HIV InfectionsPhase 1/2HIVACARNCT03619278
Evaluating a Combination of Immune-based Therapies to Achieve a Remission of HIV Infection
A Phase 1/2 study testing HIVACAR in people with HIV Infections, run by Judit Pich.
Trial summary
A phase I/IIa, multinational, multicentric (IDIBAPS, IRSICAIXA, AARHUS, VUB, APHP), randomised, balanced by centre (to include participants from the 4 arms), open-label, controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIVACAR
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 15 Jul 2021
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between ≥ 18 to <60 years of age
- Voluntarily signed informed consent
- Male, or female with negative pregnancy test prior to enrolment
- Proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA before cART)
- Must be on stable treatment with cART for at least 18 months (cART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents; periods of mono/dual antiretroviral therapy if not first time therapy and confirmed viral suppression during these periods of mono/dual therapy are permitted)
- Nadir CD4+ cell counts must be above or equal to 350 cells/µl, 2-3 occasional determinations below 350 cells/μl are allowed.
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- Current CD4+ cell count must be at least 450 cells/µl
- HIV-RNA must be below 50 copies/ mL for the last 12 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 500 copies/mL are permitted)
- If male or female of childbearing potential willing to take correct contraceptive measures:
- If heterosexually active female; using an effective method of contraception from 14 days prior to the first vaccination until at least 12 weeks after the last vaccination; all female volunteers must be willing to undergo urine or serum pregnancy tests at time points specified in the Schedule of Procedures.
- If heterosexually active male; willing to use an effective method of contraception or agree on the use of an effective method of contraception by his partner from the day of the first vaccination until 12 weeks after the last vaccination.
- If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (which could include pre-exposure prophylaxis [PrEP] for their sexual partners)
Who cannot join
- Treatment with a non-cART regimen of antiretroviral agents prior to the start of any antiretroviral regimen
- History of a CDC class C event (see Appendix IV)
- Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period.
- Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit
- Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit
- Use of anti-coagulant medication
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- Use of any investigational drug during the 90 days prior to study entry
- Previous antiretroviral therapy failure and/or mutations conferring genotypic resistance to antiretroviral therapy
- Participants with severe cardiovascular diseases or long QT interval
- Active hepatitis C virus
- Hepatitis B infection
- Treatment with strong inhibitors or inducers of CYP3A4, except protease inhibitors for HIV treatment (see protocol section 5.7); if in treatment of protease inhibitors for HIV not willing to change inhibitor protease for an integrase inhibitor during the study.
- Any known allergy or intolerance to any of the study drugs or excipient
- Protein egg allergy
- Known past history of clinical Epstein-Barr Virus (EBV) infection or recurrent herpes zoster
- Hematologic abnormalities ≥Grade 1
- Potassium or magnesium levels outside the upper limit of normal (ULN) and lower limit of normal (LLN)
- History of autoimmune disorders as multiple sclerosis.
- Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
About this study
Official title: A Phase I/IIa, Randomised Study to Evaluate the Safety and the Effectiveness of a Combination of Therapeutic Vaccine, Broadly Neutralising Antibody (10-1074), and the Latency Reversing Agent Romidepsin to Achieve a Remission of HIV Infection in Chronically HIV-infected Participants Under Stable Combined Antiretroviral Therapy.
A phase I/IIa, multinational, multicentric (IDIBAPS, IRSICAIXA, AARHUS, VUB, APHP), randomised, balanced by centre (to include participants from the 4 arms), open-label, controlled clinical trial. Each participant will be followed up a different time according to study arm: a minimum of 38 weeks in arm I, 31 weeks in arm II, 54 weeks in arm III and 26 weeks in the arm 4. The study duration will be 104 weeks from inclusion of the first participant.
Participants will be randomised to one of the following 4 arms:
- Arm 1 (study): 14 participants will receive 3 vaccines of HIVARNA01.3 prime, 2 MVA-vectored vaccine boosts, 1 dose of 10-1074 antibodies and 3 doses of romidepsin
- Arm 2 (study): 14 participants will receive 5 vaccines of HIVARNA01.3, 1 dose of 10-1074 antibodies and 3 doses of romidepsin
- Arm 3 (study): 14 participants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 1 dose of 10-1074 antibodies and 3 doses of romidepsin
- Arm 4 (control): 14 participants 1 dose of 10-1074 antibodies and 3 doses of romidepsin
- Conditions
- HIV Infections
- Being tested
- HIVACAR, placebo
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVACAROther
Participants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 2 doses of 10-1074 antibodies and 3 doses of romidepsin
placeboOther
Participants will receive 5 vaccines of placebo of HIVACAR01, 2 doses of 10-1074 antibodies and 3 doses of romidepsin
| Study group | Role | What they receive |
|---|---|---|
| HIVACAR | Experimental | Participants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 2 dose of 10-1074 antibodies and 3 doses of romidepsin Receives: Other: HIVACAR |
| Placebo | Placebo comparator | Participants will receive 5 doses of placebo, 2 doses of 10-1074 antibodies and 3 doses of romidepsin Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or above severe local , systemic, clinical or laboratory adverse event t
Local adverse events may be pain, cutaneous reactions including induration and systemic emperature, chills, headache, nausea, vomiting, malaise, and myalgia. Clinical and laboratory must be confirmed at examination or on repeat testing respectively. Any adverse event attributable to the combination therapy leading to discontinuation of the study treatmen
Measured: 12 days (28 days after each inmuisation)
Secondary outcomes (22)
Proportion of participants who maintain an undetectable viral load
defined as a viral load below the threshold of 50 copies/ml
Measured: 12 weeks (after discontinuation of antiretroviral therapy)
Percentage of participants with control of viral load below detectable level
Measured: 24 weeks (after discontinuation of antiretroviral therapy)
Change from baseline in total proviral HIV-1 DNA per 10^6 CD4+ T cells.
