Suspended

Foscarnet Induction Treatment for CMV Retinitis in AIDS Patients Ineligible for Ganciclovir Therapy

What is being tested

Foscarnet sodium

Drug

Who is being recruted

Blood-Borne Infections+32

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years

+16 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 treating Cytomegalovirus (CMV) Retinitis, an eye infection caused by the CMV virus, in AIDS patients. The study is designed for patients who have previously experienced severe side effects from a drug called ganciclovir, those who can't take ganciclovir due to its potential to suppress bone marrow function, or those who didn't respond well to ganciclovir treatment. The goal is to evaluate the safety and effectiveness of another drug, foscarnet, in managing this condition. The importance of this study lies in finding a potential alternative treatment for CMV Retinitis in AIDS patients who can't tolerate or haven't responded to ganciclovir. During the study, participants receive foscarnet treatment. The study measures the safety and effectiveness of this drug by monitoring the duration of clinical response and its effect on CMV levels in blood and urine. It also assesses the impact of the treatment on the recovery of HIV p24 antigen, a protein produced by the HIV virus, directly from plasma. The study aims to understand if foscarnet can provide a beneficial treatment option for this specific group of patients.

NCT00002301

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 DiseasesAmino Acid Metabolism, Inborn ErrorsCommunicable DiseasesDNA Virus InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesOpportunistic InfectionsRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsRetinitisHIV InfectionsAIDS-Related Opportunistic InfectionsCytomegalovirus RetinitisMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

8 inclusion criteria required to participate

AIDS patients experiencing cytomegalovirus (CMV) retinitis may be enrolled

Allowed concurrent medication: Ganciclovir

Patients must be able to give informed consent

Patients presenting with a baseline absolute neutrophil count < 750 cells/mm3 or baseline platelet count < 50000 platelets/mm3 will be categorized as ineligible to receive ganciclovir induction therapy and will be allowed to enter the study

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8 exclusion criteria prevent from participating

Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose)

Corneal, lens, or vitreous opacification which precludes examination of the fundi in patients with cytomegalovirus (CMV) retinitis

Excluded concurrent medication: Acyclovir

Excluded concurrent medication: Nephrotoxic agent

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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 1 location

Foscarnet Research Program / Park Plaza Hosp

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

SuspendedOne Study Center