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AzTrials

HIVPhase 1NCT02616874

Study to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals

A Phase 1 study testing MVA.HIVconsv vaccine and Romidepsin in people with HIV, run by IrsiCaixa at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The BCN02-Romi study aims to evaluate a combined "kick and kill" strategy using the most immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency reversal agent available at present time (romidepsin) in a cohort of early-treated HIV positive individuals. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
HIV
What is being tested?
MVA.HIVconsv vaccine and Romidepsin
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesSpain
Study dates
Feb 2016to 30 Oct 2017
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject included in ChAd-MVA.HIVconsv_BCN01 study with complete follow-up and included in BCN01-RO extension study.
  • Optimal virological suppression for at least 3 years.cop/ml).
  • Being on a non-boosted integrase-inhibitor based regimen (raltegravir or dolutegravir) for at least 4 weeks at screening visit.
  • Haematological and biochemical laboratory parameters as follows:
  • Haemoglobin > 10g/dl
  • Platelets > 100.000/dl
Show all 9Show fewer
  • Alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Creatinine ≤ 1.3 x ULN
  • CD4 T cell count ≥500 cells/mm3

Who cannot join

  • Positive pregnancy test.
  • Presence of resistance drug mutations in the screening genotype
  • History of autoimmune disease other than HIV-related auto-immune disease.
  • Treatment for cancer or lymphoproliferative disease within 1 year of study entry
  • Any other prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
  • Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Germans Trias i Pujol Hospital

    Badalona, Barcelona, 08916

  • Clinic Hospital

    Barcelona, 08036

Other trials in Spain

About this study

Official title: An Open Label Phase I Trial to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals (BCN02-Romi)

The BCN02-Romi study aims to evaluate a combined "kick and kill" strategy using the most immunogenic candidate vaccine available so far (HIVconsv) with the strongest latency reversal agent available at present time (romidepsin) in a cohort of early-treated HIV positive individuals.

Read the detailed description

The combined use of therapeutic vaccination and specific drugs that can reactivate latent virus from the reservoir (Kick and kill strategies) hold the promise to achieve functional cure and viral eradication of HIV infection. The present project consists of a proof-of-concept clinical trial in a cohort of 24 early treated HIV-1 infected individuals rolled-over from the BCN01 vaccine clinical trial in which participants received the most immunogenic vaccines tested to date, ChAd and modified vaccinia Ankara (MVA).HIVconsv vaccines. All individuals will be given a booster immunization with MVA.HIVconsv in combination with romidepsin (RMD), a potent histone deacetylation inhibitor (HDACi) and will later undergo a monitored antiretroviral pause. HIVconsv vaccines have specifically been designed to stimulate a broad and potent cytotoxic T cell (CTL) response towards the most conserved viral regions of the HIV-1 proteome, which have recently been suggested to have a crucial role when targeting HIV variants harboured in the latent reservoir with mutations to escape T-cell immune responses. The study includes the development of a population pharmacokinetic/pharmacodynamic (PK/PD) substudy to analyse the in vivo effects of RMD in the induction of HIV expression in resting cells, deeply investigate any unintended effect on the CTL function as well as predict the relationship between RMD exposure and such effects. The investigators' results will allow investigators to optimize RMD dosing, to evaluate the clinical efficacy of this eradication strategy after the cART interruption and to identify better correlates of control of rebound viremia after cessation of treatment.

Conditions
HIV
Being tested
MVA.HIVconsv vaccine, Romidepsin
Keywords
HIV infection, Early treatment, Romidepsin, HDACi, Therapeutic Vaccines, HIVconsv, HIV reservoir, Population PK/PD analysis
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVA.HIVconsv vaccineDrug

    Dose: 2x10e8 pfu, Interval: weeks 0 and 9.

