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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
This study has been completed.
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Genentech
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000663
  Purpose

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
HIV Infections
Drug: CD4-IgG
Phase I

MedlinePlus related topics: AIDS
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 18
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000663

Locations
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
Sponsors and Collaborators
Genentech
Investigators
Study Chair: R Yogev
Study Chair: W Shearer
  More Information

Publications:
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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Recombinant Proteins
Injections, Intravenous
IgG
Drug Evaluation
Acquired Immunodeficiency Syndrome
Antigens, CD4
Carrier Proteins

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009