Search / Trial NCT00000720

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 26, 2024

Completed

Keywords

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

Description

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 freque...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • 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.
  • Children must have one or more of the indicator diseases of AIDS; however, there must be an absence of acute opportunistic infection and an absence of bacterial infection requiring treatment at the time of entry into the study.
  • Children with lymphoid interstitial proliferation (LIP) are excluded from enrollment unless they have had additional AIDS-defining opportunistic infections, meet ARC criteria, have had two or more serious bacterial infections in the 12 months prior to study entry, have evidence of HIV encephalopathy, or are currently on supplemental oxygen and steroids with a pre-treatment PaO2 < 70 mm Hg.
  • Children with concurrent LIP and ARC are eligible for inclusion. Thrombocytopenia is an exclusion except if it is HIV-associated.
  • Children randomized prior to their 13th birthday are eligible.
  • All lab values must be within 4 weeks of study entry.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT).
  • Exclusion Criteria
  • 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.
  • Active HIV thrombocytopenia requiring IVIG therapy.
  • Inability to establish or maintain intravenous access.
  • Lack of parental or guardian authorization for intravenous access.
  • Prior Medication:
  • Excluded within 4 weeks of study entry:
  • Any other experimental therapy.
  • Other antiretroviral agents.
  • Drugs which cause prolonged neutropenia or significant nephrotoxicity.
  • Immunoglobulins.
  • Immunomodulating agents.
  • Active alcohol or drug abuse.

Attachments

readout_NCT00000720_2024-05-26.pdf

4.5 MB

NCT00000720_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

Downey, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Oakland, California, United States

San Diego, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Newark, New Jersey, United States

Bronx, New York, United States

Brooklyn, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Houston, Texas, United States

Seattle, Washington, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

Sylmar, California, United States

Elmhurst, New York, United States

Los Angeles, California, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Boston, Massachusetts, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Atlanta, Georgia, United States

Los Angeles, California, United States

Menlo Park, California, United States

San Francisco, California, United States

Farmington, Connecticut, United States

Chicago, Illinois, United States

Bronx, New York, United States

New Hyde Park, New York, United States

Valhalla, New York, United States

San Juan, , Puerto Rico

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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