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
Interventions
Product Name: MVA HIV-B
Product Code: MVATG17401
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: MODIFIED VIRUS ANKARA (MVA) STRAIN
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. Willing and able to provide written informed consent 5. Nadir CD4 count > 300 cells/mm3 6. CD4 count at screening > 500 cells/mm3 7. Viral load =65 years) yes F.1.3.1 Number of subjects for this age range 69
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 = 39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours 27. Grade 2 or worse routine laboratory parameters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome is the area under the HIV RNA curve from treatment interruption (scheduled at week 18 after entering the trial). HIV RNA is determined by the local laboratory using a standard assay. ;Timepoint(s) of evaluation of this end point: The time points for the primary outcome are all weekly visits from week 19 (visit 11) through to week 42 (visit 34). ;Main Objective: The main objective of the study will be to assess the impact of vedolizumab and vaccination with MVA 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 vedolizumab/vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary virological outcomes: - Time from treatment interruption (scheduled for 18 weeks after entering the trial) to the earliest of reaching HIV RNA = 100 000 copies/ml (confirmed on a separate sample) or resuming antiretroviral therapy for any reason over a period of 24 weeks - Level of HIV total RNA - First local maximum (peak) level of HIV total RNA during treatment interruption - Rate of increase of HIV total RNA between the last measure below the lower detection limit (LDL) and the first local maximum - Setpoint Secondary safety outcomes: - Grade 3 and worse solicited clinical and laboratory adverse events - Any adverse event leading to interruption in the vaccine/placebo or vedolizumab/placebo schedule - Any event that results in resuming treatment during the ATI - Serious Adverse Events - Other clinical and laboratory adverse events - Change in absolute CD4 - Time to VL suppression after restarting ART ; Timepoint(s) of evaluation of this end point: The time points for the secondary virological outcomes are all weekly visits from week 19 (visit 11) through to week 42 (visit 34). Secondary safety outcomes are assessed at all visits except at week -6 (visit 1). | — |
Countries
France, Germany, Italy, Spain, Switzerland, United Kingdom
Contacts
Public ContactEHVA
MRC CTU at UCL
Outcome results
None listed