Measured: up to 51 weeks
Change from baseline in integrated proviral HIV-1 DNA per 10^6 CD4+ T cells.
Measured: up to 51 weeks
Change from baseline in HIV-1 transcription.
According to CA US HIV-1 RNA measured in unfractionated CD4+ T cells
Measured: up to 39 weeks
Change in plasma HIV-1 RNA from baseline
Measured: up to 39 weeks
Breadth and magnitude of CD4+ HIV-specific T cell responses measured by IFN-gamma ELISPOT compared with baseline.
Measured: up to 27 weeks
Breadth and magnitude of CD8+ HIV-specific T cell responses measured by IFN-gamma ELISPOT compared with baseline.
Measured: up to 27 weeks
Breadth and magnitude of CD4+ HIV-specific T cell responses measured by Intra-cellular cytokine staining-ICS in the study arms as compared with baseline.
Measured: up to 27 weeks
Breadth and magnitude of CD8+ HIV-specific T cell responses measured by Intra-cellular cytokine staining-ICS in the study arms as compared with baseline.
Measured: up to 27 weeks
Change from baseline in CD8+ T-cell HIV suppressive capacity.
Measured: up to 51 weeks
Change from baseline in T cell activation markers
Measured: up to 29 weeks
Change from baseline in T cell activation markers
Measured: 3 weeeks
Change from baseline in T cell activation markers
Measured: up to 24 weeks
Change from baseline in T cell subset distribution
Measured: up to 29 weeks
Change from baseline in T cell subset distribution
Measured: 14 weeks
Change from baseline in T cell subset distribution
Measured: up to 27 weeks
Change from baseline in PD-1 expression
Measured: up to 51 weeks
Evaluate fecal microbiome
Measured: baseline and at week 14
Characterise viral escape from vaccine-induced immune T cell responses
Comparison of viral sequences pre-cART and rebounding after cART interruption
Measured: up to 51 weeks
Analysis of changes in sensitivity to neutralisation by 10-1074 of rebounding viruses after cART interruption to identify neutralisation escape mutants.
Measured: up to 51 weeks
To evaluate mRNA expression profiles in whole PBMC at baseline
Measured: at first romidepsin administration and 14 and 26 weeks after first romidepsin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Nov 2020 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Why it stopped: The clinical trial was discontinued prior to initiation due to the withdrawal of the vaccine manufacturer (etherRNA) from the research consortium. As a result, the study could not proceed as originally planned.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judit Pich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Judit Pich, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619278
- Sponsor's protocol ID
- 2017-000566-30
- Other IDs
- 2017
- Acronym
- HIVACAR
- Status last verified
- Sep 2025
- First submitted
- 14 Mar 2018
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Randomised Study to Evaluate the Safety and the Effectiveness of a Combination of Therapeutic Vaccine, Broadly Neutralising Antibody (10-1074), and the Latency Reversing Agent Romidepsin to Achieve a Remission of HIV Infection in Chronically HIV-infected Participants Under Stable Combined Antiretroviral Therapy.
- ClinicalTrials.gov ID
- NCT03619278
- Acronym / sponsor ID
- HIVACAR / 2017-000566-30
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The clinical trial was discontinued prior to initiation due to the withdrawal of the vaccine manufacturer (etherRNA) from the research consortium. As a result, the study could not proceed as originally planned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Judit PichUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 7 Aug 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.
A phase I/IIa, multinational, multicentric (IDIBAPS, IRSICAIXA, AARHUS, VUB, APHP), randomised, balanced by centre (to include participants from the 4 arms), open-label, controlled clinical trial. Each participant will be followed up a different time according to study arm: a minimum of 38 weeks in arm I, 31 weeks in arm II, 54 weeks in arm III and 26 weeks in the arm 4. The study duration will be 104 weeks from inclusion of the first participant.
