A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
Condition: HIV-associated Myelopathy
MeSH terms: Spinal Cord Diseases; Bone Marrow Diseases
Intervention: Intravenous Immunoglobulin; Placebo
Intervention description: Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®; Placebo - 2gr/kg over 2 days of saline
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV associated myelopathy

Summary:

      The purpose of this study is to determine whether Intravenous Immunoglobulin (IVIG) is an
      effective treatment for HIV associated myelopathy.
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          -  Presence of acute, active, opportunistic infection, except oral thrush, orogenital or
             rectal herpes and MAI bacteremia within 2 weeks before randomization.

          -  Evidence of another contributing cause for myelopathy.

          -  Women who are pregnant, breast-feeding or planning a pregnancy.

          -  Active abuse of drugs or alcohol, which in the opinion of the investigator would
             interfere with the subject's ability to comply with the protocol.

          -  Any neurologic or systemic conditions, which in the opinion of the investigator would
             interfere with the evaluation of the subject.

          -  Presence of significant cardiac, pulmonary or renal disease that would place the
             subject at risk for the fluid and protein load of IVIg.

          -  History of hypersensitivity to immunoglobulin, or IgA deficiency; Vaccination with
             live viruses within the past 90 days; Patients receiving IVIg or other
             immunomodulatory agent (cyclosphosphamide, azathioprine, corticosteroids, tacrolimus,
             cyclosporine, OKT3, plasma exchange, alpha, beta or gamma interferon) within the past
             3 months.

          -  Patients in whom muscle dynamometry can not be performed for any reason.