It's time to approve more surrogate markers. Clearinghouse, AIDS Newsletter Database, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5714. A fee will apply. NLM AIDSLINE Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

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It's time to approve more surrogate markers. Clearinghouse, AIDS Newsletter Database, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5714. A fee will apply.

AIDS Treat News. 1997 Mar 21;(No 267):3-4. Unique Identifier : AIDSLINE AIDS/97702538
Scondras D

Abstract: Advances in AIDS treatments have led to nationwide declines in AIDS-related deaths, but the development of new therapies must continue. Because accepted markers for improved immune function are lacking, the further development of new therapies is stalled. Neither of the markers that are currently accepted, CD4 T-cell count and viral load, gives a complete picture of the immune system. The Food and Drug Administration (FDA) has addressed the need to evaluate new therapies using alternative immunological markers. A number of potential markers, including lymphocyte proliferation, cytokine levels, and delayed-type hypersensitivity reactions, seem highly correlated with disease progression. Research has shown that patients on antiviral therapy experience some immune restoration. These findings suggest that immune-based therapies may help the body to fight off damage to the immune system. However, no markers have been accepted by the FDA for immune restoration, restricting the development of such therapies.
Keywords: *Biological Markers CD4 Lymphocyte Count Disease Progression HIV Infections/*DRUG THERAPY/*IMMUNOLOGY Human Immune System/*DRUG EFFECTS/*PHYSIOLOGY RNA, Viral/BLOOD United States United States Food and Drug Administration Viral Load Virus Replication/PHYSIOLOGY NEWSLETTER ARTICLEKWDbiologicalmarkerscd4lymphocytecountdiseaseprogressionhivinfections/KWDdrugtherapy/KWDimmunologyhumanimmunesystem/KWDdrugeffects/KWDphysiologyrna,viral/bloodunitedstatesunitedstatesfoodanddrugadministrationviralloadvirusreplication/physiologynewsletterarticle
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