inactivated HIV
a1DC + conserved HIV peptidesBiological
Investigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with a conserved HIV gag and pol peptide pool
a1DC + no antigenBiological
Control vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) but without an antigen
pgDC + inactivated whole autologous HIVBiological
Investigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with autologous -inactivated HIV
pgDC + conserved HIV peptidesBiological
Investigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with a conserved HIV gag and pol peptide pool
pgDC + no antigenBiological
Control vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) but without an antigen
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | a1DC + inactivated whole autologous HIV vaccine given as six monthly doses of approximately 10e7 DC per dose Receives: Biological: a1DC + inactivated whole autologous HIV |
| ARM B | Experimental | a1DC + conserved HIV peptides vaccine given as six monthly doses of approximately 10e7 DC per dose Receives: Biological: a1DC + conserved HIV peptides |
| ARM C | Active comparator | a1DC + no antigen vaccine given as six monthly doses of approximately 10e7 DC per dose Receives: Biological: a1DC + no antigen |
| ARM D | Experimental | pgDC + inactivated whole autologous HIV vaccine given as six monthly doses of approximately 10e7 DC per dose Receives: Biological: pgDC + inactivated whole autologous HIV |
| ARM E | Experimental | pgDC + conserved HIV peptides vaccine given as six monthly doses of approximately 10e7 DC per dose Receives: Biological: pgDC + conserved HIV peptides |
| ARM F | Active comparator | pgDC + no antigen vaccine given as six monthly doses of approximately 10e7 DC per dose Receives: Biological: pgDC + no antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Occurrence of Grade ≥ 3 AE including signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the site investigator, blinded to treatment arm) at any time from the initial dose of DC vaccine product to end of study follow-up.
Measured: Step 2-Week 0 (overall Study Week 12) to overall Study Week 80
Efficacy of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART
Change in HIV-specific CD8 and T-cell immune response as measured by ELISPOT between the vaccine arms.
Measured: Baseline to Step 2-Week 22 (overall Study Week 34)
Secondary outcomes (6)
Relative efficacy of the DC-HIV vaccines in priming HIV-specific-CD8+ T cells
Change in the ability of the DC-HIV vaccines to inhibit autologous HIV in an ex vivo virus inhibition assay.
Measured: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on the level of persistent viremia in plasma
Change in plasma HIV-1 RNA viral load as measured by single copy assay (SCA)
Measured: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on HIV specific CD8 T-cell polyfunctional responses
Change in HIV specific CD8 T-cell polyfunctional responses as measured by intracellular cytokine staining using flow cytometry.
Measured: Baseline to Step 2-Week 22 (overall Study Week 34)
Assess the impact of DC-HIV vaccination on levels of cell-associated HIV-1 RNA and DNA
Changes in cell-associated HIV-1 RNA and DNA levels and assessment of the differences between the vaccine arms
Measured: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on the levels of immune activation
Changes in markers of cellular immune cell activation and assessment of the differences between the vaccine arms
Measured: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on the levels of systemic inflammation
Changes in soluble markers of systemic inflammation and assessment of the differences between the vaccine arms
Measured: Baseline to Step 2-Week 22 (overall Study Week 34)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start2 Jan 2019
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, multi-arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Riddler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sharon Riddler, University of Pittsburgh
- Investigators
- Sharon Riddler, MD, Study chair, University of PittsburghBernard Macatangay, MD, Study chair, University of PittsburghJohn Mellors, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758625
- Sponsor's protocol ID
- DAIDS-ES 38541
- Other IDs
- U01AI131285
- Acronym
- DC-HIV04
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2018
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability and Immunogenicity of a Therapeutic HIV Vaccine Composed of Autologous Dendritic Cells Loaded With Autologous Inactivated Whole Virus or Conserved Peptides in ART-treated HIV-infected Adults
- ClinicalTrials.gov ID
- NCT03758625
- Acronym / sponsor ID
- DC-HIV04 / DAIDS-ES 38541
- Conditions
- HIV Infections
- Keywords
- dendritic cell, vaccine, immunogenicity, HIV, vaccination, immune system
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sharon RiddlerUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite the availability of strong medicines for HIV infection, there is no cure for the infection. The current anti-HIV drugs, used in combination, are effective in slowing the growth of the virus and delaying the progression of the infection. There is increasing information to suggest that a vigorous immune response (a strong response of the body to fight infection) to HIV may also result in improved control of the HIV infection. Such strong immune responses are found in a small number of HIV-infected individuals, but not in the majority.
Dendritic cells, or DCs, are a type of white blood cell that works together with other immune cells to fight infection. The DCs role is to bring substances foreign to the body, such as viruses including HIV or cancer cell proteins, to the body's immune system. Large numbers of DCs can be made from blood samples and administered back to the same person as an individualized vaccine. Vaccines made from DCs have been studied in HIV and numerous types of cancer.
The vaccines will be created by two different laboratory methods, standard or improved, using an individual's own DCs and either an individual's own inactive HIV that has been killed with heat or manmade HIV proteins called peptides. The peptides have not been studied for this use in humans, and these vaccines are not approved by the Food and Drug Administration (FDA) to prevent or treat HIV infection.
