To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain preliminary indication of the antiviral and immunologic effects of recombinant CD4 immunoglobulin G (CD4-IgG). CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date.
CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date. Patients receive one intravenous injection the first week, followed by a 6 day washout period and then intravenous injections on a twice weekly basis from week 2 to week 12. The dose per injection may vary. The study evaluates 2 groups: (1) Children 3 months to 5 years of age; (2) Infants 0-3 months of age.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
18
UCSD Treatment Ctr
San Diego, California, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Cook County Hosp
Chicago, Illinois, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
North Shore Univ Hosp
Great Neck, New York, United States
Columbia Univ Babies' Hosp
New York, New York, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
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