Ahrendt LD, Witek J, Dean LM, Sigler AJ, Blumberg EA, Wood CA, Molavi A, Mastoridis P, Affrime MB, Cutler DL, Gold MJ, Fuchs AC; Conference on Retroviruses and Opportunistic Infections.

Program Abstr 5th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 5th 1998 Chic Ill. 1998 Feb 1-5; 5th: 195 (abstract no. 613).

Allegheny University Hospitals, Philadelphia, PA.

In vitro, IL- 10 inhibits reverse transcriptase activity, prevents TNF-alpha-induced HIV replication, and inhibits the early steps of HIV infection. One dose of intravenous (IV) IL-10 was associated with a rapid reduction in HIV viral load in a single open-label study. We conducted a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and effects on HIV viral load of a single injection of IL-10. Thirty five HIV-infected patients with CD4 cell counts greater than 200/ml received a single injection of IL-10 (1 microgram/kg IV or 0.25, 1, 8, or 20 micrograms/kg SC) or placebo (IV or SC). Safety parameters, HIV viral load, CD4 counts, and circulating chemokine levels were assessed before and 3, 6, 12, 18 and 24 hours after the injection and daily on Days 3-8. IL-10 was well tolerated in this patient population. Only 1 patient developed a serious adverse reaction that was possibly drug-related (fever). 30-65% of IL-10 recipients had a decrease in viral load of greater than 0.5 log during the one-week study period. This was not significantly different from placebo recipients. 3 of 30 (10%) IL-10-treated patients and 1 of 5 (20%) placebo-treated patients had a greater than 0.5 log increase in viral load during the study. These increases occurred at least 5 days after the injection in all 4 patients. There was a mild transient decrease in the CD4 cell count (20-40%) 3-6 hours following administration of both IL-10 and placebo. There were no significant changes in circulating MIP-lalpha, IL-6, or TNF-alpha. IL-10 was safe and well tolerated in asymptomatic HIV positive patients with CD4 counts greater than 200/ml. Unlike the previous study, this pilot study did not demonstrate a significant antiviral effect of single-dose IL-10 but given its vitro actions, further study of multiple-dose IL-10 is warranted.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS Vaccines
• Acquired Immunodeficiency Syndrome
• Antiviral Agents
• CD4 Lymphocyte Count
• Clinical Trials, Phase I as Topic
• HIV Infections
• HIV Seropositivity
• Humans
• In Vitro
• Interleukin-10
• Interleukin-6
• Single Person
• Viral Load

Other ID:

• 98929545

UI: 102236198

From Meeting Abstracts