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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000663
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Allergy and Infectious Diseases (NIAID)
Genentech, Inc.
Investigators
Study Chair: R Yogev
Study Chair: W Shearer
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000663     History of Changes
Other Study ID Numbers: ACTG 139
D0172g
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: October 1996

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulin G
CD4 Immunoadhesins
Immunologic Factors
Physiological Effects of Drugs