CompletedPhase 1

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

Spain15 participantsStarted 2016-02

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. CD4 T cell count ≥500 cells/mm3

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: Through study completion, maximum 75 weeks

Number of participants with serious adverse events

Timeframe: Through study completion, maximum 75 weeks

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

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

Trial details

NCT IDNCT02616874

SponsorIrsiCaixa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More HIV trials

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. CD4 T cell count ≥500 cells/mm3

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: Through study completion, maximum 75 weeks

Number of participants with serious adverse events

Timeframe: Through study completion, maximum 75 weeks

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

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