A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

HIV Infections Clinical Trial

Official title:

A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002257
• Other study ID #: 059B
• Secondary ID: ICM 1653
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1992
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the time to progression of CMV retinitis between oral ganciclovir and IV ganciclovir during 20 weeks of maintenance treatment. To compare the safety and tolerance of oral ganciclovir with IV ganciclovir therapy during 20 weeks of maintenance treatment. To describe the safety and tolerance of oral ganciclovir treatment when given concurrently with anti-retroviral treatment, e.g. zidovudine or ddI. To describe the survival of people with AIDS and CMV retinitis.

Description:

Approximately 150 subjects with AIDS and newly diagnosed CMV retinitis will be enrolled in the study to achieve 120 randomized subjects. Eligible subjects will have CMV retinitis which has been diagnosed within one month of study entry by an ophthalmologist using indirect ophthalmoscopy. Subjects will be accrued by recruitment or referral. Anyone who volunteers for the study, meets the eligibility criteria, and signs an informed consent will be eligible for entry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Patients must have the following:

• Confirmation of HIV infection by HIV-antibody testing, p24 antigen assay, or culture of HIV, or have diagnosis of AIDS by CDC criteria.

• CMV retinitis diagnosed within one month of study entry.

• Understand the nature of the study, agree to its provisions, and sign the informed consent approved by the appropriate institutional review board and Syntex.

Exclusion Criteria

Concurrent Medication:

The following are excluded:

• Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected Cytokines.

Patients with the following are excluded:

• Persistent diarrhea, nausea, or abdominal pain or other clinically significant GI symptoms or uncontrolled gastrointestinal disease. Diarrhea is defined as 3 or more unformed stools per day.

• Have ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment and photography.

• Have ocular conditions requiring immediate surgical correction (e.g. retinal tear or detachment).

• Require continuation of concomitant medications precluded by this protocol, e.g., antimetabolites, alkylating agents, selected nucleoside analogs, and selected cytokines and other medications listed in the protocol.

• History of hypersensitivity to acyclovir or ganciclovir.

• Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the subject to give informed consent or comply with the protocol.

Prior Medication:

The following are excluded:

• Previous use of anti-cytomegalovirus drug (e.g., ganciclovir, foscarnet, FIAC, or CMV hyperimmune globulin) within one month of study entry.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
Canada	Saint Paul's Hosp	Vancouver	British Columbia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Med Service	Miami	Florida
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Cornell Univ Med College	New York	New York
United States	New York Univ Med Ctr	New York	New York
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Davies Med Ctr / c/o HIV Institute	San Francisco	California
United States	Dr David Busch	San Francisco	California
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,