Completed
Oral vs. Intravenous Hydration in CMV Retinitis Treatment with Foscavir
What is being tested
Foscarnet sodium
Drug
Who is being recruted
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Summary
Principal SponsorAstra USA
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous Foscavir therapy for treatment of cytomegalovirus (CMV) retinitis. Treatment continues during 2 or 3 weeks of induction Foscavir therapy.
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
112 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 DiseasesDNA Virus InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsRetinitisHIV InfectionsCytomegalovirus Retinitis
Criteria
5 inclusion criteria required to participate
Documented HIV infection
No corneal, lens, or vitreous opacification that precludes examination of the fundi
No evidence of other end organ CMV infection
No evidence of tuberculous, diabetic, or hypertensive retinopathy
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7 exclusion criteria prevent from participating
Any investigational drug
Any investigational drug within 28 days prior to study entry
Clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) OR with which hydration would be hazardous (e.g., congestive heart failure)
Considered noncompliant or unreliable for study participation
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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 11 locations
Dr Milan Fiala
Los Angeles, United StatesDr G Michael Wool
Los Angeles, United StatesAIDS Community Research Consortium
Redwood City, United StatesCompleted11 Study Centers