A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

HIV Infections Clinical Trial

Official title:

A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000827
• Other study ID #: ACTG 273
• Secondary ID: 11249
• Status: Completed
• Phase: Phase 1
• Est. completion date: April 1998

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.

Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

Description:

Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria

Concurrent Medication:

Required:

• PCP prophylaxis according to CDC guidelines.

Allowed:

• Varicella-zoster immunoglobulin.

• Hepatitis B immunoglobulin.

• Prophylactic therapies not involving immunoglobulin.

Patients must have:

• HIV infection.

• CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years).

• Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry.

• Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry.

• Life expectancy of at least 6 months.

Prior Medication: Required:

• Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG.

• Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia).

• Acute illness with temperature >= 100 F and/or with IV antibiotics.

• Grade 3 or worse clinical toxicities.

• Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min.

• Concomitant participation in an experimental antiretroviral or HIV vaccine trial.

Concurrent Medication:

Excluded:

• IVIG.

• Chemotherapy for an active malignancy.

• MMR or rubella vaccinations.

• Intramuscular immunoglobulin.

Patients with the following prior condition are excluded:

• History of severe reaction to IVIG.

Prior Medication:

Excluded:

• IVIG within the past 60 days.

• Chemotherapy for an active malignancy within the past year.

• MMR or rubella vaccinations within the past 6 months.

• Intramuscular immunoglobulin within the past 60 days.

Ongoing drug or alcohol abuse.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Anti-HIV Immune Serum Globulin (Human)

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hosp. PR NICHD CRS	San Juan
Puerto Rico	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan
United States	Children's Hospital at Albany Medical Center, Dept. of Peds.	Albany	New York
United States	Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Atlanta	Georgia
United States	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado
United States	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland
United States	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland
United States	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama
United States	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts
United States	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts
United States	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York
United States	Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases	Charleston	South Carolina
United States	Children's Med. Ctr. Dallas	Dallas	Texas
United States	Children's Hospital of Michigan NICHD CRS	Detroit	Michigan
United States	Univ. of Connecticut Health Ctr., Dept. of Ped.	Farmington	Connecticut
United States	North Shore-Long Island Jewish Health System, Dept. of Peds.	Great Neck	New York
United States	Texas Children's Hosp. CRS	Houston	Texas
United States	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida
United States	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California
United States	Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy	Los Angeles	California
United States	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS	Los Angeles	California
United States	Usc La Nichd Crs	Los Angeles	California
United States	St. Jude/UTHSC CRS	Memphis	Tennessee
United States	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida
United States	Columbia IMPAACT CRS	New York	New York
United States	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York
United States	Incarnation Children's Ctr.	New York	New York
United States	NYU Med. Ctr., Dept. of Medicine	New York	New York
United States	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California
United States	St. Joseph's Hosp. & Med. Ctr. of New Jersey	Paterson	New Jersey
United States	The Children's Hosp. of Philadelphia IMPAACT CRS	Philadelphia	Pennsylvania
United States	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York
United States	UCSF Pediatric AIDS CRS	San Francisco	California
United States	UW School of Medicine - CHRMC	Seattle	Washington
United States	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts
United States	SUNY Stony Brook NICHD CRS	Stony Brook	New York
United States	Children's National Med. Ctr., ACTU	Washington	District of Columbia
United States	Howard Univ. Washington DC NICHD CRS	Washington	District of Columbia
United States	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	North American Biologicals Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Stiehm ER, Fletcher CV, Mofenson LM, Palumbo PE, Kang M, Fenton T, Sapan CV, Meyer WA, Shearer WT, Hawkins E, Fowler MG, Bouquin P, Purdue L, Sloand EM, Nemo GJ, Wara D, Bryson YJ, Starr SE, Petru A, Burchett S. Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS clinical trials group protocol 273). J Infect Dis. 2000 Feb;181(2):548-54. — View Citation