Completed

Ganciclovir for CMV Disease Prevention in HIV-Infected Individuals

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What is being tested

Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+10 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 evaluating the effectiveness and safety of an oral medication called Ganciclovir. The goal is to prevent a specific virus, cytomegalovirus (CMV), from developing into a disease in individuals who are also infected with the Human Immunodeficiency Virus (HIV). The study targets people with HIV who have low CD4 lymphocyte counts, which is a type of white blood cell that fights off infections, specifically those with counts equal to or less than 100 cells per cubic millimeter. The importance of this study lies in its potential to reduce the complications associated with having both CMV and HIV infections.

NCT00002095
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.
Design Details

700 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 13 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 InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsHIV InfectionsMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

6 inclusion criteria required to participate
Adequate visualization of the retina of both eyes by ophthalmologist
Allowed: Topical or ophthalmic nucleoside analogs
CD4 count <= 50 cells/mm3 (in patients WITHOUT a history of an AIDS-defining opportunistic infection or chronic gynecologic infection) OR CD4 count <= 100 cells/mm3 (in patients WITH a history of an AIDS-defining opportunistic infection or chronic gynecologic infection)
Confirmation of HIV infection
Show More Criteria
4 exclusion criteria prevent from participating
Ganciclovir, foscarnet, FIAC, FIAU, CMV hyperimmune globulin, CMV monoclonal antibody, or HPMPC within the past 60 days
History of hypersensitivity to acyclovir
Inability to comply with protocol
Presence of gastrointestinal disease or symptoms not controlled with medications (e.g., persistent nausea, abdominal pain or persistent diarrhea within the past 4 weeks that is not controllable with medication)

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 19 locations

East Bay AIDS Ctr

Berkeley, United StatesOpen East Bay AIDS Ctr in Google Maps

Kraus - Beer Med Group

Los Angeles, United States

UCSD

San Diego, United States

Davies Med Ctr / c/o HIV Institute

San Francisco, United States
Completed19 Study Centers