Status:

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Genentech, Inc.

Conditions:

HIV Infections

Eligibility:

All Genders

1-5 years

Phase:

PHASE1

Brief Summary

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-I...

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 c...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT00000663

Last Update

June 24 2005

Active Locations (7)

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Page 1 of 2 (7 locations)

1

UCSD Treatment Ctr

San Diego, California, United States, 92103

2

Univ of Miami School of Medicine

Miami, Florida, United States, 33136

3

Cook County Hosp

Chicago, Illinois, United States, 60612

4

Tulane Univ Med School

New Orleans, Louisiana, United States, 70112

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 | DecenTrialz