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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000663
• Other study ID #: ACTG 139
• Secondary ID: D0172g
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: October 1996
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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-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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection

Intervention

Drug:
• CD4-IgG

Locations

Country	Name	City	State
United States	Cook County Hosp	Chicago	Illinois
United States	North Shore Univ Hosp	Great Neck	New York
United States	Texas Children's Hosp / Baylor Univ	Houston	Texas
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Columbia Univ Babies' Hosp	New York	New York
United States	UCSD Treatment Ctr	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Shearer WT, Israel RJ, Starr S, Fletcher CV, Wara D, Rathore M, Church J, DeVille J, Fenton T, Graham B, Samson P, Staprans S, McNamara J, Moye J, Maddon PJ, Olson WC. Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team. J Infect Dis. 2000 Dec;182(6):1774-9. Epub 2000 Oct 27. — View Citation

Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)