A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy

Inclusion Criteria

• •Documented history of HIV infection.
• •Age ≥ 18
• •Males and females are eligible. Subjects must agree to practice birth control or abstinence. Females of child-bearing potential must have a negative urine pregnancy within 14 days prior to study entry.
• •Adequate baseline organ function including the following laboratory values within 14 days prior to study entry:
• •Adequate liver function with ALT, AST and alkaline phosphatase ≤ 5 times upper limit of normal (ULN).
• •Total bilirubin ≤ 2.5 mg/dL Creatinine \< 2.3 Serum vitamin B12 level ≥ 200 pg/ml
• •Diagnosis of HIVM by a neurologist - defined as:
• •\- Presence of at least two of the following symptoms:
• •\- Paresthesias and/or numbness in the lower extremities or in all four limbs; Weakness of the limbs, with predominance in the lower extremities; Unsteady, stiff or uncoordinated gait; Sensation of electrical shock through the back or the legs upon flexion of the neck (L'Hermitte's sign); Stiffness or spasm in the lower extremities; Urinary frequency, urgency, incontinence or retention; Fecal incontinence or retention; Sexual dysfunction with erectile impairment in men;
• •\- Presence of at least two of the following neurologic signs:
• •\- Reduction in vibratory or position sensation in the lower extremities; Hyperactive deep tendon reflexes; Abnormal response to plantar stimulation (Babinski sign); Presence of L'Hermitte sign (electrical-type sensation down the back, provoked by flexion of the neck); Weakness in the lower extremities or in all four limbs; Spastic or ataxic gait
• •Antiretroviral regimen stable 2 months prior to the entry of the study.