This study will be done in two steps. During Step 1 (Entry-Week 12), participants will have 4 study visits for tests, procedures and exams. At Week 4, participants will be randomized by chance into one of six study groups, like rolling dice. Four of the study groups will receive a DC-HIV vaccine while two of the study groups will receive a "control" vaccine with only DCs. Participants will have a 4:1 chance of receiving a DC-HIV study vaccine.
- Group 1: enhanced DC-HIV vaccine with inactive HIV
- Group 2: enhanced DC-HIV vaccine with HIV peptides
- Group 3: enhanced DCs only (control)
- Group 4: classic DC-HIV vaccine with inactive HIV
- Group 5: classic DC-HIV vaccine with HIV peptides
- Group 6: classic DCs only (control)
Each participant will receive 6 study vaccinations at 4-week intervals beginning at Week 12. Researchers will compare the results from participants who get the active study vaccines with results from participants who get the control vaccines. Participants, the researchers and the clinic staff will not know which vaccine participants are getting.
In Step 2 (Weeks 12 - 80), participants will have 18 study visits to receive the 6 study vaccinations and for tests to monitor health and safety and to see how the study vaccine affects the immune system and the virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized, double-blind, multi-arm
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Biological: a1DC + inactivated whole autologous HIVa1DC + inactivated whole autologous HIV vaccine given as six monthly doses of approximately 10e7 DC per dose |
| ARM B | Experimental | Biological: a1DC + conserved HIV peptidesa1DC + conserved HIV peptides vaccine given as six monthly doses of approximately 10e7 DC per dose |
| ARM C | Active comparator | Biological: a1DC + no antigena1DC + no antigen vaccine given as six monthly doses of approximately 10e7 DC per dose |
| ARM D | Experimental | Biological: pgDC + inactivated whole autologous HIVpgDC + inactivated whole autologous HIV vaccine given as six monthly doses of approximately 10e7 DC per dose |
| ARM E | Experimental | Biological: pgDC + conserved HIV peptidespgDC + conserved HIV peptides vaccine given as six monthly doses of approximately 10e7 DC per dose |
| ARM F | Active comparator | Biological: pgDC + no antigenpgDC + no antigen vaccine given as six monthly doses of approximately 10e7 DC per dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Receiving continuous ART for at least 24 months (defined as no interruptions longer than 14 consecutive days) and with no changes in the components of the ART for at least 8 weeks prior to study entry. A change in formulation (for example tenofovir disaproxil fumarate to tenofovir alafenamide) will not be considered a change in ART.
- Screening CD4+ cell count ≥350cells/mm3 obtained within 60 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent.
- 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.
- NOTE: Unconfirmed plasma HIV-1 RNA > 50 copies/ml but <200 copies/mL is allowed if followed by a subsequent value < 50 copies/ml.
Key exclusion criteria (14 listed)
- Currently breastfeeding or pregnant
- Known allergy/sensitivity or any hypersensitivity to components of study vaccine or their formulation.
- Known chronic inflammatory conditions such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis), chronic pancreatitis, or autoimmune hepatitis, myositis, or myopathy.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serious medical illness that requires systemic treatment and/or hospitalization within 30 days prior to entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a1DC + inactivated whole autologous HIVInvestigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with autologous -inactivated HIV | Biological | ARM A |
| a1DC + conserved HIV peptidesInvestigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with a conserved HIV gag and pol peptide pool | Biological | ARM B |
| a1DC + no antigenControl vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) but without an antigen | Biological | ARM C |
| pgDC + inactivated whole autologous HIVInvestigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with autologous -inactivated HIV | Biological | ARM D |
| pgDC + conserved HIV peptidesInvestigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with a conserved HIV gag and pol peptide pool | Biological | ARM E |
| pgDC + no antigenControl vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) but without an antigen | Biological | ARM F |
Primary outcome
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
Time frame: Step 2-Week 0 (overall Study Week 12) to overall Study Week 80
Occurrence of Grade ≥ 3 AE including signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the site investigator, blinded to treatment arm) at any time from the initial dose of DC vaccine product to end of study follow-up.
Efficacy of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART
Time frame: Baseline to Step 2-Week 22 (overall Study Week 34)
Change in HIV-specific CD8 and T-cell immune response as measured by ELISPOT between the vaccine arms.
6 secondary outcomes
Relative efficacy of the DC-HIV vaccines in priming HIV-specific-CD8+ T cells
Time frame: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on the level of persistent viremia in plasma
Time frame: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on HIV specific CD8 T-cell polyfunctional responses
Time frame: Baseline to Step 2-Week 22 (overall Study Week 34)
Assess the impact of DC-HIV vaccination on levels of cell-associated HIV-1 RNA and DNA
Time frame: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on the levels of immune activation
Time frame: Baseline to Step 2-Week 22 (overall Study Week 34)
Effect of DC-HIV vaccination on the levels of systemic inflammation
Time frame: Baseline to Step 2-Week 22 (overall Study Week 34)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Riddler, MD study chair
University of Pittsburgh
Bernard Macatangay, MD study chair
University of Pittsburgh
John Mellors, MD study chair
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing a1DC + inactivated whole autologous HIV, a1DC + conserved HIV peptides and a1DC + no antigen in people with HIV Infections, run by Sharon Riddler at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Step 2-Week 0 (overall Study Week 12) to overall Study Week 80). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.