Terminé

An Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection

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Ce qui est testé

Collecte de données

Qui peut participer

Infections transmises par le sang+14

+ Maladies génito-urinaires

+ Maladies Génitales

De 18 à 60 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

Although zidovudine (AZT) prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a few patients for short periods of time and has been found to be well tolerated. Patients receive AL-721 twice daily. The first dose is taken on an empty stomach 1 hour before a fat-free breakfast, with specific instructions given on foods that are allowed; the second dose is taken at least 3 hours after the evening meal. No snacks are permitted after the evening meal or after the evening dose of study medication. The study is scheduled to last for 16 weeks of treatment and 4 weeks of follow-up. Throughout the study, frequent blood samples will be taken from an arm vein. The blood samples are studied to evaluate any changes in the patient's immune system, any toxic effects that might be detected in the blood, and any changes in the presence of the HIV in the blood.

Titre officielAn Open Label, Multiple Dose Ranging Trial of AL721 in Patients With Persistent Generalized Lymphadenopathy and Symptomatic HIV Infection
NCT00001012
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

50 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 18 à 60 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 SIDAMaladies TransmissiblesSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à VIHInfections à Lentivirus

Critères

Inclusion Criteria * Persistent generalized lymphadenopathy (PGL) (CDC-Group III), defined as palpable lymphadenopathy (nodes of 1 cm or greater) at two or more noncontiguous extrainguinal sites persisting for \> 3 months in the absence of an illness other than HIV infection to account for the findings. * AIDS related complex (ARC), defined as the presence of at least one of the following findings within 12 months prior to entry and the absence of a concurrent illness or condition other than HIV infection to explain the findings: * Any findings which define CDC-Group IV A. * History of any one of the findings that define CDC-Group IV C2. * Patients with any of the ARC symptoms can also have PGL and be enrolled in the protocol as ARC patients. * A positive antibody to HIV by any federally licensed ELISA test kit within 30 days of entry. Concurrent Medication: Allowed: * Topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study. Exclusion Criteria * Exclude hemophiliacs. * Active substance abuse. * Alcohol consumption should be kept to a minimum. Co-existing Condition: Patients with the following will be excluded: * Hemophilia. * History or presence of an AIDS-defining opportunistic infection or malignancy. * AIDS related complex (ARC) patients with prior (within the last 12 months) or current history of diarrhea defined as = or \> 3 liquid stools per day persisting for longer than 1 month. * Significant malabsorption: * Greater than 10 percent weight loss within past 3 months with serum carotene \< 75 IU/ml or vitamin A \< 75 IU/ml. * Significant cardiac, liver, renal, or neurologic disorder. * Active ARC-defining secondary infection (oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia or Nocardiosis) undergoing therapy or prophylaxis within 7 days of study entry. * Active tuberculosis under treatment. * Concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Concurrent Medication: Excluded: * Any medication that will interfere with the assessment of AL-721, including nutritional supplements, vitamins, laxatives, and over-the-counter products containing lecithin. * Chemoprophylaxis for Pneumocystis carinii (PCP), candida, herpes simplex, herpes zoster infections, or bacterial infections. * Intravenous topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study. * Systemic chemotherapy. Prior Medication: Excluded within 30 days of study entry: * Any investigational drug. * Biologic response modifiers. * Corticosteroids. * Chemotherapeutic agents. * Excluded within 90 days of study entry: * Any antiretroviral agent or AL-721.

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 9 sites

Suspendu

Los Angeles County - USC Med Ctr

Los Angeles, United StatesOuvrir Los Angeles County - USC Med Ctr dans Google Maps
Suspendu

Charity Hosp / Tulane Univ Med School

New Orleans, United States
Suspendu

Louisiana State Univ Med Ctr / Tulane Med School

New Orleans, United States
Suspendu

Tulane Univ School of Medicine

New Orleans, United States
Terminé9 Centres d'Étude