Terminé

Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1

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Ce qui est testé

Collecte de données

Qui peut participer

Infections transmises par le sang+21

+ Maladies génito-urinaires

+ Maladies Génitales

À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 1
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

HIV-infected patients may develop a condition known as HIV-Associated Motor / Cognitive Complex (also known as AIDS dementia complex) that causes damage to the nervous system, particularly the brain and spinal cord. Evidence exists that nimodipine protects nerve cells in culture from injury by HIV. Although nimodipine has been used in patients with other neurological problems, its safety and effectiveness in halting the progression of HIV-Associated Motor / Cognitive Complex is not yet known. Forty patients currently taking zidovudine (AZT) or any other approved antiretroviral agent will be randomized to one of three treatment arms: high-dose nimodipine, low-dose nimodipine, or placebo. Additionally, six patients who are intolerant to standard antiretroviral therapy will be randomized to receive high- or low-dose nimodipine. Nimodipine is administered by mouth concurrently with patients' prestudy dose of antiretroviral agent. Treatment is given for 16 weeks, and patients are followed every 4 weeks. As an option, all patients may receive an additional 16 weeks of low-dose nimodipine.

Titre officielRandomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
NCT00000738
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

36 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.

À partir de 18 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 AcquiseComplexe associé au SIDATroubles MentauxMaladies du cerveauMaladies du système nerveux centralMaladies TransmissiblesDémenceSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsMaladies du système nerveuxInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesComplexe de démence du SIDAInfections à VIHInfections à LentivirusTroubles Neurocognitifs

Critères

Inclusion Criteria Concurrent Medication: Allowed: * Alternative or additional antiretroviral agents if on a stable dose for 8 weeks prior to study entry. * Isoniazid. * Anticonvulsants. * Benzodiazepines and antidepressants (provided dose is stable prior to study entry). * Symptomatic therapies (e.g., analgesics, antihistamines, antiemetics, and antidiarrheal agents). * Maintenance therapy with clarithromycin, azithromycin, amikacin, ethambutol, clofazimine, ciprofloxacin, and rifampin for disseminated Mycobacterium avium infection. * Maintenance therapy for opportunistic infections (e.g., PCP, MAI, CMV). Patients must have: * Documented HIV infection. * HIV-Associated Motor / Cognitive Complex. * Acceptable neurological and neuropsychological impairment scores. * Estimated premorbid IQ of 70 or greater, consistent with completion of the sixth grade or ability to read at the sixth grade level. Current ability to read and comprehend a newspaper or history of such ability will satisfy this criterion for patients whose formal education stopped before the sixth grade. For patients who are illiterate, ability to make change from a dollar for a combined purchase of two items or the history of such ability will satisfy this criterion. In the absence of a functional definition, an age-correlated scaled score of \> 5 on the Vocabulary Subtest of the WAIS-R or WISC-R may be used to establish IQ. * Ability to provide written informed consent. Prior Medication: Required: * AZT for at least 12 weeks prior to study entry or any other approved antiretroviral agent (i.e., ddI or ddC) for at least 8 weeks prior to study entry, except in antiretroviral-intolerant patients who must be off antiretrovirals for at least 4 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Active symptomatic AIDS-defining opportunistic infection (maintenance therapy for opportunistic infections, e.g., Pneumocystis carinii pneumonia, Mycobacterium avium infection, and cytomegalovirus, is permitted). * Neoplasms other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or that do not require systemic chemotherapy. * Confounding neurological disorders, including the following: * a) neurologic disease unrelated to HIV infection (such as multiple sclerosis, documented stroke, degenerative disease); b) chronic seizure disorders or head injuries if the condition results in functional impairment or is likely to interfere with evaluations; c) central nervous system (CNS) infections or neoplasms (such as toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, tuberculous CNS infections, or untreated neurosyphilis). * Severe premorbid psychiatric illness including bipolar illness, schizophrenia, and depression requiring electroconvulsive therapy. * Major depression likely to interfere with evaluation or protocol compliance. Concurrent Medication: Excluded: * Major psychotropic medication, including MAO inhibitors, phenothiazines, butyrophenones, barbiturates, or amphetamines (unless a stable dose is maintained for 30 days prior to study entry). * Any ongoing maintenance therapy for confounding neurological disorders. Patients with the following prior conditions are excluded: Confounding neurological disorders defined in the "Exclusion Co-existing Conditions" field. Prior Medication: Excluded: * Investigative drugs within 30 days prior to study entry. * Confounding calcium channel antagonists (such as nifedipine, verapamil, diltiazem, and related drugs) within 4 weeks prior to study entry. 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 12 sites

Suspendu

UCLA CARE Center CRS

Los Angeles, United StatesOuvrir UCLA CARE Center CRS dans Google Maps
Suspendu

Northwestern University CRS

Chicago, United States
Suspendu

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, United States
Suspendu

Massachusetts General Hospital ACTG CRS

Boston, United States
Terminé12 Centres d'Étude