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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000663

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

18

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have the following:
• HIV-1 infection, or if less than 15 months old, born to mother with HIV-1 infection.
• Legally qualified guardian with the ability to sign a written, informed consent form.
• Willingness to abstain from all other experimental therapy for HIV-1 infection during the first 12 weeks of the study period.
• Anticipated life expectancy of at least 3 months.
• Prior Medication:
• Allowed:
• Prophylactic anti-Pneumocystis carinii pneumonia (PCP) or antifungal therapy.
• Gamma globulin as prophylaxis for measles and varicella.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Past or present history of neurological abnormalities including withdrawal syndrome or seizures.
• Past or present history of any serious active opportunistic infection including Pneumocystis carinii pneumonia (PCP).
• Echocardiogram values > 2 standard deviations from normal.
• Hematologic, renal, or hepatic insufficiency.
• Concurrent Medication:
• Excluded:
• Zidovudine (AZT).
• Intravenous gamma globulin (IVIG) except as prophylaxis for measles and varicella.
• Cancer chemotherapy.
• Corticosteroids.
• Other known immunomodulatory agents.
• Other experimental therapy not specifically allowed.
• Patients with the following are excluded:
• Hematologic, renal, or hepatic insufficiency.
• Past or present history of any serious active opportunistic infection.
• Prior Medication:
• Excluded for a minimum of 3 weeks prior to study entry:
• Zidovudine (AZT).
• Intravenous gamma globulin (IVIG).
• Cancer chemotherapy.
• Immunomodulatory agents.
• Acyclovir and other experimental therapy.
• Risk Behavior:

Where it is running

• 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

Full record on ClinicalTrials.gov

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