Completed

DHPG and Interferon Beta Combination for Cytomegalovirus Retinitis Relapse Prevention in AIDS Patients

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Study Aim

This study aims to evaluate the effectiveness of a combination treatment using DHPG and Interferon Beta in preventing the relapse of Cytomegalovirus Retinitis in patients living with AIDS.

What is being tested

Interferon beta-1b

+ Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+32

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on preventing the recurrence of cytomegalovirus retinitis, an eye infection caused by the cytomegalovirus, in individuals living with AIDS. The study combines two medications, ganciclovir (DHPG) and interferon beta, to achieve this goal. While DHPG is typically effective, it can lead to a common side effect called neutropenia, a decrease in white blood cells, in about half of the patients. Research suggests that combining DHPG with interferon beta may enhance their effectiveness against cytomegalovirus. This could allow for lower doses of DHPG, potentially reducing the risk of neutropenia. The study aims to improve care for patients with AIDS by finding a safer and more effective treatment approach for cytomegalovirus retinitis. During the study, participants receive a combination of DHPG and interferon beta. The dose of DHPG is lower than usual, while interferon beta is given in a low dose. The goal is to prevent the relapse of the eye infection without causing neutropenia. The effectiveness of this treatment approach is evaluated by monitoring the participants for any signs of infection recurrence and changes in their white blood cell counts. If the combination therapy successfully maintains remission, a subsequent phase of the study will assess maintenance therapy using a moderate dose of interferon beta alone.

NCT00002299
Principal SponsorHoffmann-La Roche
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 60 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

7 inclusion criteria required to participate
CMV cultures of throat, buffy coat, urine, and if possible, semen will be obtained

Cytomegalovirus and toxoplasmosis serologic (IgG and IgM) tests will also be performed

Patients must fulfill the CDC criteria for the diagnosis of AIDS

Patients must have a positive CMV culture from any site

Show More Criteria

1 exclusion criteria prevent from participating
Patients not meeting inclusion criteria are excluded

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 6 locations

USC

Los Angeles, United StatesOpen USC in Google Maps

UCI Med Ctr

Orange, United States

Univ of California / San Diego Treatment Ctr

San Diego, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, United States
Completed6 Study Centers