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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Genentech |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000663 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: CD4-IgG |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
Official Title: | A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection |
Estimated Enrollment: | 18 |
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.
Ages Eligible for Study: | up to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded for a minimum of 3 weeks prior to study entry:
Risk Behavior:
Excluded:
United States, California | |
UCSD Treatment Ctr | |
San Diego, California, United States, 92103 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
United States, New York | |
North Shore Univ Hosp | |
Great Neck, New York, United States, 11021 | |
Columbia Univ Babies' Hosp | |
New York, New York, United States, 10032 | |
United States, Texas | |
Texas Children's Hosp / Baylor Univ | |
Houston, Texas, United States, 77030 |
Study Chair: | R Yogev | |
Study Chair: | W Shearer |
Study ID Numbers: | ACTG 139, D0172g |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000663 |
Health Authority: | United States: Federal Government |
Recombinant Proteins Injections, Intravenous IgG Drug Evaluation |
Acquired Immunodeficiency Syndrome Antigens, CD4 Carrier Proteins |
Virus Diseases Antibodies Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Immunoglobulin G CD4 Immunoadhesins Retroviridae Infections Immunologic Deficiency Syndromes Immunoglobulins |
Communicable Diseases RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Lentivirus Infections Infection Pharmacologic Actions |