NCT02616874

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 hiv

Timeline
Completed

Started Feb 2016

Typical duration for phase_1 hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

November 9, 2015

Last Update Submit

May 6, 2024

Conditions

HIV

Keywords

HIV infectionEarly treatmentRomidepsinHDACiTherapeutic VaccinesHIVconsvHIV reservoirPopulation PK/PD analysis

Outcome Measures

Primary Outcomes (3)

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

    Grade \>=3 adverse events

    Through study completion, maximum 75 weeks

  • Number of participants with serious adverse events

    Serious adverse events

    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

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

Secondary Outcomes (20)

  • Romidepsin Cmax

    week 3

  • Romidepsin Cmax

    week 4

  • Romidepsin Cmax

    week 5

  • Romidepsin Cmin

    week 3

  • Romidepsin Cmin

    week 4

  • +15 more secondary outcomes

Study Arms (1)

MVA.HIVconsv plus romidepsin

EXPERIMENTAL

MVA.HIVconsv plus romidepsin

Drug: MVA.HIVconsv vaccineDrug: Romidepsin

Interventions

MVA.HIVconsv vaccineDRUG

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

MVA.HIVconsv plus romidepsin
RomidepsinDRUG

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

MVA.HIVconsv plus romidepsin

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
  • Creatinine ≤ 1.3 x ULN
  • CD4 T cell count ≥500 cells/mm3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Clinic Hospital

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 34750296DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 30, 2015

Study Start

February 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 30, 2017

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations

ES(2)