Pharmacokinetics and Bioavailability of Dideoxycytidine in Patients With Human Immunodeficiency Virus Infection
Zalcitabine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Laboratory tests have shown that ddC is effective in stopping the growth of the HIV in test tubes. The study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. This should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known. Patients are hospitalized and receive ddC twice, once by mouth and once by IV injection. Each patient receives the drug at one of six increasing doses, and no patient is studied at more than one dose level. Following each dose, toxicity is measured before the next higher dose is given. Several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body.
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 Prior Medication: Allowed: Oral nonabsorbable antifungal agents. Exclusion Criteria Active drug or alcohol abuse. Co-existing Condition: Patients with fever > 102 degrees F at study entry will be excluded. Patients with fever > 102 degrees F at study entry will be excluded. Prior Medication: Excluded: Chronic systemic medications. Any other experimental drug within 2 weeks of study entry. Drugs with known nephrotoxic or hepatotoxic effects within 2 weeks of study entry. Drugs known to cause neutropenia within 2 weeks of study entry. Rifampin or rifampin derivatives, phenytoin, or barbiturates within 2 weeks of study entry. Any other medication except oral nonabsorbable antifungal agents within 72 hours of study entry. All medications, including aspirin, must be approved by investigator. All medications, including aspirin, must be approved by investigator. Patients must demonstrate the following clinical and laboratory findings: AIDS, AIDS related complex (ARC), or persistent generalized lymphadenopathy as defined by the CDC classification. No ascites. Off all medications except oral antifungal, nonabsorbable agents for 72 hours prior to study entry.
Centres d'étude
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