Overview

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

Status:
Completed
Trial end date:
2017-10-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IrsiCaixa
Collaborators:
BCN Checkpoint
BCN-Checkpoint
Fundacio Lluita Contra la SIDA
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Germans Trias i Pujol Hospital
HIVACAT
Hospital Clinic of Barcelona
Hospital de Sant Pau
University of Oxford
Treatments:
Histone Deacetylase Inhibitors
Romidepsin
Vaccines
Criteria
Inclusion Criteria:

1. Subject included in ChAd-MVA.HIVconsv_BCN01 study with complete follow-up and included
in BCN01-RO extension study.

2. Optimal virological suppression for at least 3 years.cop/ml).

3. Being on a non-boosted integrase-inhibitor based regimen (raltegravir or dolutegravir)
for at least 4 weeks at screening visit.

4. 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

5. CD4 T cell count ≥500 cells/mm3

Exclusion Criteria:

1. Positive pregnancy test.

2. Presence of resistance drug mutations in the screening genotype

3. History of autoimmune disease other than HIV-related auto-immune disease.

4. Treatment for cancer or lymphoproliferative disease within 1 year of study entry

5. 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

6. Current or recent use (within last 3 months) of interferon or systemic corticosteroids
or other immunosuppressive agents