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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000827

Collaborator

North American Biologicals Inc (Industry)

Enrollment

Locations

1.2

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Anti-HIV Immune Serum Globulin (Human)	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Apr 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama	United States	35294
2	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California	United States	90801
3	Usc La Nichd Crs	Los Angeles	California	United States	90033
4	Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy	Los Angeles	California	United States
5	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS	Los Angeles	California	United States
6	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California	United States
7	UCSF Pediatric AIDS CRS	San Francisco	California	United States
8	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado	United States
9	Univ. of Connecticut Health Ctr., Dept. of Ped.	Farmington	Connecticut	United States	06030
10	Howard Univ. Washington DC NICHD CRS	Washington	District of Columbia	United States	20060
11	Children's National Med. Ctr., ACTU	Washington	District of Columbia	United States
12	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida	United States	32209
13	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida	United States	33161
14	Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Atlanta	Georgia	United States	30306
15	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland	United States	21201
16	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland	United States
17	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts	United States
18	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts	United States
19	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts	United States	01199
20	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts	United States
21	Children's Hospital of Michigan NICHD CRS	Detroit	Michigan	United States	48201
22	St. Joseph's Hosp. & Med. Ctr. of New Jersey	Paterson	New Jersey	United States
23	Children's Hospital at Albany Medical Center, Dept. of Peds.	Albany	New York	United States	12208
24	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York	United States
25	North Shore-Long Island Jewish Health System, Dept. of Peds.	Great Neck	New York	United States	11021
26	Columbia IMPAACT CRS	New York	New York	United States	10032
27	Incarnation Children's Ctr.	New York	New York	United States	10032
28	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York	United States	10037
29	NYU Med. Ctr., Dept. of Medicine	New York	New York	United States
30	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York	United States
31	SUNY Stony Brook NICHD CRS	Stony Brook	New York	United States
32	The Children's Hosp. of Philadelphia IMPAACT CRS	Philadelphia	Pennsylvania	United States	19104
33	Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases	Charleston	South Carolina	United States	29425
34	St. Jude/UTHSC CRS	Memphis	Tennessee	United States
35	Children's Med. Ctr. Dallas	Dallas	Texas	United States	75235
36	Texas Children's Hosp. CRS	Houston	Texas	United States	77030
37	UW School of Medicine - CHRMC	Seattle	Washington	United States
38	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico
39	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan		Puerto Rico