Participants will be randomised to one of the following 4 arms:
- Arm 1 (study): 14 participants will receive 3 vaccines of HIVARNA01.3 prime, 2 MVA-vectored vaccine boosts, 1 dose of 10-1074 antibodies and 3 doses of romidepsin
- Arm 2 (study): 14 participants will receive 5 vaccines of HIVARNA01.3, 1 dose of 10-1074 antibodies and 3 doses of romidepsin
- Arm 3 (study): 14 participants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 1 dose of 10-1074 antibodies and 3 doses of romidepsin
- Arm 4 (control): 14 participants 1 dose of 10-1074 antibodies and 3 doses of romidepsin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIVACAR | Experimental | Other: HIVACARParticipants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 2 dose of 10-1074 antibodies and 3 doses of romidepsin |
| Placebo | Placebo comparator | Other: placeboParticipants will receive 5 doses of placebo, 2 doses of 10-1074 antibodies and 3 doses of romidepsin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Between ≥ 18 to <60 years of age
- Voluntarily signed informed consent
- Male, or female with negative pregnancy test prior to enrolment
- Proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA before cART)
- Must be on stable treatment with cART for at least 18 months (cART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents; periods of mono/dual antiretroviral therapy if not first time therapy and confirmed viral suppression during these periods of mono/dual therapy are permitted)
Key exclusion criteria (19 listed)
- Treatment with a non-cART regimen of antiretroviral agents prior to the start of any antiretroviral regimen
- History of a CDC class C event (see Appendix IV)
- Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period.
- Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit
- Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit
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 |
|---|---|---|
| HIVACARParticipants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 2 doses of 10-1074 antibodies and 3 doses of romidepsin | Other | HIVACAR |
| placeboParticipants will receive 5 vaccines of placebo of HIVACAR01, 2 doses of 10-1074 antibodies and 3 doses of romidepsin | Other | Placebo |
Primary outcome
Grade 3 or above severe local , systemic, clinical or laboratory adverse event t
Time frame: 12 days (28 days after each inmuisation)
Local adverse events may be pain, cutaneous reactions including induration and systemic emperature, chills, headache, nausea, vomiting, malaise, and myalgia. Clinical and laboratory must be confirmed at examination or on repeat testing respectively. Any adverse event attributable to the combination therapy leading to discontinuation of the study treatmen
22 secondary outcomes
Proportion of participants who maintain an undetectable viral load
Time frame: 12 weeks (after discontinuation of antiretroviral therapy)
Percentage of participants with control of viral load below detectable level
Time frame: 24 weeks (after discontinuation of antiretroviral therapy)
Change from baseline in total proviral HIV-1 DNA per 10^6 CD4+ T cells.
Time frame: up to 51 weeks
Change from baseline in integrated proviral HIV-1 DNA per 10^6 CD4+ T cells.
Time frame: up to 51 weeks
Change from baseline in HIV-1 transcription.
Time frame: up to 39 weeks
Change in plasma HIV-1 RNA from baseline
Time frame: up to 39 weeks
Breadth and magnitude of CD4+ HIV-specific T cell responses measured by IFN-gamma ELISPOT compared with baseline.
Time frame: up to 27 weeks
Breadth and magnitude of CD8+ HIV-specific T cell responses measured by IFN-gamma ELISPOT compared with baseline.
Time frame: up to 27 weeks
Breadth and magnitude of CD4+ HIV-specific T cell responses measured by Intra-cellular cytokine staining-ICS in the study arms as compared with baseline.
Time frame: up to 27 weeks
Breadth and magnitude of CD8+ HIV-specific T cell responses measured by Intra-cellular cytokine staining-ICS in the study arms as compared with baseline.
Time frame: up to 27 weeks
Change from baseline in CD8+ T-cell HIV suppressive capacity.
Time frame: up to 51 weeks
Change from baseline in T cell activation markers
Time frame: up to 29 weeks
Change from baseline in T cell activation markers
Time frame: 3 weeeks
Change from baseline in T cell activation markers
Time frame: up to 24 weeks
Change from baseline in T cell subset distribution
Time frame: up to 29 weeks
Change from baseline in T cell subset distribution
Time frame: 14 weeks
Change from baseline in T cell subset distribution
Time frame: up to 27 weeks
Change from baseline in PD-1 expression
Time frame: up to 51 weeks
Evaluate fecal microbiome
Time frame: baseline and at week 14
Characterise viral escape from vaccine-induced immune T cell responses
Time frame: up to 51 weeks
Analysis of changes in sensitivity to neutralisation by 10-1074 of rebounding viruses after cART interruption to identify neutralisation escape mutants.
Time frame: up to 51 weeks
To evaluate mRNA expression profiles in whole PBMC at baseline
Time frame: at first romidepsin administration and 14 and 26 weeks after first romidepsin administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HIVACAR in people with HIV Infections, run by Judit Pich.
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 12 inclusion and 19 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: withdrawn, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Grade 3 or above severe local , systemic, clinical or laboratory adverse event t (time frame: 12 days (28 days after each inmuisation)). 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 11 Sep 2025.