Completed

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

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What is being tested

CD4-IgG

Drug
Who is being recruted

HIV Infections

Until 5 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
18 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 5 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria 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. Exclusion Criteria 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: Excluded: * Patients born to substance abusing mothers (including alcohol) during the pregnancy.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 7 locations
Suspended
UCSD Treatment CtrSan Diego, United StatesSee the location
Suspended
Univ of Miami School of MedicineMiami, United States
Suspended
Cook County HospChicago, United States
Suspended
Tulane Univ Med SchoolNew Orleans, United States

Completed7 Study Centers