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

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002034

Run by

Hoffmann-La Roche

People needed

100

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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