Terminé

A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Zidovudine

Médicament
Qui peut participer

AIDS Dementia Complex

+ HIV Infections
À partir de 12 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 3
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

To test whether zidovudine (AZT) is useful as a treatment for the neurologic syndrome called AIDS dementia complex. To determine how long AZT takes to reach cerebral spinal fluid (CSF), how long, and at what concentration it is found there. HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex. HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex. The study is done in 2 stages. In Stage 1, patients are randomized to receive placebo or 1 of 2 doses of AZT. Stage 1 lasts for 4 months. In Stage 2, patients who were initially treated with placebo are randomized again and all patients receive AZT. Stage 2 lasts an additional 12 months, during which time there are periodic medical and neurologic evaluations. Before beginning treatment, all patients have a lumbar puncture and a computerized tomographic (CT) scan of the brain. The lumbar puncture is repeated twice during and once at the end of Stage 1; the CT scan is also repeated at the end of Stage 1. Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week for the first 4 weeks and every other week thereafter for the first 4 months of receiving the drug. After 4 months, patients are seen by their physicians at 4 to 12 week intervals.

Titre officielA Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection 
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
315 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 double aveugle, ni les participants ni les chercheurs ne savent quel traitement est administré. C'est la méthode la plus rigoureuse pour éviter tout biais lié aux attentes et garantir des résultats fiables.

Autres méthodes de masquage
En ouvert
: tout le monde connaît le traitement administré.

Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

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.
À partir de 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
AIDS Dementia Complex
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Allowed: * Aspirin, in modest doses. * Ibuprofen, in modest doses. * Maintenance antibiotic therapy posttherapy for an AIDS-defining opportunistic infection. Concurrent Treatment: Allowed: * Blood transfusion if cardiovascular status is compromised. Exclusion Criteria * Active substance abuse. Co-existing Condition: Patients with the following conditions will be excluded: * Concurrent or previous central nervous system infections or neoplasms. * Active AIDS-defining opportunistic infection. * Severe premorbid psychiatric illness. * Confounding neurological disease. * Concurrent neoplasms. Concurrent Medication: Excluded: * Maintenance methadone or naltrexone. * Acetaminophen. * Mood- or central nervous system-altering drugs. * Zidovudine for Pneumocystis carinii pneumonia (PCP). * Acyclovir. * Rifampin or derivatives. * Drugs with antiretroviral activity. * Experimental agents. The following patients will be excluded from the study: * Patients requiring ongoing therapy for an AIDS-defining opportunistic infection. * Patients with a history of Mycobacterium avium intracellulare infection. * Patients with a history of Pneumocystis carinii pneumonia infection. * Patients with a daily temperature of 38 degrees C or more for 1 month. Prior Medication: Excluded: * Zidovudine (AZT). * Excluded within 14 days of study entry: * Systemic anti-infectives. * Excluded within 30 days of study entry: * Immunomodulators and biologic response modifiers. * Any investigational agent. * Cytotoxic chemotherapy for Kaposi's sarcoma. Prior Treatment: Excluded: * Radiation therapy. Patients must demonstrate the following clinical and laboratory findings: * No currently active AIDS-defining opportunistic infections. * One negative blood culture for Mycobacterium avium intracellulare within 4-6 weeks prior to study entry. * Constitutionally well without persistent fever. * Less than 25 Kaposi's sarcoma lesions and less than 10 new lesions during the 30 days prior to study entry. Patients may have stable or indolently progressive mucocutaneous Kaposi's sarcoma. * Characteristic clinical symptoms and signs of AIDS dementia complex. * Abnormalities on 2 or more of 7 neuropsychological motor tests in the Neurological Screening Battery. * Estimated premorbid IQ equal to or greater than 70 (+ or - 5), which is consistent with completion of sixth grade.



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 21 sites
Suspendu
UCLA CARE CtrLos Angeles, United StatesVoir le site
Suspendu
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspendu
Stanford Univ School of MedicineStanford, United States
Suspendu
Univ of Miami School of MedicineMiami, United States

Terminé21 Centres d'Étude