Terminé

A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Ganciclovir

Médicament
Qui peut participer

Cytomegalovirus Retinitis

+ HIV Infections
De 13 à 60 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 : 3 novembre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral ganciclovir during a 28-day dosing period. Other purposes of the study are to determine in a population of HIV seropositive persons with cytomegalovirus (CMV) viremia, the safety, tolerance, and patient acceptability of oral ganciclovir given for 28 days, to collect preliminary laboratory evidence for antiviral activity and effectiveness of three dose regimens of oral ganciclovir based on blood and urine cultures of CMV, and to relate antiviral activity to dosage and to serum ganciclovir levels. CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS. A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls. More studies are warranted to evaluate effects at different doses. CMV retinitis is an important sight-threatening opportunistic infection which affects about 10 to 15 percent of people with AIDS. A previous study has shown that treatment with ganciclovir resulted in a significant delay in time to first retinitis progression compared to untreated controls. More studies are warranted to evaluate effects at different doses. In group A, 36 HIV seropositive patients with CMV viruria receive a single dose of intravenous ganciclovir followed by one of three oral dose regimens for 28 days. Twelve individuals are treated at each dose level. In group B, 12 patients with AIDS and CMV retinitis receive oral ganciclovir therapy. These 12 patients must have received an induction course of intravenous ganciclovir for 4 weeks prior to study entry and must have stable CMV retinitis. Measurements for both groups include pharmacokinetics, safety, and tolerance (history, physical examination, hematology, and serum chemistry), and CMV blood and urine cultures. In addition, there are weekly ophthalmologic evaluations for individuals in the group B study.

Titre officielA Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir 
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 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
48 participants à inclureNombre 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.

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.
De 13 à 60 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
Cytomegalovirus Retinitis
HIV Infections
Critères

Inclusion Criteria Concurrent Medication: Allowed: * Topical acyclovir. There are two groups of patients. Group A must have: * Confirmation of HIV infection by HIV antibody testing, p24 antigen, or culture of HIV. * A positive urine culture for cytomegalovirus (CMV) within 4 weeks of study entry. * Not received prior ganciclovir therapy. Group B must have: * A diagnosis of AIDS by CDC criteria. * CMV retinitis diagnosed on funduscopic evaluation by an ophthalmologist. * Completed 4 weeks of intravenous ganciclovir with an improvement or stabilization of retinitis. The course of therapy should include a minimum of 24 days total of intravenous ganciclovir. * Patients in both groups must understand the nature of the study, agree to the tests required in the protocol, and must understand and sign an informed consent form approved by the appropriate Institutional Review Board (IRB) and by Syntex. Required: Group B: * 4 weeks of intravenous ganciclovir which should include a minimum of 24 days total of intravenous ganciclovir. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes. * Active CMV retinitis in which there is progression. * Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as \> 3 unformed stools/day. * Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar. * Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia. Concurrent Medication: Excluded: * Any investigational drug. * Acyclovir not specifically allowed. * Any other nucleoside analog. * Zidovudine (AZT). * Probenecid. * Aspirin. Patients with the following are excluded: * Macular involvement due to cytomegalovirus (CMV) retinitis in both eyes. * Active CMV retinitis in which there is progression. * CMV end organ disease. * Presence of diarrhea or other clinically significant or uncontrolled gastrointestinal disease including persistent nausea and/or abdominal pain. Diarrhea is defined as \> 3 unformed stools/day. * Dementia or decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to follow the protocol, to take assigned dose regimen reliably, and to keep a daily record on a calendar. * Significant CMV disease of other organs, including CMV gastroenteritis or CMV pneumonia. Prior Medication: Excluded within 4 days of study entry: * Antimetabolite. * Interferon. * Other nucleoside analog including zidovudine (AZT). Excluded for Group A: * Ganciclovir or other anti-cytomegalovirus 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 5 sites
Suspendu
Univ of California / San Diego Treatment CtrSan Diego, United StatesVoir le site
Suspendu
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United States
Suspendu
Davies Med CtrSan Francisco, United States
Suspendu
Mount Zion Med CtrSan Francisco, United States

Terminé5 Centres d'Étude