Trial intelligence / Profile preview

SPARC-7: Multi-Intervention for HIV Cure

NCT02961829Phase 2

Key facts

Status: Completed
Start: Jul 2015
Primary completion: Mar 2019
Countries: 1
Sponsor: Federal University of São Paulo
Modality: Whole Cell Cancer Vaccines, Dendritic Cell Vaccines, Small Molecules

Drugs: maravirocdolutegravirnicotinamideauranofinWT1/hTERT/Survivin-loaded dendritic cell vaccine
Conditions: human immunodeficiency virus infection (HIV)

Overview

Phase 2, randomised, open-label trial of maraviroc, dolutegravir, nicotinamide, auranofin and WT1/hTERT/Survivin-loaded dendritic cell vaccine in human immunodeficiency virus infection (HIV) (6 arms), sponsored by Federal University of São Paulo. Primary endpoints: Ultrasensitive RNA Viral load at 48 weeks, Cell-associated HIV RNA at 48 weeks and 4 more. Started Jul 2015; status: completed.

Design

6 arms

Study design: RandomizedOpen-label

Control
No additional intervention (Background ART only)
ART Intensification
Maraviroc + Dolutegravir
ART Intensification + Nicotinamide
Maraviroc + Dolutegravir + Nicotinamide
ART Intensification + Auranofin
Maraviroc + Dolutegravir + Auranofin (24 weeks)
ART Intensification + DC Vaccine
Dolutegravir + DC Vaccine
Multi Interventional
Dolutegravir + Nicotinamide + Auranofin (24 weeks) + DC Vaccine

Endpoints

Primary

Ultrasensitive RNA Viral load48 weeks
Cell-associated HIV RNA48 weeks
Episomal DNA48 weeks
Specific HIV antibodies48 weeks
CD38 and HLA-DR on CD4 and CD8+ cells48 weeks

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