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Shot in the Dark

Against the Odds, Immune-Based Therapies for HIV Slog Along

February 2004

A note from The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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Blocking the "Bad" Interleukins: Anti-IL-4 and IL-13

Another IBT strategy involves blocking potentially harmful cytokines. A small biotech company called Regeneron is developing a product called IL-4/IL-13 Trap based on the idea that these cytokines inhibit virus-specific CD8 T-cell responses. Results from a phase I dose-ranging trial in HIV-negative volunteers were presented at the 2004 Retrovirus conference, showing that the construct was well tolerated with a long half-life of 13 days. Further studies in HIV-infected individuals are planned.

Glaxo Dusts Off Something for APCs

Tucaresol is a relatively obscure IBT candidate that has languished in GlaxoSmithKline's HIV drug portfolio since the early 1990s. The drug appears to enhance interactions between antigen-presenting cells and T cells and has been shown to boost cell-mediated immune responses both in mice and in humans. Preliminary data from a phase I trial in 17 HIV-infected individuals were presented at the 2004 Retrovirus conference, demonstrating increases in naive CD4 T-cell counts and the number of T cells containing TRECs (a potential marker for T cells recently produced by the thymus) in the group of participants receiving HAART treatment. Larger studies are now likely.

Two That Target Defective Cellular "Signaling"

Two experimental IBTs aim to influence T-cell function by interacting with signaling molecules on the T-cell surface. One such molecule is CTLA-4, which is upregulated on T cells in HIV infection and associated with the induction of T-cell unresponsiveness or anergy. In June of 2003, the biotech company Medarex launched a phase I trial of an anti-CTLA-4 antibody dubbed MDX-010 in heavily treatment experienced HIV-infected individuals that are failing HAART, with the aim of blocking the suppressive activity of CTLA-4 and thus improving HIV-specific immunity. Results from this study have not yet been presented. Another molecule that is a target for IBTs is CD40. Signaling via CD40 is triggered by CD40 ligand (CD40L) and can potentially enhance the function of otherwise lethargic virus-specific CD8 T cells. The rights to CD40L were held by Immunex, a company that was recently bought by Amgen. The current developmental status of CD40L is unclear as Amgen did not return calls prior to going to press.

IBTs in Development

Information on IBT in development is ever-changing. If you know of any inaccuracies in -- or omissions from -- this list, please send an e-mail to


Cytokines and Immunomodulators
interleukin-2 (IL-2)ChironPhase III
BAY 50-4798BayerPhase I/II
interleukin-7 (IL-7)Biotech Inflection PointPreclinical
Interleukin-15 (IL-15)Amgen (formerly Immunex)Preclinical
IL-4/IL-13 trapRegeneron PharmaceuticalsPhase I
Serostim (human growth hormone)SeronoPhase not specified (ACTG 5174)
TucaresolGlaxoSmithKlinePhase I
MDX-010 anti-CTLA4 antibodyMedarexPhase I
Avrend (CD40 ligand)Amgen (formerly Immunex)?
Pegasys (peginterferon alfa-2a)Roche PharmaceuticalsPhase IB/II
HE2000Hollis EdenPhase II

Therapeutic Vaccines
ALVAC (vCP1452)Aventis PasteurPhase II
LipopeptidesAventis Pasteur/ANRSPhase II
DermavirResearch Institute for Genetic & Human Therapy (RIGHT)Pre-clinical
VRC-HIVDNA009-00-VP Gag/Pol/Nef/multiclade Envs (A, B, C)VRC/NIAIDPhase I
MVA-BN-NefBavarian NordicPhase I
MVA-mBN32Bavarian Nordic/EpimmunePhase I
MRKAd5MerckPhase I/II
MRKDNAMerckPhase I
VEE repliconAlphaVaxPhase I in HIV seronegative volunteers
Autologous dendritic cells pulsed w/ALVACACTG/AventisPhase I
Autologous dendritic cell HIV vaccination w/conserved HIV-derived peptidesUniversity of PittsburghPhase I
Multi-epitope DNAEpimmunePhase I
DNA + IL-12 or IL-15Wyeth-AyerstPre-clinical
Whole-killed (pseudovirions)Kathy Grovit-Ferbas/UCLAPre-clinical
Tat/Nef/gp120 in ASO2A adjuvantGlaxoSmithKlinePre-clinical
DNA/MVACobra Pharmaceuticals, Impfstoffwerk Dessau-Tornau GmbH (IDT), Oxford University/MRCPhase I/II
RemuneImmune Response CorporationFailed phase III, remains under investigation in context of STIs
Tat vaccineAventis PasteurPhase I
DNA/fowlpox prime-boostViraxPhase I
Synthetic peptide immunogensUnited BiomedicalPre-clinical
HIV L.E.A.P.S. HIV-1 p17 constructs (L.E.A.P.S. 101B, 101C, 102B and 102C)Cel-SciPre-clinical

Gene Therapies
VRX496 lentiviral vectorVIRxSYSPhase I
Ribozymes (RRz2)Johnson & JohnsonPhase II
HGTV43Enzo BiochemPhase I
CD4 T cells transduced with M87o viral entry inhibitorEUFETS AGPhase I
CD4zeta modified CD4 and CD8 T cellsCell GenesysPhase II

Cellular Therapies
Activated Cellular Therapy (ACT)NeoprobeOn hold pending identification of a development partner

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A note from The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

This article was provided by Treatment Action Group. It is a part of the publication TAGline.
See Also
More on Immune-Based Therapies: Basics