A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine

NCT00000720 | Completed Phase 3

• 2 other identifiers: ACTG 05111025
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 51

Brief Summary

To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.

Conditions

HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Placebos; Infusions, Intravenous; Gamma-Globulins; Combined Modality Therapy; Acquired Immunodeficiency Syndrome; Zidovudine; Bacterial Infections; Immunization, Passive

Interventions

Globulin, Immune DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Benadryl and/or acetaminophen may be given before and during intravenous immunoglobulin (IVIG) infusion in patients demonstrating mild reactions during infusion.
• Acetaminophen for short-term fever and pain.
• Zidovudine (AZT).
• Steroids.
• Oral or systemic (swish and swallow) nystatin.
• Maintenance therapy for fungal disease or tuberculosis.
• Prophylaxis for a previous episode of Pneumocystis carinii pneumonia (PCP) including the use of trimethoprim / sulfamethoxazole (TMP / SMX). The dosage is specified as TMP 75 mg/m2 twice daily 3 times a week and SMX 375 mg/m2 twice daily 3 times a week.
• Recommended:
• Children with AIDS and / or CD4 count = or \< 500 cells/mm3 should receive primary PCP prophylaxis as described.
• Concurrent Treatment:
• Allowed:
• Blood transfusion for hemoglobin \< 8 g/dl and hematocrit \< 24 percent or bone marrow suppression.
• Supplemental oxygen with a prestudy PaO2 \< 70 mmHg.

You may not qualify if:

• Co-existing Condition:
• Patients with the following will be excluded:
• Lymphoid interstitial proliferation (LIP) not requiring steroids and supplemental oxygen or with other lymphoproliferative diseases as their sole clinical evidence of HIV infection.
• Known hypersensitivity to immunoglobulin.
• Active HIV thrombocytopenia requiring IVIG therapy.
• Concurrent Medication:
• Excluded:
• Chronic acetaminophen.
• Drugs that are metabolized by hepatic glucuronidation should not be used for more than 24 hours without notifying the study physician.
• Antibacterial prophylaxis for otitis, sinusitis, or urinary tract infection.
• Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP) prior to the first episode of laboratory-documented PCP.
• Immunoglobulin (IVIG) therapy required for active HIV thrombocytopenia.
• Patients with the following will be excluded:
• Lymphoid interstitial proliferation (LIP) not requiring steroids and supplemental oxygen or with other lymphoproliferative diseases as their sole clinical evidence of HIV infection.
• Known hypersensitivity to immunoglobulin.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (51)

Kaiser Permanente / UCLA Med Ctr

Downey, California, 902422814, United States

Location

Long Beach Memorial (Pediatric)

Long Beach, California, 90801, United States

Location

Children's Hosp of Los Angeles/UCLA Med Ctr

Los Angeles, California, 900276016, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Cedars Sinai / UCLA Med Ctr

Los Angeles, California, 900481804, United States

Location

Martin Luther King Jr Gen Hosp / UCLA Med Ctr

Los Angeles, California, 900593019, United States

Location

UCLA Med Ctr / Pediatric

Los Angeles, California, 900951752, United States

Location

Stanford Univ School of Medicine

Menlo Park, California, 94025, United States

Location

Children's Hosp of Oakland

Oakland, California, 946091809, United States

Location

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

Northern California Pediatric AIDS Treatment Ctr / UCSF

San Francisco, California, 94143, United States

Location

Olive View Med Ctr

Sylmar, California, 91342, United States

Location

Univ of Connecticut Health Ctr / Pediatrics

Farmington, Connecticut, 06032, United States

Location

Emory Univ School of Medicine

Atlanta, Georgia, 30303, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Univ of Illinois College of Medicine

Chicago, Illinois, 60612, United States

Location

Chicago Children's Memorial Hosp

Chicago, Illinois, 606143394, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, 21201, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

Boston Med Ctr

Boston, Massachusetts, 02118, United States

Location

Univ of Massachusetts Med Ctr

Worcester, Massachusetts, 01655, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

Newark, New Jersey, 071072198, United States

Location

SUNY / Health Sciences Ctr at Brooklyn / Pediatrics

Brooklyn, New York, 11203, United States

Location

City Hosp Ctr at Elmhurst / Mount Sinai Hosp

Elmhurst, New York, 11373, United States

Location

Schneider Children's Hosp / Long Island Jewish Med Ctr

New Hyde Park, New York, 11042, United States

Location

Beth Israel Med Ctr / Pediatrics

New York, New York, 10003, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10025, United States

Location

Metropolitan Hosp Ctr

New York, New York, 10029, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Columbia Univ Babies' Hosp

New York, New York, 10032, United States

Location

Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Lincoln Hosp Ctr / Pediatrics

The Bronx, New York, 10451, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Westchester Hosp / New York Med College / Pediatrics

Valhalla, New York, 10595, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Holmes Hosp / Univ of Cincinnati Med Ctr

Cincinnati, Ohio, 452670405, United States

Location

Univ Hosp of Cleveland / Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Columbus Children's Hosp

Columbus, Ohio, 432052696, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Saint Christopher's Hosp for Children

Philadelphia, Pennsylvania, 191341095, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Hermann Hosp / Univ Texas Health Science Ctr

Houston, Texas, 77030, United States

Location

Texas Children's Hosp / Baylor Univ

Houston, Texas, 77030, United States

Location

Children's Hosp of Seattle

Seattle, Washington, 98105, United States

Location

Ramon Ruiz Arnau Univ Hosp / Pediatrics

Bayamón, 00619, Puerto Rico

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

UPR Children's Hosp / San Juan City Hosp

San Juan, 00936, Puerto Rico

Location

Related Publications (5)

• Connor E, McSherry G. Treatment of HIV infection in infancy. Clin Perinatol. 1994 Mar;21(1):163-77.

  PMID: 7912175 BACKGROUND

• Mofenson LM, Moye J Jr. Intravenous immune globulin for the prevention of infections in children with symptomatic human immunodeficiency virus infection. Pediatr Res. 1993 Jan;33(1 Suppl):S80-7; discussion S87-9. doi: 10.1203/00006450-199305001-00464.

  PMID: 8433880 BACKGROUND

• Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

  PMID: 21037891 BACKGROUND

• Spector SA, Gelber RD, McGrath N, Connor EM, Wara DW, Balsley JF. Results of a double-blind placebo-controlled trial to evaluate intravenous gamma globulin in children with symptomatic HIV infection receiving zidovudine (ACTG 051). The Pediatric AIDS Clinical Trials Group and the NICHD Pediatric HIV Centers. Int Conf AIDS. 1993 Jun 6-11;9(1):48 (abstract no WS-B05-6)

  BACKGROUND

• Spector SA, Gelber RD, McGrath N, Wara D, Barzilai A, Abrams E, Bryson YJ, Dankner WM, Livingston RA, Connor EM. A controlled trial of intravenous immune globulin for the prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. Pediatric AIDS Clinical Trials Group. N Engl J Med. 1994 Nov 3;331(18):1181-7. doi: 10.1056/NEJM199411033311802.

  PMID: 7935655 BACKGROUND

MeSH Terms

Conditions

HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome; Bacterial Infections

Interventions

Immunoglobulins; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Spector, SA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: April 1, 1993
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (48); PR (3)