Completed

Ganciclovir Treatment for Cytomegalovirus Colitis in AIDS Patients

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What is being tested

Ganciclovir

Drug
Who is being recruted

Blood-Borne Infections+32

+ Urogenital Diseases

+ Genital Diseases

Over 21 Years
+14 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 treating a condition called cytomegalovirus (CMV) colitis in patients with Acquired Immune Deficiency Syndrome (AIDS). CMV colitis is an infection in the large intestine caused by a virus. The study aims to show how well a drug named ganciclovir (DHPG) works against this infection. It also seeks to understand if a 2-week treatment with this drug is safe and acceptable for these patients. The results could potentially improve the care and treatment options for AIDS patients suffering from CMV colitis. During the study, participants receive ganciclovir through an intravenous (IV) line, which is a small tube inserted into a vein. The study measures the effectiveness of the drug by looking at both clinical and virologic parameters. This means they check for improvements in symptoms and signs of the infection, and also monitor the virus levels in the body. The safety of the treatment is also evaluated, observing any side effects or complications that might occur during the 2-week course of IV DHPG therapy.

NCT00002273
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

Male

Biological sex of participants that are eligible to enroll.

Over 21 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 ErrorsColonic DiseasesCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsGastroenteritisGastrointestinal DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsIntestinal DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeColitisCytomegalovirus InfectionsHIV InfectionsAIDS-Related Opportunistic InfectionsMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Criteria

4 inclusion criteria required to participate
An underlying diagnosis of AIDS by CDC surveillance definition (group IV, category c-1 or subgroup D only)
Colitis manifested clinically by diarrhea
Colon biopsy demonstrating a typical histologic picture of cytomegalovirus (CMV) disease
Cultures for CMV from blood and urine should be obtained within 1 week of study entry but need not be positive prior to entry. (A positive culture is needed for final inclusion in AN.)
10 exclusion criteria prevent from participating
Antimetabolites or interferon within 1 week of study entry
Any other investigational drug, whether or not as part of a formal clinical study
Colitis that is so severe that it would be against the patient's best interest to be treated with placebo for 2 weeks prior to being eligible to receive ganciclovir (DHPG) on a "compassionate" use basis. Patients with a colitis of this severity should be treated with DHPG on "compassionate" use basis
History of chronic or acute liver disease
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

Roche Global Development - Palo Alto

Palo Alto, United StatesOpen Roche Global Development - Palo Alto in Google Maps
CompletedOne Study Center