A Phase 1 interventional study of MVA.HIVconsv vaccine and Romidepsin in HIV, sponsored by IrsiCaixa. Completed at 2 sites in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by IrsiCaixa · Phase 1, Interventional, and Treatment
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.
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.
IrsiCaixa is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Haematological and biochemical laboratory parameters as follows:
Exclusion Criteria:
MVA.HIVconsv plus romidepsin
Drug: MVA.HIVconsv vaccine · Drug: Romidepsin
Dose: 2x10e8 pfu, Interval: weeks 0 and 9.
Dose: 5mg/m2 over 4hours, Interval: weeks 3, 4 and 5
Number of participants with grade >=3 adverse events assessed by Division of AIDS (DAIDS) grading table
Grade \>=3 adverse events
Time frame: Through study completion, maximum 75 weeks
Number of participants with serious adverse events
Serious adverse events
Time frame: Through study completion, maximum 75 weeks
Viral reservoir measured by total HIV-1 DNA copies per 10e6 CD4+ T cells
Total HIV-1 DNA copies per 10e6 CD4+ T cells
Time frame: From baseline to visit week 6 (romidepsin 3 + 1 week)
Romidepsin Cmax
RMD plasma concentrations will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS)
Time frame: week 3
Romidepsin Cmax
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 4
Romidepsin Cmax
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 5
Romidepsin Cmin
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 3
Romidepsin Cmin
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 4
Romidepsin Cmin
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 5
Romidepsin area under curve (AUC)
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 3
Romidepsin AUC
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 4
Romidepsin AUC
RMD plasma concentrations will be measured by LC-MS/MS
Time frame: week 5
HIV-1 expression in resting CD4+ T-cells measured by CA-RNA and single-copy assay (SCA)
Time frame: week 6
Levels of Histone H3 acetylation in lymphocytes
Time frame: week 6
CTL toxicity assessment based on viability, activation or exhaustion (most relevant marker according to previous studies)
Time frame: week 6
HIVconsv-specific T cell responses will be measured by IFNg ELISPOT using peptide pools covering different HIV proteins and HIVcons sequences.
Time frame: week 6
Viral suppressive capacity of CD8+ T cells in vitro, using a flow cytometric assay
Time frame: Baseline
Viral suppressive capacity of CD8+ T cells in vitro, using a flow cytometric assay
Time frame: Week 17
Proportion of individuals who initiate a MAP following the futility analysis
Time frame: Week 17
Proportion of individuals who maintain sustained plasma viral load (pVL) <2,000 copies/ml
Time frame: Week 29
Proportion of individuals in whom cART is reinitiated due to viral rebound
Time frame: Up to 51 weeks
Emergence of viral resistance during MAP phase
Description of viral resistance emerged, genotype.
Time frame: Up to 51 weeks
Proportion of patients with viral suppression 6 months after treatment resumption.
Time frame: 24 weeks after treatment resumption (up to 75 weeks).
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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IrsiCaixa