A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

HIV Infections Clinical Trial

Official title:

A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002034
• Other study ID #: 029F
• Secondary ID: ICM 1692
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 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 evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Topical acyclovir.

• Selected cytokines.

• Allowed after the first 4 weeks of ganciclovir:

• Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity.

• Other anti-retrovirals after consultation with the Syntex study monitor.

Patients must have the following:

• AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.

• An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea).

• Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.

• Ocular conditions requiring immediate surgical correction (eg:

• retinal tear or detachment).

• Demonstrated hypersensitivity to acyclovir or ganciclovir.

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

Concurrent Medication:

Excluded:

• Antimetabolites.

• Alkylating agents.

• Nucleoside analogs (excluding selected anti-retroviral agents).

• Imipenem-cilastatin.

• Interferons.

• Selected cytokines.

• Acyclovir (except topical acyclovir).

Patients with the following are excluded:

• Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea).

• Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.

Prior Medication:

Excluded within 1 month of study entry:

• Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Zidovudine

• Ganciclovir

Locations

Country	Name	City	State
Canada	Southern Alberta HIV Clinic / Foothills Hosp	Calgary	Alberta
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Dr Alfred F Burnside Jr	Columbia	South Carolina
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Summitt Med Ctr / San Francisco Gen Hosp	Oakland	California
United States	Dr Winkler Weinberg	Roswell	Georgia
United States	Stanford at Kaiser / Kaiser Permanente Med Ctr	San Francisco	California
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,