iHIVARNA Clinical Trial in HIV Infected Individuals

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, i.e. controlling viral replication in the absence of anti-retroviral therapy.

Timeline

Start

2017-04-04

Primary completion

2018-02-12

Completion

2018-02-12

Outcome

Missed primary endpoint

Stopped: “Interim analysis did not show sufficient immunogenicity of IMP compared to placebo”

registry analysis (superiority test); iHIVARNA-01 vs TriMix vs Placebo; p = 0.14; Mixed Models Analysis NCT02888756 ↗

Publications

• de Jong W, Aerts J, Allard S, Brander C, Buyze J, Florence E, van Gorp E, Vanham G, Leal L, Mothe B, Thielemans K, Plana M, Garcia F, Gruters R; iHIVARNA consortium. iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy. Trials. 2019 Jun 17;20(1):361. doi: 10.1186/s13063-019-3409-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TriMix	Messenger RNA (mRNA)	300 ug	Other
Subject	iHIVARNA-01	Unknown	1200 ug	Other

Indications