Completed

Immune Globulin and Ganciclovir Combination for CMV Retinitis in AIDS Patients

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Study Aim

This study aims to treat CMV Retinitis in AIDS patients by evaluating the effectiveness of a combination therapy using Immune Globulin and Ganciclovir.

What is being tested

Globulin, Immune

+ Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+30

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorAmerican National Red Cross
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study aims to compare the effectiveness and safety of a combination treatment using Immune Globulin and Ganciclovir (DHPG) versus Ganciclovir (DHPG) alone in treating CMV Retinitis, a sight-threatening condition in patients with AIDS. The goal is to determine if the combination treatment leads to a quicker initial response and a longer period of remission (16 weeks) than Ganciclovir alone. The study also hopes to address the current challenge of managing CMV Retinitis in AIDS patients, potentially improving their care and quality of life.

NCT00001999
Principal SponsorAmerican National Red Cross
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.

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 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 DiseasesRetinal DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsRetinitisHIV InfectionsCytomegalovirus RetinitisMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

5 inclusion criteria required to participate
Ability to understand the nature of the study, to comply with study requirements, and to sign informed consent
At least one pending culture for CMV from the blood or urine prior to entry
First episode of sight-threatening CMV retinitis
Karnofsky performance = or > 60
Show More Criteria
7 exclusion criteria prevent from participating
Concomitant treatment with other investigational agents except ddI or ddC
Continued alcohol or drug abuse
History of previous episodes of sight-threatening CMV retinitis
Karnofsky performance < 60
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

Georgetown Univ Med Ctr

Washington D.C., United StatesOpen Georgetown Univ Med Ctr in Google Maps
CompletedOne Study Center