Terminé

A Safety, Tolerance, and Immunological Study of a Combination of Recombinant Interleukin 2 and Zidovudine in Patients With AIDS or AIDS Related Complex

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Ce qui est testé

Zidovudine

+ Aldesleukin

Médicament
Qui peut participer

Infections transmises par le sang+14

+ Maladies génito-urinaires

+ Maladies Génitales

De 18 à 50 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 : 4 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

AZT is an antiviral drug, which has been shown to be beneficial in some patients with AIDS. IL-2 is a substance found naturally in the body that boosts the body's immune response to invading organisms and tumor cells. These two drugs, when administered together, may have a mutually helpful effect in treating AIDS patients, but before this effect can be studied, it is important to understand the proper dose and any side effects that may occur when these drugs are used together. The study will show how much AZT and IL-2 patients can safely take at the same time and how the two drugs will interact with each other. AMENDED: Note that the dose of AZT changed 900214 to reflect new dose recommendations. Original design: Six weeks before beginning treatment with IL-2, patients are given AZT daily. There are three patient groups, one for each dose level of IL-2. On the first day of treatment with the two drugs together, patients are admitted to Presbyterian University Hospital, where AZT is administered orally every 4 hours and IL-2 is given once a day as a single injection under the skin. Clinical and laboratory safety data from the first two patients enrolled in each treatment group will be analyzed prior to enrolling additional patients in each group. All patients are expected to stay in the hospital for at least 5 days, and some may stay longer if serious side effects develop. AZT treatment will continue after the patient leaves the hospital for an additional 10 weeks. Follow-up visits are scheduled for days 6, 8, and 15 for safety, immunologic, and virologic evaluations. Thereafter, patients are followed by telephone interview every other week and come into the clinic if a change in health is reported. At weeks 10 and 20, patients are also evaluated in a follow-up clinic visit.

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 4 novembre 2021
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

18 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 50 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 GénitalesMaladies TransmissiblesSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à LentivirusSyndrome d'Immunodéficience AcquiseComplexe associé au SIDAInfections à VIH

Critères

Inclusion Criteria Concurrent Medication: Allowed: Acetaminophen under the supervision of a study physician. Prior Medication: Required for at least 6 weeks prior to study entry: Zidovudine at a dose of at least 300 mg/day. Allowed: Aerosolized pentamidine prior to combination therapy. Patients must demonstrate the following clinical and laboratory findings: Currently receiving zidovudine (AZT) at a dose of at least 300 mg/day and have received the drug for at least 6 weeks. Have a life expectancy of = or > 4 months. Available for the duration of the study and for follow-up visits. Exclusion Criteria Co-existing Condition: Patients with the following conditions will be excluded: Evidence of active life-threatening opportunistic infection with bacterial, viral, fungal, or protozoan pathogens during the 6-week period prior to and during the 5-day period of combination therapy. A fever > 101 degrees F within the past 10 days. Significant central nervous system disease, including acquired immunodeficiency syndrome (AIDS), dementia, psychiatric disabilities, or seizure disorders. Significant cardiac (New York Heart Association stage III or IV) and/or pulmonary disease (forced expiratory volume < 75 percent). Kaposi's sarcoma or other AIDS related malignancy. Evidence of malabsorption as indicated by 10 percent weight loss within the last 3 months. Concurrent Medication: Excluded: Cardiac medications. Glucocorticosteroids. Probenecid. Acetylsalicylic acid. Trimethoprim / sulfamethoxazole. Acyclovir. Allopurinol. Drugs causing anemia, neutropenia, or nephrotoxicity. Aerosolized pentamidine during combination therapy. Nonsteroidal anti-inflammatory drugs by patients with thrombocytopenia (<75000 platelets/mm3). Acetaminophen except under supervision of a study physician. Patients with the following conditions will be excluded: Evidence of active life-threatening opportunistic infection with bacterial, viral, fungal, or protozoan pathogens during the 6-week period prior to and during the 5-day period of combination therapy. A fever > 101 degrees F within the past 10 days. Significant central nervous system disease, including acquired immunodeficiency syndrome (AIDS), dementia, psychiatric disabilities, or seizure disorders. Significant cardiac (New York Heart Association stage III or IV) and/or pulmonary disease (forced expiratory volume < 75 percent). Kaposi's sarcoma or other AIDS related malignancy. Evidence of malabsorption as indicated by 10 percent weight loss within the last 3 months. Prior Medication: Excluded within 4 weeks of study entry: Any antiretroviral drug, except zidovudine (AZT). Excluded within 12 weeks of study entry: Immunotherapy, including interleukins, interferons, tumor necrosis factor. Other cytokines. Biologic response modifiers. Monoclonal antibodies. BCG vaccines. Active drug or alcohol 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 1 site

Univ of Pittsburgh Med School

Pittsburgh, United StatesOuvrir Univ of Pittsburgh Med School dans Google Maps
Terminé1 Centres d'Étude