Terminé

Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma

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Ce qui est testé

Interferon alfa-2a

+ Zidovudine

Médicament
Qui peut participer

Infections transmises par le sang+21

+ Maladies génito-urinaires

+ Maladies Génitales

À partir de 12 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Voir le détail du protocole

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 en tant que partenaire

In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens. Following evaluation studies, patients who participate in the study receive IFN-A2a and AZT. IFN-A2a is administered as a single subcutaneous injection once a day. AZT is given in a single capsule every 4 hours through the day for a total of six capsules. The first phase of treatment continues for 8 weeks followed by a 1-week rest period, during which time AZT only is given. Subjects who have had an interruption in interferon during the first 8 weeks of the study for a toxicity may skip the rest period. Patients experiencing a complete response will be placed on maintenance therapy. Patients without progression of their KS can continue on the treatment of AZT and IFN-A2a until a complete response is obtained or until study is terminated, whichever comes first. Patients with complete anti-tumor response can continue on a maintenance phase, in which they receive IFN-A2a as a single injection 3 times a week on nonconsecutive days and a single capsule of AZT q4h 6 x /day until the study is terminated on February 1, 1992. Patients are required to visit the clinic weekly for the first 12 weeks (except during the week 9 rest period), every other week for the next 8 weeks, every month for up to 52 weeks of the study and every 3 months thereafter. Throughout the study, frequent blood samples will be taken to monitor the effectiveness and safety of the treatment.

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 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

60 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 12 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 TransmissiblesInfections par virus ADNInfections à HerpèsviridaeSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsNéoplasmesNéoplasmes par type histologiqueTumeurs VasculairesInfections à RetroviridaeInfections à virus ARNSarcomeMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à LentivirusNéoplasmes, tissu conjonctif et tissu mouSyndrome d'Immunodéficience AcquiseSarcome de KaposiInfections à VIH

Critères

Inclusion Criteria Concurrent Medication: Allowed: Inhalation pentamidine for the prevention of Pneumocystis carinii pneumonia (PCP) at a dose of 300 mg once every 4 weeks. AMENDED: Trimethoprim - sulfamethoxazole or dapsone only if on the maintenance phase of the study. Concurrent Treatment: Allowed: Blood transfusions. Patients must have a positive antibody to HIV by any federally licensed ELISA test. All lab tests must be within 7 days of entry into the study. Exclusion Criteria Concurrent Medication: Excluded: Other antiretroviral agents. Immunomodulators. Corticosteroids. Cytotoxic chemotherapy. Aspirin. H2 blockers. Barbiturates and myelosuppressive drugs should be particularly avoided as they may interfere with the metabolism or enhance the toxicities of either zidovudine or interferon alfa-2a. Other experimental medications. Concurrent Treatment: Excluded: Radiation therapy. Patients with prior experience of Grade 4 toxicity to zidovudine therapy will be excluded from the study. Prior Medication: Excluded: Interferon therapy. Excluded within 30 days of study entry: Immunomodulators. Corticosteroids. Cytotoxic chemotherapeutic agents. Excluded within 14 days of study entry: Zidovudine (AZT). Prior Treatment: Excluded within 30 days of study entry: Blood transfusions. Radiation therapy. Patients may not have any of the following diseases or symptoms: Active opportunistic infection associated with AIDS. Significant neurologic disease associated with AIDS, as manifested by motor abnormalities including impaired rapid eye movement or ataxia, motor weakness in the lower extremities, sensory deficit consistent with a peripheral neuropathy, bladder or bowel incontinence. Internal organ involvement with Kaposi's sarcoma, i.e., nonnodal visceral Kaposi's sarcoma, excluding minimal gastrointestinal disease of less than 5 lesions. Tumor-associated edema. Current neoplasm other than Kaposi's sarcoma. Significant cardiac disease, including a recent history of myocardial infarction or significant current cardiac arrhythmias. 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 9 sites

Univ. of Miami AIDS CRS

Miami, United StatesOuvrir Univ. of Miami AIDS CRS dans Google Maps

Johns Hopkins Adult AIDS CRS

Baltimore, United States

Beth Israel Deaconess - East Campus A0102 CRS

Boston, United States

Washington U CRS

St Louis, United States
Terminé9 Centres d'Étude