AEGiS-14IAC: A phase IIB prospective, randomized, controlled study evaluating the immunomodulatory role of poly I:poly C12U against HIV.

14th International AIDS Conference


Barcelona, Spain - July 7-12, 2002

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A phase IIB prospective, randomized, controlled study evaluating the immunomodulatory role of poly I:poly C12U against HIV.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPeB9010)

Strayer D, Blick G, Mitchell W, Cimoch P, Carter W
Hemispherx Biopharma, Inc., Philadelphia, United States

BACKGROUND: Prolonged use of highly active antiretroviral therapy (HAART) has been associated with long term, potentially fatal, toxicities. Structured treatment interruption (STI) of HAART in chronically HIV-infected individuals to augment protective Th1 immune responses in order to achieve prolonged control of HIV-1 viremia has proved disappointing. Poly I:poly C12U, a specifically designed dsRNA molecule, is a biological response modifier with anti-HIV activity and strong Th1 immunomodulatory properties that has been shown to augment delayed-type hypersensitivity (DTH) responses in HIV disease and may delay rebound of HIV during STI of HAART.

METHOD: In this Phase IIB prospective, randomized controlled study, individuals with HIV RNA (PCR) <50c/ml and CD4>400 are randomized 1:1 to undergo up to three STIs with poly I:poly C12U (400 mg IV twice weekly) or without (CONTROL). STI is discontinued when PCR rebounds >5000 c/ml for three consecutive weekly determinations or >50,000 c/ml once.

RESULTS: After a median duration of 9+ months, CONTROL patients (n=6) have undergone STI#1 for a median duration of 7 weeks (mean 13+ weeks), while STI#1 in poly I:poly C12U patients (n=4) has been significantly (p<0.05) prolonged to a median 25+ weeks (mean 25+ weeks). Adverse events with poly I:poly C12U have been mild and self-limiting, and no adverse effects on lactic acid, insulin resistance, or hyperlipidemia have been observed.

CONCLUSIONS: Initial results demonstrate that poly I:poly C12U is well tolerated and may significantly prolong the duration of controlled HIV-1 viremia during STI of HAART.

Keywords: AEGIS, HIV, HIV Infections, Antiretroviral Therapy, Highly Active, HIV-1, Poly I, Anti-HIV Agents, HIV Seropositivity, Viremia, Antigens, CD4, HIV Protease Inhibitors, HIV Antibodies, Human, immunologyKWDaegis,hiv,hivinfections,antiretroviraltherapy,highlyactive,hiv-1,polyi,anti-hivagents,hivseropositivity,viremia,antigens,cd4,hivproteaseinhibitors,hivantibodies,human,immunology

020707
LbPeB9010

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.