AEGiS-15IAC: Cytolin is effective in reducing viral burden.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Cytolin is effective in reducing viral burden.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. B10073)

Northfelt DW, Allen A
Mayo Clinic Scottsdale, Scottsdale, United States

BACKGROUND: Cytolin® is an anti-LFA-1 monoclonal antibody (mAb) that may reversibly inhibit CD8+ CTL killing of CD4+ T cells; thus, reducing HIV viral load. Cytolin® has no effect on the virus - its method of action is to enhance immunocompetence; thus, evolution of virus subspecies has no effect on the efficacy of Cytolin®. Uncontrolled Clinical Setting: 188 AIDS patients (mean CD4 count = 177 cells/mm³) were treated with Cytolin® alone or in combination with standard anti-HIV therapy between 1993 and 1995. Patients received multiple doses of ~ 0.1 mg/kg body weight monthly or bimonthly for up to 27 months. Dose, dosing frequency, duration, and pre-medication decisions were at the discretion of the treating physician. No adverse events were serious. Anaphylactoid reactions were reported in 8 (4.3%) patients after 12 infusions (~ 1.8% of all transfusions). All reactions resolved with epinephrine and none were considered serious. Efficacy data for 48 patients for whom both a baseline measurement and at least one follow-up measurement were available show a mean reduction in viral load (0.3 log) that was the same in patients receiving Cytolin® as mono or combination therapy. Phase I Study: Cytolin® was studied in a Phase I single-dose study. In this study, 13 HIV-infected men (plasma HIV RNA concentrations >20,000 copies/mL, CD4+ T-cell counts 200-500 cells/mm³) were enrolled in 2 dose groups: 0.05 mg/kg (n=6) and 0.1 mg/kg (n=7). Preliminary efficacy assessment consisted of change from baseline in HIV viral load, CD4+ and CD8+ T-cell counts. In this study, Cytolin® was well tolerated. All AEs were mild to moderate. A single 0.1mg/kg dose reduced viral load 0.23 log and increased CD4+ and CD8+ T-cell counts (70.1cells/mm³ and 107.4 cell/mm³, respectively) at 56 days.

CONCLUSIONS: Cytolin® may be an important salvage drug for patients with resistant virus. Ongoing studies suggest multiple dosing at higher doses may be more effective in reducing HIV viral load.

Keywords: AEGIS, Viral Load, CD4 Lymphocyte Count, Antibodies, Monoclonal, HIV-1, Antigens, CD4, HIV Infections, Acquired Immunodeficiency Syndrome, Anti-HIV Agents, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, HIV Core Protein p24, HIV Protease Inhibitors, HIV, Antigens, CD8, HIV Protease, Disease Progression, HIV Seropositivity, Cytolin+, anti-LFA-1 monoclonal antibody, Humans, Male, immunology

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B10073