Human immunodeficiency virus type 1 MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: MVA.HTI
Product Code: MVA.HTI
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: MVA.HTI
Current Sponsor code: MVA.HTI
Concentration unit: PFU plaque forming unit
Concent
Sponsors
AELIX Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Understands the study information provided and is capable of giving written informed consent. 2.Has confirmed HIV-1 infection 3.Has received ART, defined as =3 antiretroviral drugs, that was initiated within 6 months of the estimated date of HIV-1 acquisition. The ART regimen is required to have included =3 antiretroviral drugs at the time of treatment initiation and is required to include =3 antiretroviral drugs at screening, but temporary use of a 2drug ART regimen during the time between ART initiation and the screening visit is permitted. 4.Has plasma HIV-1 RNA levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Is pregnant or lactating at the screening visit or is planning on becoming pregnant over the duration of the study 2. If available, has genotypic data (e.g., HIV genotype data) that demonstrate the presence of clinically significant mutations that would prevent the construction of a viable ART regimen post-treatment interruption 3. Has reported multiple (consult with medical monitor) periods of suboptimal adherence to ART. 4. Has a history of past ART interruptions lasting longer than 2 weeks 5. Has participated in another interventional clinical study within 30 days before the screening visit 6. Has any acquired immune deficiency syndrome (AIDS) defining disease or progression of HIV related disease within 90 days of the screening visit 7. Has a history of any moderate and/or severe autoimmune disease (consult with medical monitor). 8. Has a history or clinical manifestations of any physical or psychiatric disorder that could impair the participant’s ability to complete the study 9. Is taking HIV protease inhibitors (including low-dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine or nevirapine. Participants on prohibited ART medications will be allowed to switch to an accepted treatment between screening and baseline; participants must be on the new ART regimen at least 14 days prior to the collection of screening laboratory samples. The baseline visit should be completed once all screening laboratory results are available and reviewed. 10. Is taking any other concomitant treatments non compatible with vesatolimod before starting treatment in the study. Participants on non compatible medications at screening (e.g., atorvastatin) will be allowed to switch treatments; participants who switch medications must be stopped at least 30 days prior to the first dose of vesatolimod. 11. Has received approved vaccines within 2 weeks of study entry or has had a previous immunisation with any experimental immunogens within the previous 2 years. 12. Will receive any vaccines within 4 weeks prior to, or 2 weeks after any of the planned CCMM administrations or on a week when vesatolimod is administered 13. Has a history of anaphylaxis or a severe adverse reaction to vaccines 14. Has received blood products within 6 months of the screening visit 15. Has received treatment for cancer or lymphoproliferative disease within 1 year of screening 16. Has received any other current or prior therapy within 30 days prior to the screening visit that, in the opinion of the investigators and/or the sponsor, would make the participant unsuitable for the study or influence the results of the study. 17. Has current or has had recent use (within last 3 months before the screening visit) of IFN or systemic corticosteroids or other immunosuppressive agents (use of inhaled steroids for pulmonary conditions or topic steroids for localised skin conditions is permitted) 18. Have abnormalities of haematology, clinical chemistry and microbiology as below • Haemoglobin 1.3 × upper limit of normal (ULN) •Aspartate aminotransferase >2.5 × ULN •Alanine aminotransferase >2.5 × ULN Microbiology •Positive hepatitis B surface antigen •Positive for hepatitis C antibody, unless confirmed clearance o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of the CCMM (ChAdOx1.HTI + MVA.HTI) + Vesatolimod regimen during Period 1 (week 0 to 48) in early treated HIV 1 infection;Secondary Objective: Safety •To evaluate the safety of the CCMM + Vesatolimod regimen after period 1 in early treated HIV-1 infection Efficacy •To evaluate whether CCMM + vesatolimod is able to prevent or delay viral rebound, induce post-rebound viral control, and/or prevent or delay the need for resumption of antiretroviral therapy (ART) following an analytical treatment interruption (ATI) in early treated HIV-1 infection Immunogenicity •To evaluate the immunogenicity of CCMM + vesatolimod in early treated HIV-1 infection;Primary end point(s): •Proportion of participants developing solicited Grade 3 or 4 local reactions •Proportion of participants developing solicited Grade 3 or 4 systemic reactions •Proportion of participants developing SAEs (Serious Adverse Events);Timepoint(s) of evaluation of this end point: In the 7 days period following administration of IMPs during period 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety a) Proportion of participants developing treatment-emergent adverse event (TEAEs) during period 1. b)Proportion of participants developing TEAEs after period 1 c)Proportion of participants developing SAEs after period 1 d) Proportion of participants who achieve virologic suppression (<50 copies/mL) after resumption of ART at week 84. Efficacy a) Proportion of participants in Period 2 with viral load < 50 copies/mL below at week 12 and 24 weeks after the start of analytical treatment interruption (ATI) b) Proportion of participants in Period 2 with viral load <2000 copies/mL at 12 and 24 weeks after the start of ATI. c) Proportion of participants in Period 2 that remain off antiretroviral therapy (ART) at 12 and 24 weeks after the start of ATI d)Time to plasma viral load [pVL] =50 copies/mL during ATI for participants in Period 2 e)Time to pVL =10,000 copies/mL) during ATI for participants in Period 2 f)Time to ART resumption from the start of ART interruption for participants in Period 2 Immunogenicity: •Proportion of participants with de-novo T cell responses to HTI encoded regions during Period 1 as determined by IFN gamma enzyme-linked immunospot (ELISPOT) assay •Breadth and magnitude of total vaccine-induced HIV-1 specific T cell responses during Period 1 as measured by IFN gamma ELISPOT;Timepoint(s) of evaluation of this end point: Safety a,b, c: After Period 1. d) after resumption of ART Efficacy: in period 2 Immunology: during period 1 | — |
Countries
Spain
Contacts
Public ContactAnne Leselbaum
AELIX Therapeutics
Outcome results
None listed