Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS Clinical Trials Group Protocol 273)

E. Richard Stiehm; Courtney V. Fletcher; Lynne M. Mofenson; Paul E. Palumbo; Minhee Kang; Terry Fenton; Christine V. Sapan; William A. Meyer; William T. Shearer; Elizabeth Hawkins; Mary Glenn Fowler; Pamela Bouquin; Lynette Purdue; Elaine M. Sloand; George J. Nemo; Diane Wara; Yvonne J. Bryson; Stuart E. Starr; Ann Petru; Sandra Burchett

doi:10.1086/315224

Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS Clinical Trials Group Protocol 273)

E. Richard Stiehm, Courtney V. Fletcher, Lynne M. Mofenson, Paul E. Palumbo, Minhee Kang, Terry Fenton, Christine V. Sapan, William A. Meyer, William T. Shearer, Elizabeth Hawkins, Mary Glenn Fowler, Pamela Bouquin, Lynette Purdue, Elaine M. Sloand, George J. Nemo, Diane Wara, Yvonne J. Bryson, Stuart E. Starr, Ann Petru, Sandra Burchett

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Abstract

The clinical, immunologic, and virologic effects and the pharmacokinetics of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2-11 years. All had moderately advanced disease with an immune complex- dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and serial immunologic and virologic assays were performed. HIVIG doses as high as 800 mg/kg were safe and well tolerated. The half-life of HIVIG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 mL/kg, and clearance was 5.6- 6.0 mL/kg/day. Plasma ICD p24 decreased during the infusions, but CD4 cell levels, plasma RNA copy number, cellular virus, immunoglobulin levels, and neutralizing antibody titers were minimally affected by the infusions. Clinical status did not change during the 6-month infusion and 3-month follow-up periods.

Original language	English (US)
Pages (from-to)	548-554
Number of pages	7
Journal	Journal of Infectious Diseases
Volume	181
Issue number	2
DOIs	https://doi.org/10.1086/315224
State	Published - 2000
Externally published	Yes

ASJC Scopus subject areas

General Medicine

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10.1086/315224

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Stiehm, E. R., Fletcher, C. V., Mofenson, L. M., Palumbo, P. E., Kang, M., Fenton, T., Sapan, C. V., Meyer, W. A., Shearer, W. T., Hawkins, E., Fowler, M. G., Bouquin, P., Purdue, L., Sloand, E. M., Nemo, G. J., Wara, D., Bryson, Y. J., Starr, S. E., Petru, A., & Burchett, S. (2000). Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS Clinical Trials Group Protocol 273). Journal of Infectious Diseases, 181(2), 548-554. https://doi.org/10.1086/315224

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 2000, 'Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS Clinical Trials Group Protocol 273)', Journal of Infectious Diseases, vol. 181, no. 2, pp. 548-554. https://doi.org/10.1086/315224

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title = "Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS Clinical Trials Group Protocol 273)",

abstract = "The clinical, immunologic, and virologic effects and the pharmacokinetics of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2-11 years. All had moderately advanced disease with an immune complex- dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and serial immunologic and virologic assays were performed. HIVIG doses as high as 800 mg/kg were safe and well tolerated. The half-life of HIVIG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 mL/kg, and clearance was 5.6- 6.0 mL/kg/day. Plasma ICD p24 decreased during the infusions, but CD4 cell levels, plasma RNA copy number, cellular virus, immunoglobulin levels, and neutralizing antibody titers were minimally affected by the infusions. Clinical status did not change during the 6-month infusion and 3-month follow-up periods.",

author = "Stiehm, {E. Richard} and Fletcher, {Courtney V.} and Mofenson, {Lynne M.} and Palumbo, {Paul E.} and Minhee Kang and Terry Fenton and Sapan, {Christine V.} and Meyer, {William A.} and Shearer, {William T.} and Elizabeth Hawkins and Fowler, {Mary Glenn} and Pamela Bouquin and Lynette Purdue and Sloand, {Elaine M.} and Nemo, {George J.} and Diane Wara and Bryson, {Yvonne J.} and Starr, {Stuart E.} and Ann Petru and Sandra Burchett",

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doi = "10.1086/315224",

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pages = "548--554",

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AU - Palumbo, Paul E.

AU - Kang, Minhee

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AU - Sapan, Christine V.

AU - Meyer, William A.

AU - Shearer, William T.

AU - Hawkins, Elizabeth

AU - Fowler, Mary Glenn

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AU - Purdue, Lynette

AU - Sloand, Elaine M.

AU - Nemo, George J.

AU - Wara, Diane

AU - Bryson, Yvonne J.

AU - Starr, Stuart E.

AU - Petru, Ann

AU - Burchett, Sandra

PY - 2000

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N2 - The clinical, immunologic, and virologic effects and the pharmacokinetics of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2-11 years. All had moderately advanced disease with an immune complex- dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and serial immunologic and virologic assays were performed. HIVIG doses as high as 800 mg/kg were safe and well tolerated. The half-life of HIVIG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 mL/kg, and clearance was 5.6- 6.0 mL/kg/day. Plasma ICD p24 decreased during the infusions, but CD4 cell levels, plasma RNA copy number, cellular virus, immunoglobulin levels, and neutralizing antibody titers were minimally affected by the infusions. Clinical status did not change during the 6-month infusion and 3-month follow-up periods.

AB - The clinical, immunologic, and virologic effects and the pharmacokinetics of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin (HIVIG) were assessed in 30 HIV-infected children aged 2-11 years. All had moderately advanced disease with an immune complex- dissociated (ICD) p24 antigen >70 pg/mL and were on stable antiviral therapy. Three groups of 10 children received 6 monthly infusions of 200, 400, or 800 mg/kg of HIVIG, and serial immunologic and virologic assays were performed. HIVIG doses as high as 800 mg/kg were safe and well tolerated. The half-life of HIVIG, determined by serial p24 antibody titers, was 13-16 days, the volume of distribution was 102-113 mL/kg, and clearance was 5.6- 6.0 mL/kg/day. Plasma ICD p24 decreased during the infusions, but CD4 cell levels, plasma RNA copy number, cellular virus, immunoglobulin levels, and neutralizing antibody titers were minimally affected by the infusions. Clinical status did not change during the 6-month infusion and 3-month follow-up periods.

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Use of human immunodeficiency virus (HIV) human hyperimmune immunoglobulin in HIV type 1-infected children (Pediatric AIDS Clinical Trials Group Protocol 273)

Abstract

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