Completed
Foscarnet Therapy Safety and Efficacy in First-Episode CMV-Retinitis in AIDS Patients
What is being tested
Foscarnet sodium
Drug
Who is being recruted
Blood-Borne Infections+24
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorAstra USA
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on AIDS patients who are experiencing their first episode of a condition called cytomegalovirus (CMV) retinitis, an eye infection that can cause blindness. The main goal is to assess the safety and effectiveness of a drug named foscarnet as a treatment for this condition. This research is important because it aims to find a reliable treatment for CMV retinitis in AIDS patients, helping to improve their quality of life and prevent vision loss.
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.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.From 18 to 65 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 DiseasesInfectionsOpportunistic InfectionsRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsRetinitisHIV InfectionsAIDS-Related Opportunistic InfectionsCytomegalovirus Retinitis
Criteria
4 inclusion criteria required to participate
Patients must be able to give informed consent
Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to < 750 cells/mm3 or platelet count falling to < 50000 platelets/mm3 on two separate occasions during either a ganciclovir induction regimen of 7.5 mg (or more)/kg/day in divided doses or a maintenance regimen of 5 mg (or more)/kg/day as a single daily dose
Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria: CMV retinitis progression has occurred either 1) at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 mg (or more)/kg/day, at least 5 days/week) where maintenance therapy began within 1 week of completing induction therapy
Patients with AIDS as defined by the CDC, with manifest first episode cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography
6 exclusion criteria prevent from participating
Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose)
Concurrent use of acyclovir
Concurrent use of nephrotoxic drugs
Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy
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 1 location
CompletedOne Study Center