Terminé

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

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Ce qui est testé

Collecte de données

Qui peut participer

Infections transmises par le sang+17

+ Maladies génito-urinaires

+ Maladies Génitales

De 3 mois à 12 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 3
Interventionnel
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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. The study includes 250 children, 3 months to 12 years of age. All participants receive oral AZT. IVIG or intravenous placebo is administered every 28 days. Patients are followed for the development of serious bacterial infection, as well as for a number of factors relating to safety, tolerance, progression of disease, and survival. This is an outpatient study conducted over a minimum 100-week period. The children are evaluated every 2 weeks for the first 8 weeks, and monthly thereafter.

Titre officielA Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine
NCT00000720
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

250 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 3 mois à 12 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Infections transmises par le sangMaladies génito-urinairesMaladies GénitalesSyndrome d'Immunodéficience AcquiseInfections bactériennesInfections bactériennes et mycosesMaladies TransmissiblesSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsInfections opportunistesInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à VIHInfections à LentivirusInfections opportunistes liées au SIDA

Critères

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.

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 51 sites

Suspendu

Kaiser Permanente / UCLA Med Ctr

Downey, United StatesOuvrir Kaiser Permanente / UCLA Med Ctr dans Google Maps
Suspendu

Long Beach Memorial (Pediatric)

Long Beach, United States
Suspendu

Children's Hosp of Los Angeles/UCLA Med Ctr

Los Angeles, United States
Suspendu

Los Angeles County - USC Med Ctr

Los Angeles, United States
Terminé51 Centres d'Étude