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A Study of Zidovudine in HIV-Infected Patients With Kidney Problems

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Ce qui est testé

Zidovudine

Médicament
Qui peut participer

HIV Infections

+ Kidney Disease
À partir de 18 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 1
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 2 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To determine how zidovudine (AZT) for the treatment of HIV infection is metabolized and excreted or eliminated in patients with infected or diseased kidneys. To determine the influence of hemodialysis and establish dose guidelines. AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV infection. Persons with HIV infection may have additional health problems, one of which is a diseased kidney due to infection of the kidney, or side effects of therapy. The benefits and risks of AZT in patients with diseased kidneys are unknown. It is hoped that this study will allow further understanding of the metabolism and excretion of AZT in patients with kidney disease. AZT pharmacokinetics will be studied in patients with mild, moderate, and severe renal disorders AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV infection. Persons with HIV infection may have additional health problems, one of which is a diseased kidney due to infection of the kidney, or side effects of therapy. The benefits and risks of AZT in patients with diseased kidneys are unknown. It is hoped that this study will allow further understanding of the metabolism and excretion of AZT in patients with kidney disease. AZT pharmacokinetics will be studied in patients with mild, moderate, and severe renal disorders. Patients receive AZT by mouth on the first day. After taking the AZT, blood samples are taken from a catheter and several urine samples are collected over a 24-hour period. During this time, patients remain in the hospital for the 24 hours or may choose to go home 12 hours after taking the AZT dose and return for the last blood sample the next morning. Following study day 1, patients receive AZT every 4 hours, including in the middle of the night, and keep a diary of the times they take AZT, as well as of the use of other medications, tobacco, or alcohol. A return appointment is made for 8-15 days later. On that day, patients again receive AZT by mouth, and blood tests and urine samples are again taken. Patients who are receiving hemodialysis participate in 1 additional day of pharmacokinetic studies to be arranged during one hemodialysis session. Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD) are studied separately and do not participate in the procedures for the other groups. AZT is given as a single oral dose at the beginning of the first morning exchange followed by a pharmacokinetic study. Chronic AZT dosing is initiated following the first exchange. After a minimum of 7 days of AZT therapy and a maximum of 14 days the last dose of AZT is administered and a repeat pharmacokinetic study is done. All patients are seen again 1-2 weeks after completing the last pharmacokinetic study.

Titre officielEvaluation of Zidovudine Pharmacokinetics in Patients With Human Immunodeficiency Virus and Varying Degrees of Renal Insufficiency 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 2 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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
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.

Comment la nature du traitement est tenue confidentielle
Dans une étude en ouvert, tous les participants ainsi que les chercheurs savent quel traitement est administré. Ce type de protocole est utilisé lorsqu'il n'est pas nécessaire ou pas possible de masquer les traitements.

Autres méthodes de masquage
Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

Double aveugle
: ni les participants ni les chercheurs ne savent quel traitement est administré.

Triple aveugle
: Les participants, les chercheurs et les personnes qui analysent les résultats ne savent pas quel traitement est administré.

Quadruple aveugle
: Les participants, les chercheurs, les personnes qui analysent les résultats et les professionnels de santé en charge du suivi ne savent pas non plus quel traitement est administré.

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 sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 18 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
HIV Infections
Kidney Disease
Critères

Inclusion Criteria Concurrent Medication: Allowed: * Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy. * Aerosolized pentamidine. Discouraged: - Sucralfate or antacids. However if these medications are essential for the patient's management, they should not be given within 8 hours before or 2 hours after the scheduled pharmacokinetic study. - Concurrent Treatment: Allowed: * Blood transfusions. Patients must have HIV infection with renal insufficiency and acceptable hepatic and hematologic function. They must have been on dialysis treatment for at least 3 months. Prior Medication: Allowed: * Cytotoxic chemotherapy for local mucocutaneous lesions. * Aerosolized pentamidine. Exclusion Criteria Concurrent Medication: Excluded: * Ongoing therapy for opportunistic infections, including systemic maintenance therapy which cannot be discontinued for the duration of the study, such as amphotericin B or ganciclovir. * H-2 blockers. * Zidovudine (AZT). * Other antiretroviral agents or other experimental therapy. Discouraged: - Sucralfate or antacids. However, if these medications are essential for the patient's management, they should not be given within 8 hours before or 2 hours after the scheduled pharmacokinetic study. - Patients will be excluded from the study for the following reasons: * Presence of active opportunistic infections. * Severe malabsorption syndrome (persistent diarrhea greater than 4 weeks duration with = or \> 4 loose stools per day accompanied by = or \> 10 percent unintentional weight loss. * Acute illness, febrile or unstable, 48 hours prior to the first pharmacokinetic study. * Known sensitivity to zidovudine or thymidine-type agents. * Diabetes mellitus requiring treatment. Prior Medication: Excluded: - Treatment for diabetes mellitus. Excluded within 72 hours of study entry: * H-2 blockers. * Zidovudine (AZT). Excluded within 2 weeks of study entry: * Other antiretroviral agents or other experimental therapy. * Rifampin or rifampin derivatives. * Probenecid. * Dilantin. * Methadone. * Oral contraceptives. * Barbiturates. * Significant hepatotoxic agents or valproic acid. * TMP / SMX. * Dapsone. * Fansidar. Excluded within 30 days of study entry: - Cytotoxic chemotherapy. Prior Treatment: Excluded within 30 days of study entry: * Radiation therapy for local mucocutaneous lesions. Risk Behavior: Active drug or alcohol use which might interfere with the study objectives. * Note: Alcohol consumption is prohibited 48 hours prior to the first pharmacokinetic study and during the study. Tobacco smoking is not excluded although tobacco use will be quantified. Patients may not have any of the following diseases or symptoms: * Presence of active opportunistic infections. * Severe malabsorption syndrome (persistent diarrhea greater than 4 weeks duration with = or \> 4 loose stools per day accompanied by = or \> 10 percent unintentional weight loss. * Acute illness, febrile or unstable, 48 hours prior to the first pharmacokinetic study. * Diabetes mellitus.



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
Suspendu
Univ of North CarolinaChapel Hill, United StatesVoir le site
Suspendu
Univ of WashingtonSeattle, United States

Suspendu2 Centres d'Étude