Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02888756
Status:
TERMINATED
Last Update Posted:
2019-12-23
First Post:
2016-08-23
Brief Title:
iHIVARNA Clinical Trial in HIV Infected Individuals
Sponsor:
Rob Gruters
Organization:
Erasmus Medical Center
Study Overview
Official Title:
A Phase IIa Randomized Placebo Controlled Double Blinded Study to Evaluate the Safety and Immunogenicity of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis did not show sufficient immunogenicity of IMP compared to placebo
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iHIVARNA-01
Brief Summary:
iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients based on in vivo modification of DCs It consists of HIVACAT-TriMix mRNA encoding a mixture of APC activation molecules CD40L a constitutively active variant of TLR4 and CD70 and the HIV target antigens contained in HIVACAT to be administered through the intranodal route iHIVARNA-01 aims to achieve the functional cure of HIV infection ie controlling viral replication in the absence of anti-retroviral therapy
Detailed Description:
Objective To evaluate the safety and immunogenicity of iHIVARNA-01 as a new therapeutic vaccine in HIV infected patients
Study design and duration Phase IIa multicentre double-blind placebo controlled intervention study Each patient will be followed for 30 weeks The study duration will be 38 weeks from inclusion of the first patient
Sites Erasmus MC Rotterdam The Netherlands sponsor Hospital Clínic de Barcelona and Institut de Recerca de la Sida - Caixa Barcelona Spain Instituut voor Tropische Geneeskunde Antwerp Belgium and Vrije Universiteit BrusselUZ Brussel Belgium
Study population Chronically HIV-1- infected patients under stable cART with plasma viral load pVL 50 copiesml and stable CD4 T-cell counts 450μl aged 18 years or above
Sample size after recruitment and screening 70 patients will be included and randomized to one of the study-arms
Intervention One group n40 receives the HIVACAT-TriMix 300 microgram TriMix 900 microgram HIVACAT vaccine intranodally on three occasions with a two-week interval One control group n15 receives TriMix only 300 microgram TriMix and one group n15 receives saline intranodally on three occasions with a two-week interval Two weeks after the last vaccination cART treatment will be interrupted If plasma virus is detectable cART will be re-initiated twelve weeks after treatment interruption cART can always be re-initiated for medical reasons as judged by the clinical investigator
Study design and duration Phase IIa multicentre double-blind placebo controlled intervention study Each patient will be followed for 30 weeks The study duration will be 38 weeks from inclusion of the first patient
Sites Erasmus MC Rotterdam The Netherlands sponsor Hospital Clínic de Barcelona and Institut de Recerca de la Sida - Caixa Barcelona Spain Instituut voor Tropische Geneeskunde Antwerp Belgium and Vrije Universiteit BrusselUZ Brussel Belgium
Study population Chronically HIV-1- infected patients under stable cART with plasma viral load pVL 50 copiesml and stable CD4 T-cell counts 450μl aged 18 years or above
Sample size after recruitment and screening 70 patients will be included and randomized to one of the study-arms
Intervention One group n40 receives the HIVACAT-TriMix 300 microgram TriMix 900 microgram HIVACAT vaccine intranodally on three occasions with a two-week interval One control group n15 receives TriMix only 300 microgram TriMix and one group n15 receives saline intranodally on three occasions with a two-week interval Two weeks after the last vaccination cART treatment will be interrupted If plasma virus is detectable cART will be re-initiated twelve weeks after treatment interruption cART can always be re-initiated for medical reasons as judged by the clinical investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-002724-83 | EUDRACT_NUMBER | None | None |