Completed
Foscarnet Induction and Maintenance Therapy for Gastrointestinal CMV Disease
Study Aim
This study aims to evaluate the effectiveness of Foscarnet Induction and Maintenance Therapy as a treatment for gastrointestinal CMV disease.
What is being tested
Foscarnet sodium
Drug
Who is being recruted
Blood-Borne Infections+18
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Summary
Principal SponsorAstra USA
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients receive intravenous foscarnet either as induction only for 4 weeks or as induction for 4 weeks followed by maintenance for 22 weeks. All patients are followed for 26 weeks or until relapse.
Principal SponsorAstra USA
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
145 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsGastrointestinal DiseasesHIV Infections
Criteria
2 inclusion criteria required to participate
Patients must have AIDS
Patients must have CMV GI disease
8 exclusion criteria prevent from participating
Patients taking drugs known to affect renal function are excluded
Patients taking drugs that may interact with foscarnet are excluded
Patients taking systemic acyclovir, ganciclovir, or acyclovir prodrug are excluded
Patients who have taken investigational agents other than 3TC or d4T within 7 days prior to study entry are excluded
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Los Angeles County - USC Med Ctr
Los Angeles, United StatesUCSD
San Diego, United StatesUCSF - San Francisco Gen Hosp
San Francisco, United StatesCompleted15 Study Centers