Completed

Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G in HIV-1 Infected Infants and Children

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What is being tested

CD4-IgG

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

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

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.

NCT00000663
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 enrolled

Total 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 sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

6 inclusion criteria required to participate
Anticipated life expectancy of at least 3 months
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
Show More Criteria
16 exclusion criteria prevent from participating
Cancer chemotherapy
Corticosteroids
Echocardiogram values > 2 standard deviations from normal
Hematologic, renal, or hepatic insufficiency
Show More Criteria

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

UCSD Treatment Ctr

San Diego, United StatesOpen UCSD Treatment Ctr in Google Maps

Univ of Miami School of Medicine

Miami, United States

Cook County Hosp

Chicago, United States

Tulane Univ Med School

New Orleans, United States
Completed7 Study Centers