Completed

Foscarnet Therapy Safety and Efficacy in First Episode CMV-Retinitis in AIDS Patients

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What is being tested

Foscarnet sodium

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

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 dealing with their first episode of cytomegalovirus (CMV) retinitis, an eye infection caused by the CMV virus. The main goal is to assess the safety and effectiveness of a drug called foscarnet as a treatment for this condition. The study also aims to find the best way to administer foscarnet for ongoing treatment. Additionally, the study will look into how foscarnet interacts with another drug, zidovudine (AZT), commonly used in AIDS treatment. During the study, participants will receive foscarnet as their initial treatment. After this, they will be given different maintenance therapy plans with foscarnet. The study will monitor how well the participants respond to these treatments and check for any side effects. It will also examine how the body processes foscarnet when it's taken alone or with zidovudine (AZT).

NCT00002039
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

2 inclusion criteria required to participate
Patients must be able to give informed consent
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
7 exclusion criteria prevent from participating
Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose)
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
Known allergy to foscarnet
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

Foscarnet Research Program / Park Plaza Hosp

Houston, United StatesOpen Foscarnet Research Program / Park Plaza Hosp in Google Maps
CompletedOne Study Center