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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
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* Drug: Zidovudine
* Drug: Ganciclovir


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zidovudine|nan|
|Drug: Ganciclovir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinitis, AIDS-Related Opportunistic Infections, Ganciclovir, Drug Interactions, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Zidovudine