Terminé

A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

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Ce qui est testé

Zidovudine

Médicament
Qui peut participer

HIV Infections

De 3 mois à 12 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 3 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children. Patients are hospitalized for 8 weeks to receive AZT through the intravenous (IV) route at 1 of 2 doses. Patients are then discharged from hospital and take AZT by mouth for 4 more weeks.

Titre officielA Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC) 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 3 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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
12 participants à inclureNombre 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.

Comment la nature du traitement est tenue confidentielle
Dans une étude en ouvert, tous les participants ainsi que les chercheurs savent quel traitement est administré. Ce type de protocole est utilisé lorsqu'il n'est pas nécessaire ou pas possible de masquer les traitements.

Autres méthodes de masquage
Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

Double aveugle
: ni les participants ni les chercheurs ne savent quel traitement est administré.

Triple aveugle
: Les participants, les chercheurs et les personnes qui analysent les résultats ne savent pas quel traitement est administré.

Quadruple aveugle
: Les participants, les chercheurs, les personnes qui analysent les résultats et les professionnels de santé en charge du suivi ne savent pas non plus quel traitement est administré.

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 sexeLe sexe biologique des participants éligibles à s'inscrire.
De 3 mois à 12 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
HIV Infections
Critères

Inclusion Criteria Concurrent Treatment: Allowed: * Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements). Exclusion Criteria Co-existing Condition: Children with the following conditions are excluded: * Asymptomatic with T-lymphocyte deficiency. * Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS. * Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study. * Hemoglobinopathy including sickle cell anemia. * Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth. Children with the following conditions are excluded: * Asymptomatic with T-lymphocyte deficiency. * Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS. * Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study. * Hemoglobinopathy including sickle cell anemia. * Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth. Prior Medication: Excluded: * Suramin. * Ribavirin. * HPA 23. * Phosphonoformate. * Ansamycin. * Interleukin 2. * Interferon. * Excluded within 30 days of study entry: * All cytolytic chemotherapeutic agents, immunomodulating agents including steroids and immunoglobulin preparations. * Antivirals (acyclovir, ganciclovir). Prior Treatment: Excluded within 4 weeks of study entry: * Lymphocyte transfusions for immune reconstitution. * Excluded within 3 months of study entry: * Bone marrow transplant. Child who is seropositive for HIV antibody or has HIV viremia and presents with one or more of following clinical criteria and at least one of the laboratory criteria may be considered an ARC patient for purpose of study: * Clinical criteria: * Persistent oral candidiasis despite appropriate therapy. * Wasting syndrome characterized by failure to thrive and malnutrition. * Recurrent or chronic unexplained diarrhea. * Lymphadenopathy (more than 1 cm) at 2 or more noncontiguous sites. * Hepatomegaly with or without splenomegaly. * Encephalopathy with loss of developmental milestones and cortical atrophy present on computed tomography (CT) examination. * Recurrent bacterial infections (bacteremia, pneumonia, septic arthritis, meningitis). * Cutaneous anergy as defined by lack of delayed cutaneous hypersensitivity to selected antigens. * Laboratory criteria: * Hypergammaglobulinemia (IgG or IgA) defined as immunoglobulin values exceeding the maximum age-adjusted level. * Decreased number of total T-lymphocytes (2 SD from mean). * Absolute depression in T-helper cells to less than 500/mm3. * Depressed (equal to or more than 2 SD from normal mean) in vitro mitogen response to at least one antigen. * One positive HIV culture within 3 months of study entry into the study or blood obtained and culture pending. * Life expectancy greater than 6 months. * Ambulatory and free of opportunistic infection at time of entry. * Reliably diagnosed disease at least moderately indicative of underlying cellular immunodeficiency and no known cause of underlying cellular immunodeficiency or other reduced resistance reported to be associated with that disease. * Disease accepted as sufficiently indicative of underlying cellular immunodeficiency by CDC. In absence of these opportunistic diseases, a histologically confirmed diagnosis of chronic lymphoid interstitial pneumonitis will be considered indicative of AIDS unless test(s) for HIV are negative.



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 2 sites
Suspendu
Univ of Miami School of MedicineMiami, United StatesVoir le site
Suspendu
Duke Univ Med CtrDurham, United States

Terminé2 Centres d'Étude