Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir

Phase 2 Completed 28 enrolled Robert L. Murphy Merck Sharp & Dohme LLC · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab Objectif Recherche Vaccins SIDA · collab Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to discover a new approach in which human immunodeficiency virus (HIV) can be eradicated from an infected individual by intensified antiretroviral treatment coupled with immunomodulation. The hypothesis is that eradication is possible only if very potent antiretroviral drugs are delivered in conjunction with an immunomodulatory agent that simultaneously attack the viral reservoirs.

Timeline

Start: 2009-11
Primary completion: 2013-07
Completion: 2014-06

Publications

Achenbach CJ, Assoumou L, Deeks SG, Wilkin TJ, Berzins B, Casazza JP, Lambert-Niclot S, Koup RA, Costagliola D, Calvez V, Katlama C, Autran B, Murphy RL; EraMune 02 study team. Effect of therapeutic intensification followed by HIV DNA prime and rAd5 boost vaccination on HIV-specific immunity and HIV reservoir (EraMune 02): a multicentre randomised clinical trial. Lancet HIV. 2015 Mar;2(3):e82-91. doi: 10.1016/S2352-3018(15)00026-0. Epub 2015 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Maraviroc	Other / unclassified	150 mg	Oral
Subject	Maraviroc	Other / unclassified	300 mg	Oral
Subject	Maraviroc	Other / unclassified	600 mg	Oral
Subject	Raltegravir	Other / unclassified	400 mg	Oral
Subject	VRC-HIVADV014-00-VP	Vaccine	1e+10 unknown	Subcutaneous
Subject	VRC-HIVDNA016-00-VP	Vaccine	4 mg	Subcutaneous

Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir

Summary

Timeline

Publications

Drugs

Indications