Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy
Collecte de données
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
It is hypothesized that the maximum AZT antiretroviral effect, which occurs at 8 weeks of therapy, will be enhanced by 2 weeks of foscarnet treatment, given at the same time by intermittent intravenous infusion. In addition, the further lowering of serum p24 antigen concentration that should occur during combined therapy might continue when oral AZT therapy is continued without foscarnet. There is a 4-week prestudy monitoring period during which AZT alone is administered on an outpatient basis, followed by a 2-week study period during which both intravenous foscarnet and oral AZT are administered in the hospital. During the subsequent 6-month follow-up period, oral AZT is administered and patients receive clinical evaluations. AZT is held for 48 hours on days before hospitalization and for 24 hours at the end of the hospitalization.
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.12 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.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
Critères
Inclusion Criteria Concurrent Medication: Allowed: Medication necessary for the patient's welfare at the discretion of the investigator. Patients must have the following: * Received zidovudine (AZT) 200 mg every 4 hours (q4h) continuously for 8 - 16 weeks without Grade 3 or higher toxicity. * Detectable p24 antigen in serum on at least 2 occasions during the prestudy period. All serum p24 antigen concentrations measured during the prestudy period must be at least twice the concentration cutoff value of the assay. * Capability of giving informed consent. * Per amendment of 890721, patients must enter the study period by September 30, 1989. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: * A history of hypersensitivity reaction to foscarnet or zidovudine (AZT). * History of Grade 3 or 4 toxicity with AZT. * Current Grade 2 or higher AZT toxicity. * Osteomalacia, neoplasm metastatic to bone, or other known bone disease. * Active opportunistic infection requiring myelosuppressive or nephrotoxic therapy. Concurrent Medication: Excluded: * Antimetabolites. * Immunomodulators. * Nephrotoxins. * Antiviral therapy. * Myelosuppressive or nephrotoxic therapy. * Acetaminophen. Patients with the following will be excluded: * A history of hypersensitivity reaction to foscarnet or zidovudine (AZT). * History of Grade 3 or 4 toxicity with AZT. * Current Grade 2 or higher AZT toxicity. * Osteomalacia, neoplasm metastatic to bone, or other known bone disease. * Active opportunistic infection requiring myelosuppressive or nephrotoxic therapy.
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 2 sites
University of Minnesota, ACTU
Minneapolis, United StatesOuvrir University of Minnesota, ACTU dans Google MapsUnc Aids Crs
Chapel Hill, United States