  • RomidepsinDrug

    Dose: 5mg/m2 over 4hours, Interval: weeks 3, 4 and 5

Study groups in NCT02616874
Study groupRoleWhat they receive
MVA.HIVconsv plus romidepsinExperimentalMVA.HIVconsv plus romidepsin
Receives: Drug: MVA.HIVconsv vaccine; Drug: Romidepsin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with grade >=3 adverse events assessed by Division of AIDS (DAIDS) grading table

    Grade >=3 adverse events

    Measured: Through study completion, maximum 75 weeks

  2. Number of participants with serious adverse events

    Serious adverse events

    Measured: Through study completion, maximum 75 weeks

  3. Viral reservoir measured by total HIV-1 DNA copies per 10e6 CD4+ T cells

    Total HIV-1 DNA copies per 10e6 CD4+ T cells

    Measured: From baseline to visit week 6 (romidepsin 3 + 1 week)

Secondary outcomes (20)

  1. Romidepsin Cmax

    RMD plasma concentrations will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS)

    Measured: week 3

  2. Romidepsin Cmax

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 4

  3. Romidepsin Cmax

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 5

  4. Romidepsin Cmin

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 3

  5. Romidepsin Cmin

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 4

  6. Romidepsin Cmin

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 5

  7. Romidepsin area under curve (AUC)

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 3

  8. Romidepsin AUC

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 4

  9. Romidepsin AUC

    RMD plasma concentrations will be measured by LC-MS/MS

    Measured: week 5

  10. HIV-1 expression in resting CD4+ T-cells measured by CA-RNA and single-copy assay (SCA)

    Measured: week 6

  11. Levels of Histone H3 acetylation in lymphocytes

    Measured: week 6

  12. CTL toxicity assessment based on viability, activation or exhaustion (most relevant marker according to previous studies)

    Measured: week 6

  13. HIVconsv-specific T cell responses will be measured by IFNg ELISPOT using peptide pools covering different HIV proteins and HIVcons sequences.

    Measured: week 6

  14. Viral suppressive capacity of CD8+ T cells in vitro, using a flow cytometric assay

    Measured: Baseline

  15. Viral suppressive capacity of CD8+ T cells in vitro, using a flow cytometric assay

    Measured: Week 17

  16. Proportion of individuals who initiate a MAP following the futility analysis

    Measured: Week 17

  17. Proportion of individuals who maintain sustained plasma viral load (pVL) <2,000 copies/ml

    Measured: Week 29

  18. Proportion of individuals in whom cART is reinitiated due to viral rebound

    Measured: Up to 51 weeks

  19. Emergence of viral resistance during MAP phase

    Description of viral resistance emerged, genotype.

    Measured: Up to 51 weeks

  20. Proportion of patients with viral suppression 6 months after treatment resumption.

    Measured: 24 weeks after treatment resumption (up to 75 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionSep 2016
  4. Study completion30 Oct 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616874
Sponsor's protocol ID
BCN02-Romi
Status last verified
May 2024
First submitted
9 Nov 2015
Last updated
7 May 2024
Results posted
No
Data monitoring committee
No

Publications

  • Munoz-Moreno JA, Carrillo-Molina S, Martinez-Zalacain I, Miranda C, Manzardo C, Coll P, Meulbroek M, Hanke T, Garolera M, Miro JM, Brander C, Clotet B, Soriano-Mas C, Molto J, Mothe B; BCN02-Neuro Substudy Group. Preserved central nervous system functioning after use of romidepsin as a latency-reversing agent in an HIV cure strategy. AIDS. 2022 Mar 1;36(3):363-372. doi: 10.1097/QAD.0000000000003121.

    PubMed 34750296

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA.HIVconsv vaccine and Romidepsin in people with HIV, run by IrsiCaixa at 2 sites in Spain.

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 9 inclusion and 6 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 7 May 2024. 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 Spain. 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?

Number of participants with grade >=3 adverse events assessed by Division of AIDS (DAIDS) grading table (time frame: Through study completion, maximum 75 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616874, which also lists 1 linked publication.

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 7 May 2024.

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