Human Immunodeficiency Virus (HIV) infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Inserm-ANRS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1-infected 2.Aged 18 – 65 years old on the day of screening 3. Weight >50kg 4. Written informed consent 5. Nadir CD4 count > 300 cells/mm3 6. CD4 count at screening > 600 cells/mm3 7. Viral load, =65 years) yes F.1.3.1 Number of subjects for this age range 192
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating 2. HIV-2 infection (either isolated or associated with HIV-1) 3. VL >200 copies/ml on 2 occasions in the 12 months prior to screening 4. Previous interruptions in cART 5. Previous virological failures defined by loss of virological suppression with the presence of resistant mutations 6. Haemoglobin (Hb= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours 27. Grade 2 or worse routine laboratory parameters. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study will be to assess the impact of vaccination (with DNA, MVA and/or vedolizumab) upon viral control following analytic treatment interruption (ATI).;Secondary Objective: We also plan to undertake a comprehensive analysis of the relationships between a range of biomarkers (including immune responses) and virological control, independent of vaccination/mAb.; Primary end point(s): Efficacy: Time from treatment interruption (scheduled for 24 weeks after enrolment) to the earliest time of reaching: - Confirmation of HIV RNA = 10,000 copies/ml on a separate sample - Resuming antiretroviral therapy for any reason over a period of 24 weeks. Safety: - A clinical decision to discontinue the regimen for an adverse event that is considered related to product. ; Timepoint(s) of evaluation of this end point: The timepoints for the primary virological outcome measure are every week from week 25 through to week 48. Adverse events will be assessed at all weeks (except weeks -6, 12+1day, 25, 27, 29, 30, 33 and 35). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary virological efficacy outcome measures: - Level of HIV total DNA - Cell Associated (CA) HIV RNA Quantification Secondary safety outcome measures: - Grade 3 and worse solicited clinical and laboratory adverse events - Any adverse event leading to interruption in the vaccine or vedolizumab schedule - Any event that results in resuming treatment during the ATI - Serious Adverse Events - Other clinical and laboratory adverse events - Time to VL suppression after restarting ART Secondary Immunological Outcomes: - Response rate, magnitude and polyfunctionality of vaccine induced CD4 and CD8 T-cell responses. ; Timepoint(s) of evaluation of this end point: Secondary virological outcomes will be assessed in all patients at week 24 and before cART is resumed and at Baseline if relevant. Depending on the results, secondary virological outcomes may be assessed at other timepoints. Adverse events will be assessed at all weeks (except weeks -6, 12+1day, 25, 27, 29, 30, 33 and 35). Secondary immunological outcomes will be assessed 2 weeks after the final immunisation at week 14. Depending on the results, secondary immunological outcomes may be assessed at other timepoints. | — |
Countries
France, Germany, Italy, Spain, Switzerland, United Kingdom
Contacts
Public ContactEHVA
MRC CTU at UCL
Outcome results
None listed